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NCT01386385 · ClinicalTrials.gov registry record · Phase 1
Veliparib With or Without Radiation Therapy, Carboplatin, and Paclitaxel in Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
A Phase 1 study of Lung Adenocarcinoma and Stage IIIA Lung Non-Small Cell Cancer AJCC v7, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
- 20
- Study locations
NCT01386385 is a Phase 1 study of Lung Adenocarcinoma and Stage IIIA Lung Non-Small Cell Cancer AJCC v7 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 53 participants, below the 555-participant average among 14 other Lung Adenocarcinoma trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT01386385, a Phase 1 study of Lung Adenocarcinoma and Stage IIIA Lung Non-Small Cell Cancer AJCC v7, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I/II partially randomized trial studies the side effects and best dose of veliparib when given together with radiation therapy, carboplatin, and paclitaxel and to see how well it works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether radiation therapy, carboplatin, and paclitaxel are more effective with or without veliparib in treating non-small cell lung cancer.
Conditions Studied
Interventions
- DRUG Carboplatin
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- RADIATION 3-Dimensional Conformal Radiation Therapy
- OTHER Placebo Administration
Study Locations (20)
California
- Tower Cancer Research Foundation - Beverly Hills
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- City of Hope Corona - Corona
- City of Hope Comprehensive Cancer Center - Duarte
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Mercy Cancer Center - Merced
- University of California Davis Comprehensive Cancer Center - Sacramento
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Arizona
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Colorado
- UCHealth University of Colorado Hospital - Aurora
Connecticut
- Yale University - New Haven
Hawaii
- Hawaii Cancer Care Inc - Waterfront Plaza - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2011-06-20 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01386385
The ClinicalTrials.gov registry entry for NCT01386385 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 555-participant average among 14 other Lung Adenocarcinoma trials with a reported enrollment target (90% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Lung Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT01386385 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Alaska, Arizona.
Frequently Asked Questions
What is clinical trial NCT01386385 about?
NCT01386385 is a clinical study titled "Veliparib With or Without Radiation Therapy, Carboplatin, and Paclitaxel in Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery". This phase I/II partially randomized trial studies the side effects and best dose of veliparib when given together with radiation therapy, carboplatin, and paclitaxel and to see how well it works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Velipa...
What is the current status of trial NCT01386385?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2011-06-20. Estimated completion is 2026-12-31.
What conditions does trial NCT01386385 study?
This clinical trial studies the following conditions: Lung Adenocarcinoma, Stage IIIA Lung Non-Small Cell Cancer AJCC v7, Stage IIIB Lung Non-Small Cell Cancer AJCC v7, Stage III Lung Non-Small Cell Cancer AJCC v7, Lung Large Cell Carcinoma.
What interventions are being tested in trial NCT01386385?
The interventions under investigation include: Carboplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), 3-Dimensional Conformal Radiation Therapy (RADIATION), Placebo Administration (OTHER).
Who is sponsoring clinical trial NCT01386385?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01386385 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.