Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J1C-MC-JZDA | Other Identifier | Eli Lilly and Company | |
| 2018-001598-25 | EudraCT Number |
Not provided
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The study was terminated during dose escalation after a determination was made that the risk:benefit ratio no longer favored continued evaluation.
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The goal of this study is to evaluate the safety of LY3415244, a PD-L1/TIM-3 bispecific antibody, administered as monotherapy to participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3415244 Dose Escalation | Experimental | Participants received 3 milligrams (mg) LY3415244 (Cohort A1), 10 mg LY3415244 (Cohort A2), 30 mg LY3415244 (Cohort A3) and 70 mg LY3415244 (Cohort A4) as an intravenous (IV) infusion on day (D)1 and D15 of each 28-day cycle every 2 weeks (Q2W). |
|
| LY3415244 Dose Expansion | Experimental | Phase 1b dose expansion was planned but not initiated as dose escalation ended at cohort A4. Study did not achieve its primary objective of establishing a recommended phase 2 dose (RP2D) due to early termination of the study by Cohort A4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3415244 | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase1a: Number of Participants With LY3415244 Dose-Limiting Toxicities (DLTs) | A DLT was defined as an adverse event (AE) occurring during Cycle 1(28 days) that was considered at least possibly related to study drug, was considered dose-dependent, and fulfilled a criteria selected (using the National Cancer Institute Common Terminology Criteria for Adverse Events,version 4.0 [NCI-CTCAE v 4.0] [NCI 2009]):Grade 3 thrombocytopenia requiring platelet transfusion or grade 4 thrombocytopenia. Grade greater than or equal to (≥) 3 febrile neutropenia, anemia requiring a blood transfusion and any other Grade 4 hematologic toxicity that last >7 days. Grade ≥ 3 colitis or noninfectious pneumonitis, Grade ≥ 3 fatigue lasting >7 days, Grade ≥ 3 hypertension despite of maximal medical therapy. Grade 4 immune-related adverse event (irAE), liver transaminase elevation >8x upper limit of normal (ULN) or total bilirubin >3x ULN. | Baseline through Cycle 1 (28 Day Cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase1a: Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3415244 | Cmin of LY3415244 was evaluated. | Cycle 1 Day 1 (C1D1) and C1D15: pre-dose, 2 hours(h), 4h, 24h, 72h, 120h and 168h post-dose; C2D1, C2D15, C3D1, C3D15, C4D1, C4D15, C5D1, C5D15, C6D1 and C6D15: pre-dose |
| Phase1b: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) |
Not provided
Inclusion Criteria:
For Phase 1a/b, histologic or cytologic confirmation of advanced solid tumor.
For Phase 1a/b, biopsy of tumor samples are required. Newly obtained core or excisional biopsy of a tumor lesion prior to study enrollment and undergo a biopsy procedure during the study.
Phase 1a, prior anti-PD-1 or anti-PD-L1 therapy or other immunotherapy is allowed.
Phase 1b, prior anti-PD-1 or anti-PD-L1 therapy is required where anti-PD-1 or anti-PD-L1 is standard of care in respective tumor types if the following criteria are met:
Must have at least 1 measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Have adequate organ function.
Have an estimated life expectancy ≥12 weeks, in the judgement of the investigator.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Memorial Sloan Kettering Cancer Center |
Not provided
| Label | URL |
|---|---|
| A Study of LY3415244 in Participants With Advanced Solid Tumors | View source |
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Phase 1a of study consisted of dose-escalation assessment and Phase 1b of study included dose expansion. Four out of planned eight cohorts (one optional) in Phase 1a were completed. Phase 1b dose expansion was planned but not initiated as dose escalation ended at cohort A4.A participant completed study if they completed at least 1 cycle (28 days).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A1 | Participants received 3 milligrams (mg) LY3415244 as an intravenous (IV) infusion on day (D)1 and D15 of each 28-day cycle every 2 weeks (Q2W). |
| FG001 | Cohort A2 | Participants received 10 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W. |
| FG002 | Cohort A3 | Participants received 30 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W. |
| FG003 | Cohort A4 | Participants received 70 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A1 | Participants received 3 milligrams (mg) LY3415244 as an intravenous (IV) infusion on day (D)1 and D15 of each 28-day cycle every 2 weeks (Q2W). |
| BG001 | Cohort A2 | Participants received 10 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Phase1a: Number of Participants With LY3415244 Dose-Limiting Toxicities (DLTs) | A DLT was defined as an adverse event (AE) occurring during Cycle 1(28 days) that was considered at least possibly related to study drug, was considered dose-dependent, and fulfilled a criteria selected (using the National Cancer Institute Common Terminology Criteria for Adverse Events,version 4.0 [NCI-CTCAE v 4.0] [NCI 2009]):Grade 3 thrombocytopenia requiring platelet transfusion or grade 4 thrombocytopenia. Grade greater than or equal to (≥) 3 febrile neutropenia, anemia requiring a blood transfusion and any other Grade 4 hematologic toxicity that last >7 days. Grade ≥ 3 colitis or noninfectious pneumonitis, Grade ≥ 3 fatigue lasting >7 days, Grade ≥ 3 hypertension despite of maximal medical therapy. Grade 4 immune-related adverse event (irAE), liver transaminase elevation >8x upper limit of normal (ULN) or total bilirubin >3x ULN. | All participants who received at least 1 dose of study drug and had evaluable DLT data. | Posted | Count of Participants | Participants | No | Baseline through Cycle 1 (28 Day Cycle) |
|
Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A1 | Participants received 3 milligrams (mg) LY3415244 as an intravenous (IV) infusion on day (D)1 and D15 of each 28-day cycle every 2 weeks (Q2W). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
Phase 1b dose expansion was planned but not initiated as dose escalation ended at cohort A4. Study did not achieve its primary objective of establishing a recommended phase 2 dose (RP2D) due to early termination of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 13, 2018 | May 18, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 24, 2018 | May 18, 2020 | SAP_001.pdf |
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ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. |
| Baseline through Measured Progressive Disease (Up To 24 Months) |
| Phase1b: Duration of Response (DoR) | Duration of response was defined using RECIST v. 1.1 criteria as the time from the date criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death from any cause. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to <10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy. | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 24 Months) |
| Phase1b: Time to Response (TTR) | Data were not captured as study was terminated early and no participant were enrolled into Phase 1b expansion. Time to treatment response was defined as date of first dose of study drug to the date of confirmed complete response (CR) or partial response (PR) using Response evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker levels in non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. | Baseline to Date of CR or PR (Up To 24 Months) |
| Phase1b: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease | DCR is the percentage of participants with a best overall response of CR, PR or stable disease (SD) as defined by RECIST v1.1. CR is defined as disappearance of all target and non-target lesions and no appearance of new lesions.PR is defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions (taking as reference the baseline sum LD),no progression of non-target lesions, and no appearance of new lesions.SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm,or unequivocal progression of non-target lesions,or 1 or more new lesions. | Baseline through Measured Progressive Disease (Up To 24 Months) |
| Phase1b: Progression Free Survival (PFS) | Progression-free survival time was measured from treatment start until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Patients who have neither progressed nor died were censored at the day of their last radiographic tumor assessment, if available, or date of treatment start if no post-baseline radiographic assessment is available. | Baseline to Objective Progression or Death Due to Any Cause (Up To 24 Months) |
| New York |
| New York |
| 10065 |
| United States |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277 8577 | Japan |
| National Cancer Center Hospital | Chuo-Ku | Tokyo | 104-0045 | Japan |
| BG002 | Cohort A3 | Participants received 30 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W. |
| BG003 | Cohort A4 | Participants received 70 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG000 | Cohort A1 | Participants received 3 milligrams (mg) LY3415244 as an intravenous (IV) infusion on day (D)1 and D15 of each 28-day cycle every 2 weeks (Q2W). |
| OG001 | Cohort A2 | Participants received 10 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W. |
| OG002 | Cohort A3 | Participants received 30 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W. |
| OG003 | Cohort A4 | Participants received 70 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W. |
|
|
| Secondary | Phase1a: Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3415244 | Cmin of LY3415244 was evaluated. | All participants who received at least 1 dose of study drug with evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Cycle 1 Day 1 (C1D1) and C1D15: pre-dose, 2 hours(h), 4h, 24h, 72h, 120h and 168h post-dose; C2D1, C2D15, C3D1, C3D15, C4D1, C4D15, C5D1, C5D15, C6D1 and C6D15: pre-dose |
|
|
|
| Secondary | Phase1b: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | Zero participants were analyzed for this outcome. Data were not captured as study was terminated early and no participant were enrolled into Phase 1b expansion. | Posted | Baseline through Measured Progressive Disease (Up To 24 Months) |
|
|
| Secondary | Phase1b: Duration of Response (DoR) | Duration of response was defined using RECIST v. 1.1 criteria as the time from the date criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death from any cause. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to <10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy. | Zero participants were analyzed for this outcome. Data were not captured as study was terminated early and no participant were enrolled into Phase 1b expansion. | Posted | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 24 Months) |
|
|
| Secondary | Phase1b: Time to Response (TTR) | Data were not captured as study was terminated early and no participant were enrolled into Phase 1b expansion. Time to treatment response was defined as date of first dose of study drug to the date of confirmed complete response (CR) or partial response (PR) using Response evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker levels in non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. | Zero participants were analyzed for this outcome. Data were not captured as study was terminated early and no participant were enrolled into Phase 1b expansion. | Posted | Baseline to Date of CR or PR (Up To 24 Months) |
|
|
| Secondary | Phase1b: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease | DCR is the percentage of participants with a best overall response of CR, PR or stable disease (SD) as defined by RECIST v1.1. CR is defined as disappearance of all target and non-target lesions and no appearance of new lesions.PR is defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions (taking as reference the baseline sum LD),no progression of non-target lesions, and no appearance of new lesions.SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm,or unequivocal progression of non-target lesions,or 1 or more new lesions. | Zero participants were analyzed for this outcome. Data were not captured as study was terminated early and no participant were enrolled into Phase 1b expansion. | Posted | Baseline through Measured Progressive Disease (Up To 24 Months) |
|
|
| Secondary | Phase1b: Progression Free Survival (PFS) | Progression-free survival time was measured from treatment start until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Patients who have neither progressed nor died were censored at the day of their last radiographic tumor assessment, if available, or date of treatment start if no post-baseline radiographic assessment is available. | Zero participants were analyzed for this outcome. Data were not captured as study was terminated early and no participant were enrolled into Phase 1b expansion. | Posted | Baseline to Objective Progression or Death Due to Any Cause (Up To 24 Months) |
|
|
| 2 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Cohort A2 | Participants received 10 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Cohort A3 | Participants received 30 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Cohort A4 | Participants received 70 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W. | 0 | 3 | 2 | 3 | 3 | 3 |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eye movement disorder | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Blood creatinine decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Polydipsia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
PI must delay publications until a multi-center publication is disclosed, (or for a time period if no multi-center publication is disclosed).
|
| Cycle 1 Day 15 |
|
|