Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

Temozolomide With or Without Veliparib in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer

NCT01638546 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 97 participants
Start Date 2012-07-27
Est. Completion 2026-03-25
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01638546

The ClinicalTrials.gov registry entry for NCT01638546 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01638546 reports 14 study locations spanning 10 distinct geographic areas — top geographies include New York, Maryland, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01638546?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Temozolomide (DRUG), Placebo Administration (OTHER), Veliparib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01638546?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial