A Phase 1/2, Open-Label, Dose Escalation, Safety and Tole... | NCT02018861 | Trialant
NCT02018861
Sponsor
Incyte Corporation
Status
Completed
Last Update Posted
Sep 28, 2023Actual
Enrollment
88Actual
Phase
Phase 1Phase 2
Conditions
B-Cell Malignancies
Interventions
Parsaclisib
Itacitinib
Rituximab
Ifosfamide
Carboplatin
Etoposide
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02018861
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 50465-101 (CITADEL-101)
Secondary IDs
ID
Type
Description
Link
Parsaclisib
Other Identifier
Incyte Corporation
Brief Title
A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)
Official Title
A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Iitacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Sep 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 22, 2016Actual
Primary Completion Date
Apr 12, 2021Actual
Completion Date
Apr 12, 2021Actual
First Submitted Date
Dec 5, 2013
First Submission Date that Met QC Criteria
Dec 17, 2013
First Posted Date
Dec 23, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 7, 2022
Results First Submitted that Met QC Criteria
Jun 1, 2022
Results First Posted Date
Jun 28, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 21, 2023
Last Update Posted Date
Sep 28, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Open-label, dose-escalation study in subjects with previously treated B-cell malignancies to find maximum tolerated dose (MTD) or pharmacologic active dose of a PI3Kδ inhibitor, parsaclisib, as monotherapy and in combination with: itacitinib (INCB039110), a JAK1 inhibitor; rituximab; and rituximab, ifosfamide, carboplatin, and etoposide. Parsaclisib inhibits PI3Kδ, a protein involved in growth and survival of B-cell cancer cells.
Detailed Description
Not provided
Conditions Module
Conditions
B-Cell Malignancies
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
88Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Parsaclisib 5 mg QD
Experimental
Parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles
Drug: Parsaclisib
Parsaclisib 10 mg QD
Experimental
Parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles
Drug: Parsaclisib
Parsaclisib 15 mg QD
Experimental
Parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles
Drug: Parsaclisib
Parsaclisib 20 mg QD
Experimental
Parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles
Drug: Parsaclisib
Parsaclisib 30 mg QD
Experimental
Parsaclisib 30 mg as oral tablets QD in 21-day treatment cycles
Drug: Parsaclisib
Parsaclisib 45 mg QD
Experimental
Parsaclisib 45 mg as oral tablets QD in 21-day treatment cycles
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. Abnormal laboratory values or test results occurring after informed consent constitute AEs only if they induce clinical signs or symptoms, are considered clinically meaningful, require therapy (e.g., hematologic abnormality that requires transfusion), or require changes in the study drug(s). A TEAE is defined as an event that was reported for the first time, or the worsening of a pre-existing event, after the first dose of study drug.
Up to approximately 53 months (4.4 years)
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Overall Response Rate (Percentage of Participants With Complete Response [CR] and Partial Response [PR]) Based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria for Chronic Lymphocytic Leukemia (CLL) for CLL Participants
CR: (a) peripheral blood lymphocytes <4 x 10^9/Liter (L); (b) no significant lymphadenopathy and lymph nodes <1.5 centimeters (cm) in longest diameter; (c) no splenomegaly/hepatomegaly; (d) no disease-related constitutional symptoms; (e) neutrophils ≥1.5 x 10^9/L; (f) platelets ≥100 x 10^9/L; (g) hemoglobin ≥11.0 grams/deciliter (g/dL) (without transfusion); (h) minimal residual disease assessment; (i) normocellular marrow, with no CLL cells/no B-lymphoid nodules. PR (improvement in ≥2 Group A parameters and ≥1 Group B parameter if previously abnormal. If only 1 parameter of both Groups A and B was abnormal before therapy, only 1 needs to improve): Group A: (a) decrease of ≥50% (from Baseline) in lymph nodes, liver/spleen size, and circulating lymphocyte count; (b) any constitutional symptoms. Group B: (a) platelets ≥100 x 10^9/L or increase ≥50% over Baseline; (b) hemoglobin ≥11 g/dL or increase ≥50% over Baseline; (c) presence of CLL cells or B-lymphoid nodules.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Aged 18 years or older, with lymphoid malignancies of B-cell origin including:
EXCLUDING: Burkitt's lymphoma and precursor B lymphoblastic leukemia/lymphoma
INCLUDING: any non-Hodgkin's B cell malignancy such as chronic lymphocytic leukemia (CLL) and rare non-Hodgkin's B- cell subtypes such as hairy cell leukemia, Waldenström macroglobulinemia (WM), mantle cell leukemia (MCL), and transformed NHL histologies
Hodgkin's lymphoma (HL)
Life expectancy of 12 weeks or longer
Subject must have received ≥ 1 prior treatment regimen(s)
The subject must not be a candidate for potentially curative therapy including hematopoietic stem cell transplantation, except where one of the standard therapy regimen combinations may be used prior to transplantation per standard medical practice
Exclusion Criteria:
Has history of brain metastasis, spinal cord compression (unless treated, asymptomatic, and stable on most recent imaging and enrolling in expansion cohort), or lymphoma involving the central nervous system (CNS)
Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 3 (≥ 2 during dose escalation)
Received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (GVHD) following allogeneic transplant, or currently receiving immunosuppressive therapy following allogeneic transplant
Received autologous hematopoietic stem cell transplant within the last 3 months
Inadequate marrow reserve assessed by hematologic laboratory parameters
Inadequate renal or liver function
Known HIV infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or at risk for HBV reactivation
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Claudia Corrado, M.D.
Incyte Corporation
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Alabama At Birmingham Comprehensive Cancer Center
This was a 4-part study. Part 1 parsaclisib monotherapy dose escalation determined the recommended dose(s) (RDs) to explore. Part 2 evaluated the combination of parsaclisib and itacitinib to determine the RDs. Part 3 expansion further evaluated the RDs of parsaclisib as monotherapy and in combination with itacitinib in disease cohorts. Part 6 consisted of a safety assessment of parsaclisib in combination with the chemotherapy regimen R-ICE (rituximab, ifosfamide, carboplatin, and etoposide).
Recruitment Details
This study was conducted at 13 study centers in the United States.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
FG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
Parsaclisib 30 mg as oral tablets QD and itacitinib (INCB039110) 300 mg as oral tablets QD in 21-day treatment cycles
Drug: Parsaclisib
Drug: Itacitinib
Parsaclisib 15 mg QD + R-ICE
Placebo Comparator
Parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration
Drug: Parsaclisib
Drug: Rituximab
Drug: Ifosfamide
Drug: Carboplatin
Drug: Etoposide
Parsaclisib 20 mg QD + R-ICE
Placebo Comparator
20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
Part 2: Overall Response Rate (Percentage of Participants With CR and PR) Based on IWCLL Criteria for CLL for Participants With CLL
CR: (a) peripheral blood lymphocytes <4 x 10^9/L; (b) no significant lymphadenopathy and lymph nodes <1.5 cm in longest diameter; (c) no splenomegaly/hepatomegaly; (d) no disease-related constitutional symptoms; (e) neutrophils ≥1.5 x 10^9/L; (f) platelets ≥100 x 10^9/L; (g) hemoglobin ≥11.0 g/dL (without transfusion); (h) minimal residual disease assessment; (i) normocellular marrow, with no CLL cells/no B-lymphoid nodules. PR (improvement in ≥2 Group A parameters and ≥1 Group B parameter if previously abnormal. If only 1 parameter of both Groups A and B was abnormal before therapy, only 1 needs to improve): Group A: (a) decrease of ≥50% (from Baseline) in lymph nodes, liver/spleen size, and circulating lymphocyte count; (b) any constitutional symptoms. Group B: (a) platelets ≥100 x 10^9/L or increase ≥50% over Baseline; (b) ≥11 g/dL or increase ≥50% over Baseline; (c) presence of CLL cells or B-lymphoid nodules.
Up to approximately 44 months (3.7 years)
Part 6: Overall Response Rate (Percentage of Participants With CR and PR) Based on IWCLL Criteria for CLL for Participants With CLL
CR: (a) peripheral blood lymphocytes <4 x 10^9/L; (b) no significant lymphadenopathy and lymph nodes <1.5 cm in longest diameter; (c) no splenomegaly/hepatomegaly; (d) no disease-related constitutional symptoms; (e) neutrophils ≥1.5 x 10^9/L; (f) platelets ≥100 x 10^9/L; (g) hemoglobin ≥11.0 g/dL (without transfusion); (h) minimal residual disease assessment; (i) normocellular marrow, with no CLL cells/no B-lymphoid nodules. PR (improvement in ≥2 Group A parameters and ≥1 Group B parameter if previously abnormal. If only 1 parameter of both Groups A and B was abnormal before therapy, only 1 needs to improve): Group A: (a) decrease of ≥50% (from Baseline) in lymph nodes, liver/spleen size, and circulating lymphocyte count; (b) any constitutional symptoms. Group B: (a) platelets ≥100 x 10^9/L or increase ≥50% over Baseline; (b) ≥11 g/dL or increase ≥50% over Baseline; (c) presence of CLL cells or B-lymphoid nodules.
Up to approximately 4 months
Part 1: ORR Based on the VIth International Workshop on Waldenström Macroglobulinemia (WM) Response Assessment for Participants With WM
ORR: sum of participants achieving minor response (MR), PR, very good partial response (VGPR), and CR. CR: (a) no serum monoclonal IgM protein by immunofixation; (b) normal serum IgM level; (c) complete resolution of extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at Baseline (BL); (d) morphologically normal bone marrow aspirate and trephine biopsy. VGPR: (a) detectable monoclonal IgM protein; (b) ≥90% reduction in serum IgM level from BL; (c) complete resolution of extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) no new signs/symptoms of active disease. PR: (a) detectable monoclonal IgM protein; (b) ≥50% but <90% reduction in serum IgM level from BL; (c) reduction in extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) no new signs/symptoms of active disease. MR: (a) detectable monoclonal IgM protein; (b) ≥25% but <50% reduction in serum IgM level from BL; (d) no new signs/symptoms of active disease.
Up to approximately 53 months (4.4 years)
Part 2: ORR Based on the VIth International Workshop on WM Response Assessment for Participants With WM
ORR: sum of participants achieving MR, PR, VGPR, and CR. CR: (a) no serum monoclonal IgM protein by immunofixation; (b) normal serum IgM level; (c) complete resolution of extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) morphologically normal bone marrow aspirate and trephine biopsy. VGPR: (a) detectable monoclonal IgM protein; (b) ≥90% reduction in serum IgM level from BL; (c) complete resolution of extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) no new signs/symptoms of active disease. PR: (a) detectable monoclonal IgM protein; (b) ≥50% but <90% reduction in serum IgM level from BL; (c) reduction in extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) no new signs/symptoms of active disease. MR: (a) detectable monoclonal IgM protein; (b) ≥25% but <50% reduction in serum IgM level from BL; (d) no new signs/symptoms of active disease.
Up to approximately 44 months (3.7 years)
Part 6: ORR Based on the VIth International Workshop on WM Response Assessment for Participants With WM
ORR: sum of participants achieving MR, PR, VGPR, and CR. CR: (a) no serum monoclonal IgM protein by immunofixation; (b) normal serum IgM level; (c) complete resolution of extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) morphologically normal bone marrow aspirate and trephine biopsy. VGPR: (a) detectable monoclonal IgM protein; (b) ≥90% reduction in serum IgM level from BL; (c) complete resolution of extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) no new signs/symptoms of active disease. PR: (a) detectable monoclonal IgM protein; (b) ≥50% but <90% reduction in serum IgM level from BL; (c) reduction in extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) no new signs/symptoms of active disease. MR: (a) detectable monoclonal IgM protein; (b) ≥25% but <50% reduction in serum IgM level from BL; (d) no new signs/symptoms of active disease.
Up to approximately 4 months
Part 1: ORR (Sum of Participants With CR and PR) Based on the Revised Response Criteria for Hodgkin's Lymphoma (HL) and Non-Hodgkin's Lymphoma (NHL), Using Positron Emission Tomography-computed Tomography (PET-CT) and CT
CR, PET-CT: (a) complete metabolic response (MR); (b) lymph nodes and extralymphatic sites (LNs/ELSs): score 1, 2, or 3, with/without residual mass; (c) no new lesions (NNLs); (d) no evidence of fluorodeoxyglucose-avid disease in marrow. CT: complete radiologic response: (a) regression of target nodes/nodal masses to ≤ 1.5 cm in longest transverse lesion diameter; (b) no ELSs of disease; (c) absence of nonmeasured lesions; (d) regression to normal organ size; (e) NNLs; (f) normal morphological bone marrow. PR, PET-CT: (a) partial MR; (b) LNs/ELSs: score 4 or 5, with reduced uptake compared with Baseline and residual mass of any size; (c) NNLs; (d) residual uptake higher than uptake in normal marrow but reduced compared with Baseline. CT: partial remission: (a) LNs/ELSs: ≥ 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions of up to 6 target measurable sites; (b) spleen must have regressed by > 50% in length beyond normal; (c) NNLs.
Up to approximately 53 months (4.4 years)
Part 2: ORR (Sum of Participants With CR and PR) Based on the Revised Response Criteria for HL and NHL, Using PET-CT and CT
CR, PET-CT: (a) complete MR; (b) LNs/ELSs: score 1, 2, or 3, with/without residual mass; (c) NNLs; (d) no evidence of fluorodeoxyglucose-avid disease in marrow. CT: complete radiologic response: (a) regression of target nodes/nodal masses to ≤ 1.5 cm in longest transverse lesion diameter; (b) no ELSs of disease; (c) absence of nonmeasured lesions; (d) regression to normal organ size; (e) NNLs; (f) normal morphological bone marrow. PR, PET-CT: (a) partial MR; (b) LNs/ELSs: score 4 or 5, with reduced uptake compared with Baseline and residual mass of any size; (c) NNLs; (d) residual uptake higher than uptake in normal marrow but reduced compared with Baseline. CT: partial remission: (a) LNs/ELSs: ≥ 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions of up to 6 target measurable sites; (b) spleen must have regressed by > 50% in length beyond normal; (c) NNLs.
Up to approximately 44 months (3.7 years)
Part 6: ORR (Sum of Participants With CR and PR) Based on the Revised Response Criteria for HL and NHL, Using PET-CT and CT
CR, PET-CT: (a) complete MR; (b) LNs/ELSs: score 1, 2, or 3, with/without residual mass; (c) NNLs; (d) no evidence of fluorodeoxyglucose-avid disease in marrow. CT: complete radiologic response: (a) regression of target nodes/nodal masses to ≤ 1.5 cm in longest transverse lesion diameter; (b) no ELSs of disease; (c) absence of nonmeasured lesions; (d) regression to normal organ size; (e) NNLs; (f) normal morphological bone marrow. PR, PET-CT: (a) partial MR; (b) LNs/ELSs: score 4 or 5, with reduced uptake compared with Baseline and residual mass of any size; (c) NNLs; (d) residual uptake higher than uptake in normal marrow but reduced compared with Baseline. CT: partial remission: (a) LNs/ELSs: ≥ 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions of up to 6 target measurable sites; (b) spleen must have regressed by > 50% in length beyond normal; (c) NNLs.
Up to approximately 4 months
Cmax of Itacitinib in Combination With Parsaclisib
Cmax is defined as the maximum observed plasma or serum concentration of itacitinib.
Cycle 1 Day 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
Tmax of Itacitinib in Combination With Parsaclisib
tmax is defined as the time to the maximum concentration of itacitinib.
Cycle 1 Day 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
Cmin of Itacitinib in Combination With Parsaclisib
Cmin is defined as the minimum observed plasma or serum concentration over the dose interval of itacitinib.
Cycle 1 Day 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
AUC0-t of Itacitinib in Combination With Parsaclisib
AUC0-t is defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of itacitinib.
Cycle 1 Day 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
AUC0-τ of Itacitinib in Combination With Parsaclisib
AUC0-τ is defined as the area under the steady-state plasma or serum concentration-time curve over 1 dose interval (i.e., from hour 0 to 12 for once every 12 hours [q12h] administration or from hour 0 to 24 for once every 24 hours [q24h] administration) of itacitinib.
Cycle 1 Day 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
Parts 1 and 2: Cmax of Parsaclisib as Monotherapy and in Combination With Itacitinib
Cmax is defined as the maximum observed plasma or serum concentration of parsaclisib. PK samples collected in Part 2, the combination dose escalation study, and in Part 3, Cohort E expansion group, were analyzed for both parsaclisib and itacitinib.
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
Parts 1 and 2: Tmax of Parsaclisib as Monotherapy and in Combination With Itacitinib
tmax is defined as the time to the maximum concentration of parsaclisib. PK samples collected in Part 2, the combination dose escalation study, and in Part 3, Cohort E expansion group, were analyzed for both parsaclisib and itacitinib.
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
Parts 1 and 2: Cmin of Parsaclisib as Monotherapy and in Combination With Itacitinib
Cmin is defined as the minimum observed plasma or serum concentration over the dose interval of parsaclisib. PK samples collected in Part 2, the combination dose escalation study, and in Part 3, Cohort E expansion group, were analyzed for both parsaclisib and itacitinib.
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
Parts 1 and 2: AUC0-t of Parsaclisib as Monotherapy and in Combination With Itacitinib
AUC0-t is defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of parsaclisib. PK samples collected in Part 2, the combination dose escalation study, and in Part 3, Cohort E expansion group, were analyzed for both parsaclisib and itacitinib.
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
Parts 1 and 2: AUC0-τ of Parsaclisib as Monotherapy and in Combination With Itacitinib
AUC0-τ is defined as the area under the steady-state plasma or serum concentration-time curve over 1 dose interval (i.e., from hour 0 to 12 for q12h administration or from hour 0 to 24 for q24h administration) of parsaclisib. PK samples collected in Part 2, the combination dose escalation study, and in Part 3, Cohort E expansion group, were analyzed for both parsaclisib and itacitinib.
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
Part 3: Cmax of Parsaclisib Monotherapy
Cmax is defined as the maximum observed plasma or serum concentration of parsaclisib. PK samples for parsaclisib monotherapy were collected and analyzed from the Part 3 dose expansion (different participant populations). Cohort A: B-cell malignancies; Cohort B: Hodgkin's lymphoma; Cohort C: diffuse large B-cell lymphoma; Cohort D: indolent lymphoma.
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
Part 3: Tmax of Parsaclisib Monotherapy
tmax is defined as the time to the maximum concentration of parsaclisib. PK samples for parsaclisib monotherapy were collected and analyzed from the Part 3 dose expansion (different participant populations). Cohort A: B-cell malignancies; Cohort B: Hodgkin's lymphoma; Cohort C: diffuse large B-cell lymphoma; Cohort D: indolent lymphoma.
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
Part 3: Cmin of Parsaclisib Monotherapy
Cmin is defined as the minimum observed plasma or serum concentration over the dose interval of parsaclisib. PK samples for parsaclisib monotherapy were collected and analyzed from the Part 3 dose expansion (different participant populations). Cohort A: B-cell malignancies; Cohort B: Hodgkin's lymphoma; Cohort C: diffuse large B-cell lymphoma; Cohort D: indolent lymphoma.
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
Part 3: AUC0-t of Parsaclisib Monotherapy
AUC0-t is defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of of parsaclisib. PK samples for parsaclisib monotherapy were collected and analyzed from the Part 3 dose expansion (different participant populations). Cohort A: B-cell malignancies; Cohort B: Hodgkin's lymphoma; Cohort C: diffuse large B-cell lymphoma; Cohort D: indolent lymphoma.
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
Part 3: AUC0-τ of Parsaclisib Monotherapy
AUC0-τ is defined as the area under the steady-state plasma or serum concentration-time curve over 1 dose interval (i.e., from hour 0 to 12 for once every 12 hours [q12h] administration or from hour 0 to 24 for once every 24 hours [q24h] administration) of parsaclisib. PK samples for parsaclisib monotherapy were collected and analyzed from the Part 3 dose expansion (different participant populations). Cohort A: B-cell malignancies; Cohort B: Hodgkin's lymphoma; Cohort C: diffuse large B-cell lymphoma; Cohort D: indolent lymphoma.
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
University of Michigan Cancer Center
Ann Arbor
Michigan
48109
United States
Karmanos Cancer Institute
Detroit
Michigan
48201
United States
Nyu Langone Laura and Isaac Perlmutter Cancer Center
New York
New York
10016
United States
University Hospitals Case Medical Center
Cleveland
Ohio
44106
United States
Greenville Health System Cancer Institute
Greenville
South Carolina
29605
United States
Baylor Charles A. Sammons Cancer Center
Dallas
Texas
75246
United States
FG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
FG003
Parsaclisib 20 mg QD
Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles.
FG004
Parsaclisib 30 mg QD
Participants self-administered parsaclisib 30 mg as oral tablets QD in 21-day treatment cycles.
FG005
Parsaclisib 45 mg QD
Participants self-administered parsaclisib 45 mg as oral tablets QD in 21-day treatment cycles.
FG006
Parsaclisib 20 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 20 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
FG007
Parsaclisib 30 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
FG008
Parsaclisib 15 mg QD + R-ICE
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
FG009
Parsaclisib 20 mg QD + R-ICE
Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG00334 subjects
FG00427 subjects
FG0054 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG00330 subjects
FG00427 subjects
FG0054 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0036 subjects
FG0044 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Disease Progression
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG00313 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Non-compliance with Study Treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
FG004
Unknown or Not Reported
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Parsaclisib + Itacitinib; 21-day Cycles
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0068 subjects
FG0073 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Disease Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Parsaclisib + R-ICE; 21-day Cycles
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0084 subjects
FG0091 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
BG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
BG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
BG003
Parsaclisib 20 mg QD
Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles.
BG004
Parsaclisib 30 mg QD
Participants self-administered parsaclisib 30 mg as oral tablets QD in 21-day treatment cycles.
BG005
Parsaclisib 45 mg QD
Participants self-administered parsaclisib 45 mg as oral tablets QD in 21-day treatment cycles.
BG006
Parsaclisib 20 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 20 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
BG007
Parsaclisib 30 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
BG008
Parsaclisib 15 mg QD + R-ICE
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
BG009
Parsaclisib 20 mg QD + R-ICE
Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0013
BG0023
BG00334
BG00427
BG0054
BG0068
BG0073
BG0084
BG0091
BG01088
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG000NA± NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG00169.0± 16.52
BG00263.3
Sex/Gender, Customized
Number
participants
Title
Denominators
Categories
Female
Title
Measurements
BG000NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG001NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Black or African American
Title
Measurements
BG000NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG001NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. Abnormal laboratory values or test results occurring after informed consent constitute AEs only if they induce clinical signs or symptoms, are considered clinically meaningful, require therapy (e.g., hematologic abnormality that requires transfusion), or require changes in the study drug(s). A TEAE is defined as an event that was reported for the first time, or the worsening of a pre-existing event, after the first dose of study drug.
Safety Population: all participants enrolled in the study who received at least 1 dose of parsaclisib, itacitinib, rituximab, ifosfamide, carboplatin, and/or etoposide
Posted
Count of Participants
Participants
Up to approximately 53 months (4.4 years)
ID
Title
Description
OG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
OG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
OG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
OG003
Parsaclisib 20 mg QD
Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles.
OG004
Parsaclisib 30 mg QD
Participants self-administered parsaclisib 30 mg as oral tablets QD in 21-day treatment cycles.
OG005
Parsaclisib 45 mg QD
Participants self-administered parsaclisib 45 mg as oral tablets QD in 21-day treatment cycles.
OG006
Parsaclisib 20 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 20 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
OG007
Parsaclisib 30 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
OG008
Parsaclisib 15 mg QD + R-ICE
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
OG009
Parsaclisib 20 mg QD + R-ICE
Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0013
OG0023
OG003
Secondary
Part 1: Overall Response Rate (Percentage of Participants With Complete Response [CR] and Partial Response [PR]) Based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria for Chronic Lymphocytic Leukemia (CLL) for CLL Participants
CR: (a) peripheral blood lymphocytes <4 x 10^9/Liter (L); (b) no significant lymphadenopathy and lymph nodes <1.5 centimeters (cm) in longest diameter; (c) no splenomegaly/hepatomegaly; (d) no disease-related constitutional symptoms; (e) neutrophils ≥1.5 x 10^9/L; (f) platelets ≥100 x 10^9/L; (g) hemoglobin ≥11.0 grams/deciliter (g/dL) (without transfusion); (h) minimal residual disease assessment; (i) normocellular marrow, with no CLL cells/no B-lymphoid nodules. PR (improvement in ≥2 Group A parameters and ≥1 Group B parameter if previously abnormal. If only 1 parameter of both Groups A and B was abnormal before therapy, only 1 needs to improve): Group A: (a) decrease of ≥50% (from Baseline) in lymph nodes, liver/spleen size, and circulating lymphocyte count; (b) any constitutional symptoms. Group B: (a) platelets ≥100 x 10^9/L or increase ≥50% over Baseline; (b) hemoglobin ≥11 g/dL or increase ≥50% over Baseline; (c) presence of CLL cells or B-lymphoid nodules.
Intent-to-Treat (ITT) Population: all participants with CLL enrolled in the study who received at least 1 dose of parsaclisib, itacitinib, rituximab, ifosfamide, carboplatin, and/or etoposide. Confidence intervals were calculated based on the exact method for binomial distributions.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 53 months (4.4 years)
ID
Title
Description
OG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
Secondary
Part 2: Overall Response Rate (Percentage of Participants With CR and PR) Based on IWCLL Criteria for CLL for Participants With CLL
CR: (a) peripheral blood lymphocytes <4 x 10^9/L; (b) no significant lymphadenopathy and lymph nodes <1.5 cm in longest diameter; (c) no splenomegaly/hepatomegaly; (d) no disease-related constitutional symptoms; (e) neutrophils ≥1.5 x 10^9/L; (f) platelets ≥100 x 10^9/L; (g) hemoglobin ≥11.0 g/dL (without transfusion); (h) minimal residual disease assessment; (i) normocellular marrow, with no CLL cells/no B-lymphoid nodules. PR (improvement in ≥2 Group A parameters and ≥1 Group B parameter if previously abnormal. If only 1 parameter of both Groups A and B was abnormal before therapy, only 1 needs to improve): Group A: (a) decrease of ≥50% (from Baseline) in lymph nodes, liver/spleen size, and circulating lymphocyte count; (b) any constitutional symptoms. Group B: (a) platelets ≥100 x 10^9/L or increase ≥50% over Baseline; (b) ≥11 g/dL or increase ≥50% over Baseline; (c) presence of CLL cells or B-lymphoid nodules.
ITT Population: all participants with CLL. Confidence intervals were calculated based on the exact method for binomial distributions.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 44 months (3.7 years)
ID
Title
Description
OG000
Parsaclisib 20 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 20 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
OG001
Parsaclisib 30 mg + Itacitinib 300 mg
Secondary
Part 6: Overall Response Rate (Percentage of Participants With CR and PR) Based on IWCLL Criteria for CLL for Participants With CLL
CR: (a) peripheral blood lymphocytes <4 x 10^9/L; (b) no significant lymphadenopathy and lymph nodes <1.5 cm in longest diameter; (c) no splenomegaly/hepatomegaly; (d) no disease-related constitutional symptoms; (e) neutrophils ≥1.5 x 10^9/L; (f) platelets ≥100 x 10^9/L; (g) hemoglobin ≥11.0 g/dL (without transfusion); (h) minimal residual disease assessment; (i) normocellular marrow, with no CLL cells/no B-lymphoid nodules. PR (improvement in ≥2 Group A parameters and ≥1 Group B parameter if previously abnormal. If only 1 parameter of both Groups A and B was abnormal before therapy, only 1 needs to improve): Group A: (a) decrease of ≥50% (from Baseline) in lymph nodes, liver/spleen size, and circulating lymphocyte count; (b) any constitutional symptoms. Group B: (a) platelets ≥100 x 10^9/L or increase ≥50% over Baseline; (b) ≥11 g/dL or increase ≥50% over Baseline; (c) presence of CLL cells or B-lymphoid nodules.
ITT Population: all participants with CLL
Posted
Up to approximately 4 months
ID
Title
Description
OG000
Parsaclisib 15 mg QD + R-ICE
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
Secondary
Part 1: ORR Based on the VIth International Workshop on Waldenström Macroglobulinemia (WM) Response Assessment for Participants With WM
ORR: sum of participants achieving minor response (MR), PR, very good partial response (VGPR), and CR. CR: (a) no serum monoclonal IgM protein by immunofixation; (b) normal serum IgM level; (c) complete resolution of extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at Baseline (BL); (d) morphologically normal bone marrow aspirate and trephine biopsy. VGPR: (a) detectable monoclonal IgM protein; (b) ≥90% reduction in serum IgM level from BL; (c) complete resolution of extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) no new signs/symptoms of active disease. PR: (a) detectable monoclonal IgM protein; (b) ≥50% but <90% reduction in serum IgM level from BL; (c) reduction in extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) no new signs/symptoms of active disease. MR: (a) detectable monoclonal IgM protein; (b) ≥25% but <50% reduction in serum IgM level from BL; (d) no new signs/symptoms of active disease.
ITT Population: all participants with WM. Confidence intervals were calculated based on the exact method for binomial distributions.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 53 months (4.4 years)
ID
Title
Description
OG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
OG001
Parsaclisib 10 mg QD
Secondary
Part 2: ORR Based on the VIth International Workshop on WM Response Assessment for Participants With WM
ORR: sum of participants achieving MR, PR, VGPR, and CR. CR: (a) no serum monoclonal IgM protein by immunofixation; (b) normal serum IgM level; (c) complete resolution of extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) morphologically normal bone marrow aspirate and trephine biopsy. VGPR: (a) detectable monoclonal IgM protein; (b) ≥90% reduction in serum IgM level from BL; (c) complete resolution of extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) no new signs/symptoms of active disease. PR: (a) detectable monoclonal IgM protein; (b) ≥50% but <90% reduction in serum IgM level from BL; (c) reduction in extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) no new signs/symptoms of active disease. MR: (a) detectable monoclonal IgM protein; (b) ≥25% but <50% reduction in serum IgM level from BL; (d) no new signs/symptoms of active disease.
ITT Population: all participants with WM. Confidence intervals were calculated based on the exact method for binomial distributions.
Posted
Up to approximately 44 months (3.7 years)
ID
Title
Description
OG000
Parsaclisib 20 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 20 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
OG001
Parsaclisib 30 mg + Itacitinib 300 mg
Secondary
Part 6: ORR Based on the VIth International Workshop on WM Response Assessment for Participants With WM
ORR: sum of participants achieving MR, PR, VGPR, and CR. CR: (a) no serum monoclonal IgM protein by immunofixation; (b) normal serum IgM level; (c) complete resolution of extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) morphologically normal bone marrow aspirate and trephine biopsy. VGPR: (a) detectable monoclonal IgM protein; (b) ≥90% reduction in serum IgM level from BL; (c) complete resolution of extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) no new signs/symptoms of active disease. PR: (a) detectable monoclonal IgM protein; (b) ≥50% but <90% reduction in serum IgM level from BL; (c) reduction in extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at BL; (d) no new signs/symptoms of active disease. MR: (a) detectable monoclonal IgM protein; (b) ≥25% but <50% reduction in serum IgM level from BL; (d) no new signs/symptoms of active disease.
ITT Population: all participants with WM
Posted
Up to approximately 4 months
ID
Title
Description
OG000
Parsaclisib 15 mg QD + R-ICE
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
Secondary
Part 1: ORR (Sum of Participants With CR and PR) Based on the Revised Response Criteria for Hodgkin's Lymphoma (HL) and Non-Hodgkin's Lymphoma (NHL), Using Positron Emission Tomography-computed Tomography (PET-CT) and CT
CR, PET-CT: (a) complete metabolic response (MR); (b) lymph nodes and extralymphatic sites (LNs/ELSs): score 1, 2, or 3, with/without residual mass; (c) no new lesions (NNLs); (d) no evidence of fluorodeoxyglucose-avid disease in marrow. CT: complete radiologic response: (a) regression of target nodes/nodal masses to ≤ 1.5 cm in longest transverse lesion diameter; (b) no ELSs of disease; (c) absence of nonmeasured lesions; (d) regression to normal organ size; (e) NNLs; (f) normal morphological bone marrow. PR, PET-CT: (a) partial MR; (b) LNs/ELSs: score 4 or 5, with reduced uptake compared with Baseline and residual mass of any size; (c) NNLs; (d) residual uptake higher than uptake in normal marrow but reduced compared with Baseline. CT: partial remission: (a) LNs/ELSs: ≥ 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions of up to 6 target measurable sites; (b) spleen must have regressed by > 50% in length beyond normal; (c) NNLs.
ITT Population: all participants with the indicated types of HL and NHL. Confidence intervals were calculated based on the exact method for binomial distributions.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 53 months (4.4 years)
ID
Title
Description
OG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
Secondary
Part 2: ORR (Sum of Participants With CR and PR) Based on the Revised Response Criteria for HL and NHL, Using PET-CT and CT
CR, PET-CT: (a) complete MR; (b) LNs/ELSs: score 1, 2, or 3, with/without residual mass; (c) NNLs; (d) no evidence of fluorodeoxyglucose-avid disease in marrow. CT: complete radiologic response: (a) regression of target nodes/nodal masses to ≤ 1.5 cm in longest transverse lesion diameter; (b) no ELSs of disease; (c) absence of nonmeasured lesions; (d) regression to normal organ size; (e) NNLs; (f) normal morphological bone marrow. PR, PET-CT: (a) partial MR; (b) LNs/ELSs: score 4 or 5, with reduced uptake compared with Baseline and residual mass of any size; (c) NNLs; (d) residual uptake higher than uptake in normal marrow but reduced compared with Baseline. CT: partial remission: (a) LNs/ELSs: ≥ 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions of up to 6 target measurable sites; (b) spleen must have regressed by > 50% in length beyond normal; (c) NNLs.
ITT Population: all participants with the indicated types of HL and NHL. Confidence intervals were calculated based on the exact method for binomial distributions.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 44 months (3.7 years)
ID
Title
Description
OG000
Parsaclisib 20 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 20 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
OG001
Parsaclisib 30 mg + Itacitinib 300 mg
Secondary
Part 6: ORR (Sum of Participants With CR and PR) Based on the Revised Response Criteria for HL and NHL, Using PET-CT and CT
CR, PET-CT: (a) complete MR; (b) LNs/ELSs: score 1, 2, or 3, with/without residual mass; (c) NNLs; (d) no evidence of fluorodeoxyglucose-avid disease in marrow. CT: complete radiologic response: (a) regression of target nodes/nodal masses to ≤ 1.5 cm in longest transverse lesion diameter; (b) no ELSs of disease; (c) absence of nonmeasured lesions; (d) regression to normal organ size; (e) NNLs; (f) normal morphological bone marrow. PR, PET-CT: (a) partial MR; (b) LNs/ELSs: score 4 or 5, with reduced uptake compared with Baseline and residual mass of any size; (c) NNLs; (d) residual uptake higher than uptake in normal marrow but reduced compared with Baseline. CT: partial remission: (a) LNs/ELSs: ≥ 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions of up to 6 target measurable sites; (b) spleen must have regressed by > 50% in length beyond normal; (c) NNLs.
ITT Population: all participants with the indicated types of HL and NHL
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 4 months
ID
Title
Description
OG000
Parsaclisib 15 mg QD + R-ICE
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
Secondary
Cmax of Itacitinib in Combination With Parsaclisib
Cmax is defined as the maximum observed plasma or serum concentration of itacitinib.
Pharmacokinetic (PK)/Pharmacodynamics (PD) Population: participants in the ITT/Safety Population who had PK/PD data. Data from the parsaclisib 20 mg + itacitinib 300 mg and the parsaclisib 30 mg + itacitinib 300 mg arms were pooled for analysis because all participants received 300 mg itacitinib and there is no drug-drug interaction between parsaclisib and itacitinib to affect the PK of either drug.
Posted
Mean
Standard Deviation
nanomoles (nmol)
Cycle 1 Day 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Parsaclisib 20/30 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 20 mg or 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
Units
Counts
Participants
OG000
Secondary
Tmax of Itacitinib in Combination With Parsaclisib
tmax is defined as the time to the maximum concentration of itacitinib.
PK/PD Population. Data from the parsaclisib 20 mg + itacitinib 300 mg and the parsaclisib 30 mg + itacitinib 300 mg arms were pooled for analysis because all participants received 300 mg itacitinib and there is no drug-drug interaction between parsaclisib and itacitinib to affect the PK of either drug.
Posted
Median
Full Range
hours
Cycle 1 Day 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Parsaclisib 20/30 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 20 or 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
Units
Counts
Participants
OG000
Secondary
Cmin of Itacitinib in Combination With Parsaclisib
Cmin is defined as the minimum observed plasma or serum concentration over the dose interval of itacitinib.
PK/PD Population. Data from the parsaclisib 20 mg + itacitinib 300 mg and the parsaclisib 30 mg + itacitinib 300 mg arms were pooled for analysis because all participants received 300 mg itacitinib and there is no drug-drug interaction between parsaclisib and itacitinib to affect the PK of either drug.
Posted
Mean
Standard Deviation
nmol
Cycle 1 Day 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Parsaclisib 20/30 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 20 or 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
Units
Counts
Participants
OG000
Secondary
AUC0-t of Itacitinib in Combination With Parsaclisib
AUC0-t is defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of itacitinib.
PK/PD Population. Data from the parsaclisib 20 mg + itacitinib 300 mg and the parsaclisib 30 mg + itacitinib 300 mg arms were pooled for analysis because all participants received 300 mg itacitinib and there is no drug-drug interaction between parsaclisib and itacitinib to affect the PK of either drug.
Posted
Mean
Standard Deviation
hours (hr)*nmol/L
Cycle 1 Day 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Parsaclisib 20/30 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 20 or 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
Units
Counts
Participants
OG000
Secondary
AUC0-τ of Itacitinib in Combination With Parsaclisib
AUC0-τ is defined as the area under the steady-state plasma or serum concentration-time curve over 1 dose interval (i.e., from hour 0 to 12 for once every 12 hours [q12h] administration or from hour 0 to 24 for once every 24 hours [q24h] administration) of itacitinib.
PK/PD Population. Data from the parsaclisib 20 mg + itacitinib 300 mg and the parsaclisib 30 mg + itacitinib 300 mg arms were pooled for analysis because all participants received 300 mg itacitinib and there is no drug-drug interaction between parsaclisib and itacitinib to affect the PK of either drug.
Posted
Mean
Standard Deviation
hr*nmol/L
Cycle 1 Day 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Parsaclisib 20/30 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 20 or 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
Units
Counts
Participants
OG000
Secondary
Parts 1 and 2: Cmax of Parsaclisib as Monotherapy and in Combination With Itacitinib
Cmax is defined as the maximum observed plasma or serum concentration of parsaclisib. PK samples collected in Part 2, the combination dose escalation study, and in Part 3, Cohort E expansion group, were analyzed for both parsaclisib and itacitinib.
PK/PD Population. Only participants with available data were analyzed. In the combination therapy arms, data are reported for the Part 3 Cohort E population (participants with B-cell malignancies).
Posted
Mean
Standard Deviation
nmol
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
OG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
OG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
OG003
Secondary
Parts 1 and 2: Tmax of Parsaclisib as Monotherapy and in Combination With Itacitinib
tmax is defined as the time to the maximum concentration of parsaclisib. PK samples collected in Part 2, the combination dose escalation study, and in Part 3, Cohort E expansion group, were analyzed for both parsaclisib and itacitinib.
PK/PD Population. Only participants with available data were analyzed. In the combination therapy arms, data are reported for the Part 3 Cohort E population (participants with B-cell malignancies).
Posted
Median
Full Range
hours
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
OG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
OG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
OG003
Secondary
Parts 1 and 2: Cmin of Parsaclisib as Monotherapy and in Combination With Itacitinib
Cmin is defined as the minimum observed plasma or serum concentration over the dose interval of parsaclisib. PK samples collected in Part 2, the combination dose escalation study, and in Part 3, Cohort E expansion group, were analyzed for both parsaclisib and itacitinib.
PK/PD Population. Only participants with available data were analyzed. In the combination therapy arms, data are reported for the Part 3 Cohort E population (participants with B-cell malignancies).
Posted
Mean
Standard Deviation
nmol
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
OG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
OG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
Secondary
Parts 1 and 2: AUC0-t of Parsaclisib as Monotherapy and in Combination With Itacitinib
AUC0-t is defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of parsaclisib. PK samples collected in Part 2, the combination dose escalation study, and in Part 3, Cohort E expansion group, were analyzed for both parsaclisib and itacitinib.
PK/PD Population. Only participants with available data were analyzed. In the combination therapy arms, data are reported for the Part 3 Cohort E population (participants with B-cell malignancies).
Posted
Mean
Standard Deviation
hr*nmol/L
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
OG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
OG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
Secondary
Parts 1 and 2: AUC0-τ of Parsaclisib as Monotherapy and in Combination With Itacitinib
AUC0-τ is defined as the area under the steady-state plasma or serum concentration-time curve over 1 dose interval (i.e., from hour 0 to 12 for q12h administration or from hour 0 to 24 for q24h administration) of parsaclisib. PK samples collected in Part 2, the combination dose escalation study, and in Part 3, Cohort E expansion group, were analyzed for both parsaclisib and itacitinib.
PK/PD Population. Only participants with available data were analyzed. In the combination therapy arms, data are reported for the Part 3 Cohort E population (participants with B-cell malignancies).
Posted
Mean
Standard Deviation
hr*nmol/L
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
OG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
OG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
Secondary
Part 3: Cmax of Parsaclisib Monotherapy
Cmax is defined as the maximum observed plasma or serum concentration of parsaclisib. PK samples for parsaclisib monotherapy were collected and analyzed from the Part 3 dose expansion (different participant populations). Cohort A: B-cell malignancies; Cohort B: Hodgkin's lymphoma; Cohort C: diffuse large B-cell lymphoma; Cohort D: indolent lymphoma.
PK/PD Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
nmol
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
OG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
OG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
OG003
Parsaclisib 20 mg QD
Secondary
Part 3: Tmax of Parsaclisib Monotherapy
tmax is defined as the time to the maximum concentration of parsaclisib. PK samples for parsaclisib monotherapy were collected and analyzed from the Part 3 dose expansion (different participant populations). Cohort A: B-cell malignancies; Cohort B: Hodgkin's lymphoma; Cohort C: diffuse large B-cell lymphoma; Cohort D: indolent lymphoma.
PK/PD Population. Only participants with available data were analyzed.
Posted
Median
Full Range
hours
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
OG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
OG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
OG003
Parsaclisib 20 mg QD
Secondary
Part 3: Cmin of Parsaclisib Monotherapy
Cmin is defined as the minimum observed plasma or serum concentration over the dose interval of parsaclisib. PK samples for parsaclisib monotherapy were collected and analyzed from the Part 3 dose expansion (different participant populations). Cohort A: B-cell malignancies; Cohort B: Hodgkin's lymphoma; Cohort C: diffuse large B-cell lymphoma; Cohort D: indolent lymphoma.
PK/PD Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
nmol
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
OG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
OG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
OG003
Parsaclisib 20 mg QD
Secondary
Part 3: AUC0-t of Parsaclisib Monotherapy
AUC0-t is defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t of of parsaclisib. PK samples for parsaclisib monotherapy were collected and analyzed from the Part 3 dose expansion (different participant populations). Cohort A: B-cell malignancies; Cohort B: Hodgkin's lymphoma; Cohort C: diffuse large B-cell lymphoma; Cohort D: indolent lymphoma.
PK/PD Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
hr*nmol/L
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
OG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
OG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
OG003
Secondary
Part 3: AUC0-τ of Parsaclisib Monotherapy
AUC0-τ is defined as the area under the steady-state plasma or serum concentration-time curve over 1 dose interval (i.e., from hour 0 to 12 for once every 12 hours [q12h] administration or from hour 0 to 24 for once every 24 hours [q24h] administration) of parsaclisib. PK samples for parsaclisib monotherapy were collected and analyzed from the Part 3 dose expansion (different participant populations). Cohort A: B-cell malignancies; Cohort B: Hodgkin's lymphoma; Cohort C: diffuse large B-cell lymphoma; Cohort D: indolent lymphoma.
PK/PD Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
hr*nmol/L
Cycle 1 Days 1 and 15; pre-dose and 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose
ID
Title
Description
OG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
OG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
OG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
Time Frame
Up to approximately 53 months (4.4 years)
Description
Treatment-emergent adverse events (TEAEs), defined as events that were reported for the first time, or the worsening of a pre-existing event, after the first dose of study drug, are reported for the Safety Population, defined as all participants enrolled in the study who received at least 1 dose of parsaclisib, itacitinib, rituximab, ifosfamide, carboplatin, and/or etoposide.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Parsaclisib 5 mg QD
Participants self-administered parsaclisib 5 milligrams (mg) as an oral tablet once a day (QD) in 21-day treatment cycles.
1
1
1
1
1
1
EG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
0
3
2
3
3
3
EG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
0
3
1
3
3
3
EG003
Parsaclisib 20 mg QD
Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles.
3
34
14
34
32
34
EG004
Parsaclisib 30 mg QD
Participants self-administered parsaclisib 30 mg as oral tablets QD in 21-day treatment cycles.
1
27
12
27
24
27
EG005
Parsaclisib 45 mg QD
Participants self-administered parsaclisib 45 mg as oral tablets QD in 21-day treatment cycles.
0
4
2
4
4
4
EG006
Parsaclisib 20 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 20 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
0
8
0
8
6
8
EG007
Parsaclisib 30 mg + Itacitinib 300 mg
Participants self-administered parsaclisib 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
0
3
2
3
3
3
EG008
Parsaclisib 15 mg QD + R-ICE
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 milligrams per meters squared (mg/m^2) intravenously (IV) on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin area under the curve (AUC) = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
0
4
1
4
4
4
EG009
Parsaclisib 20 mg QD + R-ICE
Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
0
1
1
1
1
1
EG010
Total
All participants in all treatment arms combined.
5
88
36
88
81
88
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0032 events2 affected34 at risk
EG0040 events0 affected27 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected1 at risk
EG0102 events2 affected88 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cytomegalovirus colitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis exfoliative
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastritis erosive
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Renal tubular necrosis
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected3 at risk
EG0030 events0 affected34 at risk
EG0041 events1 affected27 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected1 at risk
EG0104 events2 affected88 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood phosphorus increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Candida infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Device related infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eye irritation
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Genital discomfort
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Malaise
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Middle ear inflammation
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0014 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral swelling
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Polycythaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Radiculopathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory syncytial virus test positive
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Transaminases increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events2 affected3 at risk
EG0023 events1 affected3 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Visual perseveration
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Weight increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
White blood cell count increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Wound infection bacterial
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Wound infection pseudomonas
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
BG009NA± NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG01063.3± 14.44
BG002NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG00312
BG00414
BG005NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG006NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG007NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG008NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG009NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG01038
Male
Title
Measurements
BG000NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG001NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG002NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG00322
BG00413
BG005NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG006NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG007NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG008NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG009NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG01050
BG002NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG0034
BG0044
BG005NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG006NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG007NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG008NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG009NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG0109
White
Title
Measurements
BG000NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG001NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG002NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG00325
BG00421
BG005NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG006NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG007NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG008NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG009NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG01070
Unknown or Not Reported
Title
Measurements
BG000NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG001NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG002NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG0035
BG0042
BG005NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG006NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG007NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG008NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG009NADue to low participant enrollment in this arm, data are not being reported, as doing so may risk participant identification.
BG0109
34
OG00427
OG0054
OG0068
OG0073
OG0084
OG0091
32
OG00425
OG0054
OG0066
OG0073
OG0084
OG0091
OG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
OG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
OG003
Parsaclisib 20 mg QD
Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles.
OG004
Parsaclisib 30 mg QD
Participants self-administered parsaclisib 30 mg as oral tablets QD in 21-day treatment cycles.
OG005
Parsaclisib 45 mg QD
Participants self-administered parsaclisib 45 mg as oral tablets QD in 21-day treatment cycles.
Units
Counts
Participants
OG0000
OG0011
OG0020
OG0031
OG0043
OG0051
Title
Denominators
Categories
Title
Measurements
OG0010.0(0.0 to 97.5)
OG0030.0(0.0 to 97.5)
OG00466.7(9.4 to 99.2)
OG0050.0(0.0 to 97.5)
Participants self-administered parsaclisib 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
Units
Counts
Participants
OG0001
OG0010
Title
Denominators
Categories
Title
Measurements
OG000100.0(2.5 to 100.0)
OG001
Parsaclisib 20 mg QD + R-ICE
Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
Units
Counts
Participants
OG0000
OG0010
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
OG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
OG003
Parsaclisib 20 mg QD
Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles.
OG004
Parsaclisib 30 mg QD
Participants self-administered parsaclisib 30 mg as oral tablets QD in 21-day treatment cycles.
OG005
Parsaclisib 45 mg QD
Participants self-administered parsaclisib 45 mg as oral tablets QD in 21-day treatment cycles.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG003100.0(2.5 to 100.0)
Participants self-administered parsaclisib 30 mg as oral tablets QD and itacitinib 300 mg as oral tablets QD in 21-day treatment cycles.
Units
Counts
Participants
OG0000
OG0010
OG001
Parsaclisib 20 mg QD + R-ICE
Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
Units
Counts
Participants
OG0000
OG0010
OG001
Parsaclisib 10 mg QD
Participants self-administered parsaclisib 10 mg as oral tablets QD in 21-day treatment cycles.
OG002
Parsaclisib 15 mg QD
Participants self-administered parsaclisib 15 mg as oral tablets QD in 21-day treatment cycles.
OG003
Parsaclisib 20 mg QD
Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles.
OG004
Parsaclisib 30 mg QD
Participants self-administered parsaclisib 30 mg as oral tablets QD in 21-day treatment cycles.
OG005
Parsaclisib 45 mg QD
Participants self-administered parsaclisib 45 mg as oral tablets QD in 21-day treatment cycles.
Units
Counts
Participants
OG0001
OG0012
OG0023
OG00332
OG00424
OG0053
Title
Denominators
Categories
Diffuse large B-cell lymphoma
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG00311
ParticipantsOG0046
ParticipantsOG0052
Title
Measurements
OG0000.0(0.0 to 97.5)
OG0010.0(0.0 to 97.5)
OG00250.0(1.3 to 98.7)
OG003
Follicular lymphoma
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0037
Mantle cell lymphoma
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0036
Marginal zone lymphoma
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Extranodal marginal zone lymphoma of mucosa-associated lymphatic tissue
Participants self-administered parsaclisib 20 mg as oral tablets QD in 21-day treatment cycles. R-ICE was a standard-of-care chemotherapy combination administered at the following doses: rituximab 375 mg/m^2 IV on Day 1 and Day 2 of Cycle 1 and on Day 1 of Cycles 2 and 3, ifosfamide 5000 mg/m^2 IV on Day 3 of each cycle, carboplatin AUC = 5 (maximum dose 800 mg) IV on Day 3 of each cycle, and etoposide 100 mg/m^2 or at doses consistent with institutional practice with approval from the medical monitor on Days 3 and 5 of each cycle. Each cycle was 21 days in duration.
Units
Counts
Participants
OG0004
OG0011
Title
Denominators
Categories
Diffuse large B-cell lymphoma
ParticipantsOG0004
ParticipantsOG0011
Title
Measurements
OG00050.0(NA to NA)Summary statistics are not available due to the small sample size in Part 6.
OG001100.0(NA to NA)Summary statistics are not available due to the small sample size in Part 6.
Follicular lymphoma
ParticipantsOG0000
ParticipantsOG0010
Mantle cell lymphoma
ParticipantsOG0000
ParticipantsOG0010
Marginal zone lymphoma
ParticipantsOG0000
ParticipantsOG0010
Extranodal marginal zone lymphoma of mucosa-associated lymphatic tissue