Rovalpituzumab Tesirine (SC16LD6.5) in Recurrent Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT01901653 |
Recruitment Status :
Completed
First Posted : July 17, 2013
Results First Posted : July 11, 2018
Last Update Posted : August 9, 2018
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Sponsor:
Stemcentrx
Information provided by (Responsible Party):
Stemcentrx
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Recurrent Small Cell Lung Cancer |
Intervention |
Drug: Rovalpituzumab tesirine (SC16LD6.5) |
Enrollment | 82 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Phase 1a: Cohort 1 Small Cell Lung Cancer (SCLC) | Phase 1a: Cohort 2 (SCLC) | Phase 1a: Cohort 3 (SCLC) | Phase 1a: Cohort 4 (SCLC) | Phase 1a: Cohort 5 (SCLC) | Phase 1a: Cohort 6 (SCLC) | Phase 1a: Cohort 7 (SCLC) | Phase 1a: Cohort 8 (SCLC) | Phase 1a: Cohort 8 Large Cell Neuroendocrine Carcinoma (LCNEC) | Phase 1b: Retreatment (SCLC) | Phase 1b: Retreatment (LCNEC) | Phase 1b: Maintenance (SCLC) | Phase 1b: Maintenance (LCNEC) |
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Arm/Group Description | SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle | SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle | SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle | SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle | SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle | SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle | SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle | SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle | LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle | 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. | 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. | 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 | 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 |
Period Title: Overall Study | |||||||||||||
Started | 3 | 1 | 11 | 3 | 2 | 3 | 7 | 10 | 1 | 18 | 2 | 16 | 5 |
Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Not Completed | 3 | 1 | 11 | 3 | 2 | 3 | 7 | 10 | 1 | 18 | 2 | 16 | 5 |
Reason Not Completed | |||||||||||||
Death | 2 | 1 | 8 | 3 | 2 | 2 | 6 | 9 | 1 | 16 | 2 | 15 | 4 |
Lost to Follow-up | 1 | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Alive at Study Termination by Sponsor | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 1 |
Baseline Characteristics
Arm/Group Title | Phase 1a: Cohort 1 (SCLC) | Phase 1a: Cohort 2 (SCLC) | Phase 1a: Cohort 3 (SCLC) | Phase 1a: Cohort 4 (SCLC) | Phase 1a: Cohort 5 (SCLC) | Phase 1a: Cohort 6 (SCLC) | Phase 1a: Cohort 7 (SCLC) | Phase 1a: Cohort 8 (SCLC) | Phase 1a: Cohort 8 (LCNEC) | Phase 1b: Retreatment (SCLC) | Phase 1b: Retreatment (LCNEC) | Phase 1b: Maintenance (SCLC) | Phase 1b: Maintenance (LCNEC) | Total | |
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Arm/Group Description | SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle | SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle | SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle | SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle | SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle | SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle | SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle | SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle | LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle | 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. | 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. | 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 | 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 | Total of all reporting groups | |
Overall Number of Baseline Participants | 3 | 1 | 11 | 3 | 2 | 3 | 7 | 10 | 1 | 18 | 2 | 16 | 5 | 82 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | 1 participants | 11 participants | 3 participants | 2 participants | 3 participants | 7 participants | 10 participants | 1 participants | 18 participants | 2 participants | 16 participants | 5 participants | 82 participants | |
<=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Between 18 and 65 years | 3 | 1 | 6 | 2 | 2 | 1 | 5 | 7 | 1 | 11 | 1 | 9 | 2 | 51 | |
>=65 years | 0 | 0 | 5 | 1 | 0 | 2 | 2 | 3 | 0 | 7 | 1 | 7 | 3 | 31 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | 1 participants | 11 participants | 3 participants | 2 participants | 3 participants | 7 participants | 10 participants | 1 participants | 18 participants | 2 participants | 16 participants | 5 participants | 82 participants | |
Female | 2 | 1 | 4 | 2 | 1 | 1 | 2 | 4 | 0 | 11 | 0 | 4 | 2 | 34 | |
Male | 1 | 0 | 7 | 1 | 1 | 2 | 5 | 6 | 1 | 7 | 2 | 12 | 3 | 48 | |
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | 1 participants | 11 participants | 3 participants | 2 participants | 3 participants | 7 participants | 10 participants | 1 participants | 18 participants | 2 participants | 16 participants | 5 participants | 82 participants | |
Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | |
Not Hispanic or Latino | 3 | 1 | 10 | 3 | 2 | 3 | 7 | 10 | 1 | 14 | 2 | 15 | 4 | 75 | |
Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 1 | 6 | |
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | 1 participants | 11 participants | 3 participants | 2 participants | 3 participants | 7 participants | 10 participants | 1 participants | 18 participants | 2 participants | 16 participants | 5 participants | 82 participants | |
American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Asian | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | |
Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Black or African American | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | |
White | 3 | 1 | 10 | 2 | 2 | 2 | 5 | 10 | 1 | 15 | 2 | 15 | 3 | 71 | |
More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | |
Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 1 | 5 | |
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 3 participants | 1 participants | 11 participants | 3 participants | 2 participants | 3 participants | 7 participants | 10 participants | 1 participants | 18 participants | 2 participants | 16 participants | 5 participants | 82 participants |
3 | 1 | 11 | 3 | 2 | 3 | 7 | 10 | 1 | 18 | 2 | 16 | 5 | 82 | ||
Eastern Cooperative Oncology Group (ECOG) Performance Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | 1 participants | 11 participants | 3 participants | 2 participants | 3 participants | 7 participants | 10 participants | 1 participants | 18 participants | 2 participants | 16 participants | 5 participants | 82 participants | |
0 | 2 | 0 | 4 | 2 | 1 | 1 | 0 | 3 | 0 | 3 | 1 | 5 | 1 | 23 | |
1 | 1 | 1 | 7 | 1 | 1 | 2 | 6 | 7 | 1 | 13 | 1 | 11 | 3 | 55 | |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 1 | 4 | |
[1]
Measure Description: 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.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: | Senior Director, Clinical Operations |
Organization: | AbbVie Stemcentrx |
Phone: | (650) 827-4879 |
EMail: | isobel.lakatos@abbvie.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Stemcentrx |
ClinicalTrials.gov Identifier: | NCT01901653 |
Other Study ID Numbers: |
SCRX16-001 |
First Submitted: | July 11, 2013 |
First Posted: | July 17, 2013 |
Results First Submitted: | February 6, 2018 |
Results First Posted: | July 11, 2018 |
Last Update Posted: | August 9, 2018 |