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The purpose of this study is to assess the safety and tolerability of rovalpituzumab tesirine (SC16LD6.5) at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard chemotherapy. Once a safe and tolerable dose is determined, the anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a protein that appears to be expressed on the surface of most small cell lung cancers that have been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of chemotherapy, specifically a DNA-damaging agent, that is cell cycle independent. ADC's theoretically provide more precise delivery of chemotherapy to cancer cells, possibly improving effectiveness relative to toxicities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rovalpituzumab tesirine | Experimental | Rovalpituzumab tesirine will be administered as a single agent, at increasing dose levels as permitted based on real-time assessment of safety and tolerability, intravenously over 30 minutes. Doses will be repeated on Day 1 of each 21-day or 42-day cycle until either unacceptable toxicity or evidence of disease progression occurs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rovalpituzumab tesirine (SC16LD6.5) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Rovalpituzumab Tesirine | MTD was determined by testing increasing doses from 0.05 mg/kg up to 0.8 mg/kg on Day 1 of every 21-day or 42-day cycle, Phase 1a cohorts 1 to 8. MTD will be defined as the dose level immediately below the dose level at which ≥ 2 of the first 3 subjects per cohort (or ≥ 2 of 6 subjects) during the first cycle experience a study drug related dose limiting toxicity (DLT). | The DLT period was defined as either 21 or 42 days following the first dose of Rovalpituzumab tesirine during dose escalation (Phase 1a), depending on Cycle length. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Overall response was assessed at each visit post-baseline based on a subject's lesion measurements or assessments (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], or not evaluable as defined by RECIST v1.1, plus an additional category of early death). The best overall response was then determined. A subject was defined as having an objective response if they had a best overall response of CR or PR prior to receiving any subsequent anticancer therapy; confirmed response is confirmation of CR or PR at least 4 weeks from the initial determination per RECIST v1.1. Subjects with a post-baseline assessment were included in the calculations for objective response rate (ORR). Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC). |
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Inclusion Criteria
Provision of informed consent
Male or female ≥18 years of age
Histologic or cytologic confirmed diagnosis of small cell lung cancer, either limited or extensive disease at initial presentation is allowed
Evidence of progressive disease during or following 1 or 2 prior chemotherapy regimens
Measurable disease (only for the phase II portion)
Eastern Cooperative Oncology Group (ECOG) Performance status 0-1
A minimum life expectancy of 12 weeks
Adequate bone marrow, hepatic and renal function as evidenced by:
No 'active' CNS metastases. Prior CNS metastases are allowed, provided adequate palliative therapy has been administered and CNS disease control has been established prior to study entry.
• A brain MRI scan, ≤ 28 days from day 1, is required
Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures and who have a negative serum pregnancy test within 1 week prior to initial study treatment. (See Appendix B)
Male patients willing to use adequate contraceptive. (See Appendix B)
At least 21 days must have elapsed prior to day 1 cycle 1, from chemotherapy, radiotherapy, immunotherapy or following major surgery and any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 for "limited palliative radiotherapy", defined as a course of therapy encompassing < 25% total bone marrow volume and not exceeding 30 Gy.
At least 14 days must have elapsed for chemotherapy regimens, biologic, and targeted therapy given continuously or on a weekly basis with limited potential for delayed toxicity.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Strickland, MD | SCRI Innovations | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Florida Cancer Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27932068 | Derived | Rudin CM, Pietanza MC, Bauer TM, Ready N, Morgensztern D, Glisson BS, Byers LA, Johnson ML, Burris HA 3rd, Robert F, Han TH, Bheddah S, Theiss N, Watson S, Mathur D, Vennapusa B, Zayed H, Lally S, Strickland DK, Govindan R, Dylla SJ, Peng SL, Spigel DR; SCRX16-001 investigators. Rovalpituzumab tesirine, a DLL3-targeted antibody-drug conjugate, in recurrent small-cell lung cancer: a first-in-human, first-in-class, open-label, phase 1 study. Lancet Oncol. 2017 Jan;18(1):42-51. doi: 10.1016/S1470-2045(16)30565-4. Epub 2016 Dec 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1a: Cohort 1 Small Cell Lung Cancer (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle |
| FG001 | Phase 1a: Cohort 2 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle |
| FG002 | Phase 1a: Cohort 3 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle |
| FG003 | Phase 1a: Cohort 4 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle |
| FG004 | Phase 1a: Cohort 5 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle |
| FG005 | Phase 1a: Cohort 6 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle |
| FG006 | Phase 1a: Cohort 7 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle |
| FG007 | Phase 1a: Cohort 8 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle |
| FG008 | Phase 1a: Cohort 8 Large Cell Neuroendocrine Carcinoma (LCNEC) | LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle |
| FG009 | Phase 1b: Retreatment (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. |
| FG010 | Phase 1b: Retreatment (LCNEC) | LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. |
| FG011 | Phase 1b: Maintenance (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle |
| FG012 | Phase 1b: Maintenance (LCNEC) | LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1a: Cohort 1 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle |
| BG001 | Phase 1a: Cohort 2 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Maximum Tolerated Dose (MTD) of Rovalpituzumab Tesirine | MTD was determined by testing increasing doses from 0.05 mg/kg up to 0.8 mg/kg on Day 1 of every 21-day or 42-day cycle, Phase 1a cohorts 1 to 8. MTD will be defined as the dose level immediately below the dose level at which ≥ 2 of the first 3 subjects per cohort (or ≥ 2 of 6 subjects) during the first cycle experience a study drug related dose limiting toxicity (DLT). | All subjects from Phase 1a Dose Escalation: Cohort 1 to 8 who received at least 1 dose of study drug. | Posted | Number | mg/kg | The DLT period was defined as either 21 or 42 days following the first dose of Rovalpituzumab tesirine during dose escalation (Phase 1a), depending on Cycle length. |
|
From date of first dose through 30-days following last dose (on average 85 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1a: Cohort 1 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical Operations | AbbVie Stemcentrx | (650) 827-4879 | isobel.lakatos@abbvie.com |
Not provided
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000620223 | rovalpituzumab tesirine |
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| From first dose of rovalpituzumab tesirine to last event, up through study completion (on average approximately 4 months). |
| Duration of Response (DOR) | Duration of response (DOR) was defined as the number of months from the initial CR or PR to the time of disease progression or death, whichever occurred first. Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC). | From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on average approximately 4 months, but up to 6.51 months). |
| Clinical Benefit Rate (CBR) | Clinical Benefit is defined as a subject with best Overall Response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) prior to receiving any subsequent anticancer therapy; as defined by RECIST version 1.1. CBR is defined as the proportion of subjects with Clinical Benefit based on assessment of overall response. CBR will be presented as a number and percentage with 95% confidence bounds. Any subjects not exhibiting a response (CR or PR or SD) are considered non-responders. Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC). | From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on avergae approximately 4 months). |
| Progression-free Survival (PFS) | Progression-free survival (PFS) was defined as the number of months from the first day of study drug administration to disease recurrence or progression, or death on study. Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC). | From first dose of rovalpituzumab tesirine to last event timepoint, up through study completion (approximately 4 months on average, but up to 14.46 months). |
| Overall Survival | Overall survival (OS) was defined as the time from the first day of study treatment to death. Subjects who were alive were censored at the date of last known alive. | From first dose of Rovalpituzumab tesirine to last event, up through study completion (on average approximately 5-7 months, but up to 14.6 months). |
| Maximum Serum Concentration (Cmax) of Rovalpituzumab Tesirine Antibody Drug Conjugate (ADC) | The maximum serum concentration (Cmax; measured in μg/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing cycle. | From Day 1 of first dose to End of Dose Cycle |
| Area Under the Serum Concentration-time Curve (AUC) of Rovalpituzumab Tesirine ADC | The area under the serum concentration-time curve (AUC; measured in μg•d/mL) is a method of measurement to determine the total exposure of a drug in blood serum. | From Day 1 of first dose to End of Dose Cycle |
| Sarasota |
| Florida |
| 34232 |
| United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | United States |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Alive at Study Termination by Sponsor |
|
| BG002 | Phase 1a: Cohort 3 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle |
| BG003 | Phase 1a: Cohort 4 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle |
| BG004 | Phase 1a: Cohort 5 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle |
| BG005 | Phase 1a: Cohort 6 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle |
| BG006 | Phase 1a: Cohort 7 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle |
| BG007 | Phase 1a: Cohort 8 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle |
| BG008 | Phase 1a: Cohort 8 (LCNEC) | LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle |
| BG009 | Phase 1b: Retreatment (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. |
| BG010 | Phase 1b: Retreatment (LCNEC) | LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. |
| BG011 | Phase 1b: Maintenance (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle |
| BG012 | Phase 1b: Maintenance (LCNEC) | LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle |
| BG013 | Total | Total of all reporting groups |
| Participants |
| No |
|
| 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 | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOGScale:Score-Description:0-Normalactivity.Fullyactive,abletocarryonallprediseaseperformancew/orestriction/1-Symptoms,but ambulatory.Restrictedinphysicallystrenuousactivity,butambulatoryandabletocarryoutworkofa light/sedentarynature(eg,light housework,office work)/2-In bed<50%ofthetime.Ambulatoryandcapableofallselfcare,but unabletocarryoutanyworkactivities.Upandabout>50%ofwakinghours/3-In bed>50%ofthetime.Capableofonlylimitedselfcare,confinedtobed/chair>50%ofwakinghours/4-100% bedridden.Completelydisabled.Cannotcarryonanyselfcare.Totallyconfinedtobed/chair/5-Dead. | Count of Participants | Participants | No |
|
|
|
| Secondary | Objective Response Rate (ORR) | Overall response was assessed at each visit post-baseline based on a subject's lesion measurements or assessments (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], or not evaluable as defined by RECIST v1.1, plus an additional category of early death). The best overall response was then determined. A subject was defined as having an objective response if they had a best overall response of CR or PR prior to receiving any subsequent anticancer therapy; confirmed response is confirmation of CR or PR at least 4 weeks from the initial determination per RECIST v1.1. Subjects with a post-baseline assessment were included in the calculations for objective response rate (ORR). Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC). | Subjects with at least one post-dose assessment. All LCNEC subjects were analyzed. No LCNEC subjects achieved CR or PR and, therefore, the ORR was 0%. | Posted | Number | 95% Confidence Interval | percentage of subjects | From first dose of rovalpituzumab tesirine to last event, up through study completion (on average approximately 4 months). |
|
|
|
| Secondary | Duration of Response (DOR) | Duration of response (DOR) was defined as the number of months from the initial CR or PR to the time of disease progression or death, whichever occurred first. Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC). | Subjects with at least one post-dose assessment. No LCNEC subjects achieved CR or PR, therefore DOR was not analyzed. | Posted | Median | 95% Confidence Interval | months | From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on average approximately 4 months, but up to 6.51 months). |
|
|
|
| Secondary | Clinical Benefit Rate (CBR) | Clinical Benefit is defined as a subject with best Overall Response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) prior to receiving any subsequent anticancer therapy; as defined by RECIST version 1.1. CBR is defined as the proportion of subjects with Clinical Benefit based on assessment of overall response. CBR will be presented as a number and percentage with 95% confidence bounds. Any subjects not exhibiting a response (CR or PR or SD) are considered non-responders. Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC). | Subjects with at least one post-dose assessment. | Posted | Number | 95% Confidence Interval | percentage of subjects | From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on avergae approximately 4 months). |
|
|
|
| Secondary | Progression-free Survival (PFS) | Progression-free survival (PFS) was defined as the number of months from the first day of study drug administration to disease recurrence or progression, or death on study. Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC). | Subjects with at least one post-dose assessment. | Posted | Median | 95% Confidence Interval | months | From first dose of rovalpituzumab tesirine to last event timepoint, up through study completion (approximately 4 months on average, but up to 14.46 months). |
|
|
|
| Secondary | Overall Survival | Overall survival (OS) was defined as the time from the first day of study treatment to death. Subjects who were alive were censored at the date of last known alive. | Subjects with at least one post-dose assessment. | Posted | Median | 95% Confidence Interval | months | From first dose of Rovalpituzumab tesirine to last event, up through study completion (on average approximately 5-7 months, but up to 14.6 months). |
|
|
|
| Secondary | Maximum Serum Concentration (Cmax) of Rovalpituzumab Tesirine Antibody Drug Conjugate (ADC) | The maximum serum concentration (Cmax; measured in μg/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing cycle. | All subjects who received at least 1 dose of study drug, with evaluable data at each given timepoint. For Phase 1b, pharmacokinetic (PK) sampling was sparse; therefore, pharmacokinetic parameters were not estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | From Day 1 of first dose to End of Dose Cycle |
|
|
|
| Secondary | Area Under the Serum Concentration-time Curve (AUC) of Rovalpituzumab Tesirine ADC | The area under the serum concentration-time curve (AUC; measured in μg•d/mL) is a method of measurement to determine the total exposure of a drug in blood serum. | All subjects who received at least 1 dose of study drug, with evaluable data at each given timepoint. For Phase 1b, pharmacokinetic (PK) sampling was sparse; therefore, pharmacokinetic parameters were not estimated. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg•d/mL | From Day 1 of first dose to End of Dose Cycle |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Phase 1a: Cohort 2 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle | 0 | 1 | 1 | 1 |
| EG002 | Phase 1a: Cohort 3 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle | 3 | 11 | 11 | 11 |
| EG003 | Phase 1a: Cohort 4 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle | 3 | 3 | 3 | 3 |
| EG004 | Phase 1a: Cohort 5 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle | 2 | 2 | 2 | 2 |
| EG005 | Phase 1a: Cohort 6 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle | 2 | 3 | 3 | 3 |
| EG006 | Phase 1a: Cohort 7 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle | 1 | 7 | 7 | 7 |
| EG007 | Phase 1a: Cohort 8 (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle | 4 | 10 | 10 | 10 |
| EG008 | Phase 1a: Cohort 8 (LCNEC) | LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle | 1 | 1 | 1 | 1 |
| EG009 | Phase 1b: Retreatment (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. | 7 | 18 | 18 | 18 |
| EG010 | Phase 1b: Retreatment (LCNEC) | LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. | 1 | 2 | 2 | 2 |
| EG011 | Phase 1b: Maintenance (SCLC) | SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle | 5 | 16 | 15 | 16 |
| EG012 | Phase 1b: Maintenance (LCNEC) | LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle | 4 | 5 | 5 | 5 |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Cardiac Tamponade | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Anal Fistula | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Bile Duct Stenosis | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Liver Function Test Abnormal | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Blood Alkaline Phosphatase Increase | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Tumor Haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
|
| Cauda Equina Syndrome | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Confusional State | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Psychotic Disorder | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
| Capillary Leak Syndrome | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
|
| Sinus Tachycardia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA (19.1) | Systematic Assessment |
|
| Periorbital Oedema | Eye disorders | MedDRA (19.1) | Systematic Assessment |
|
| Lacrimation Increased | Eye disorders | MedDRA (19.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Face Oedema | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Lipase Increased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Amylase Increased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Blood Albumin Decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Weight Increased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Confusional State | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Photosensitivity Reaction | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Erythema Multiforme | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Skin Exfoliation | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Swelling Face | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| ORR unconfirmed by IRC |
|
| ORR confirmed by IRC |
|
| CBR unconfirmed by IRC |
|
| CBR confirmed by IRC |
|