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NCT01638546 · ClinicalTrials.gov registry record · Phase 2
Temozolomide With or Without Veliparib in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
A Phase 2 study of Recurrent Lung Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
- 14
- Study locations
NCT01638546: Active Phase 2 study of Recurrent Lung Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).
NCT01638546 is a Phase 2 study of Recurrent Lung Small Cell Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 97 participants, below the 108-participant average among 5 other Recurrent Lung Small Cell Carcinoma trials with a reported enrollment target (10% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01638546, a Phase 2 study of Recurrent Lung Small Cell Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
- 14
- Study locations
Study Summary
This randomized phase II trial studies how well temozolomide with or without veliparib works in treating patients with small cell lung cancer that has returned or does not respond to treatment. Temozolomide works by damaging molecules inside the cancer cells, such as deoxyribonucleic acid (DNA), that are needed for cancer survival and growth. Veliparib may stop the growth of tumor cells by blocking proteins that are needed for repairing the damaged DNA and it may also help temozolomide to kill more cancer cells. It is not yet know whether temozolomide is more effective with or without veliparib in treating patients with relapsed or refractory small cell lung cancer.
Primary Outcome
Compared across the two arms using a Fisher exact test.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Temozolomide
- OTHER Placebo Administration
- DRUG Veliparib
Study Locations (14)
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Sleepy Hollow - Sleepy Hollow
- Memorial Sloan Kettering Nassau - Uniondale
Maryland
- Johns Hopkins Bayview Medical Center - Baltimore
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Missouri
- Washington University School of Medicine - St Louis
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Ohio
- Case Western Reserve University - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2012-07-27 |
| Est. Completion | 2026-03-25 |
| Phase | Phase 2 |
What the registry record for NCT01638546 still lists
NCT01638546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 108-participant average among 5 other Recurrent Lung Small Cell Carcinoma trials with a reported enrollment target (10% lower).
The record links to 1 condition, with Recurrent Lung Small Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01638546 lists 14 locations in 10 states (New York, Maryland, Florida).
Frequently Asked Questions
What is clinical trial NCT01638546 about?
NCT01638546 is a clinical study titled "Temozolomide With or Without Veliparib in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer". This randomized phase II trial studies how well temozolomide with or without veliparib works in treating patients with small cell lung cancer that has returned or does not respond to treatment. Temozolomide works by damaging molecules inside the cancer cells, such as deoxyribonucleic acid (DNA), tha...
What is the current status of trial NCT01638546?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2012-07-27. Estimated completion is 2026-03-25.
What conditions does trial NCT01638546 study?
This clinical trial studies the following conditions: Recurrent Lung Small Cell Carcinoma.
What interventions are being tested in trial NCT01638546?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Temozolomide (DRUG), Placebo Administration (OTHER), Veliparib (DRUG).
Who is sponsoring clinical trial NCT01638546?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01638546 being conducted?
This trial has 14 study locations across Florida, Georgia, Maryland, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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