CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 97 enrolled / 97 target
Drug / intervention
Temozolomide +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01638546
NCT01638546Phase 2ActiveUpdate Overdue (0.6/mo)Completion was 113mo ago

A Multi-Center, Randomized, Double-Blind Phase II Study Comparing ABT-888, a PARP Inhibitor, Versus Placebo With Temozolomide in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer

National Cancer Institute (NCI)·interventional·Posted Jul 11, 2012·Updated Jun 17, 2026

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Placebo Administration, and 2 other interventions for Recurrent Lung Small Cell Carcinoma. Active but no longer recruiting, targeting 97 participants across 14 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2Active
201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2012
Enrollment StartJul 27, 2012
Primary CompletionJan 9, 2017
Study CompletionMar 25, 2027
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 14.0 years ago

Arms & Interventions

Arm I (veliparib and temozolomide)experimental

Patients receive veliparib PO BID on days 1-7 and temozolomide PO on days 1-5.

Other: Laboratory Biomarker AnalysisDrug: TemozolomideDrug: Veliparib
Arm II (placebo and temozolomide)active_comparator

Patients receive placebo PO BID on days 1-7 and temozolomide as in Arm I.

Other: Laboratory Biomarker AnalysisOther: Placebo AdministrationDrug: Temozolomide

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Placebo Administrationother

Given PO

Temozolomidedrug

Given PO

Veliparibdrug

Given PO