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NCT02412371 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Efficacy and Tolerability of Veliparib in Combination With Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Adults With Stage III Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT02412371: Clinical Trial Phase 1 study, sponsored by AbbVie.
NCT02412371 is a Phase 1 study that was terminated before completion, run by AbbVie. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02412371, a Phase 1 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This study seeks to establish * the recommended Phase 2 dose (RPTD) of veliparib in combination with concurrent paclitaxel/carboplatin-based chemoradiotherapy (CRT) and consolidation with paclitaxel/carboplatin-based chemotherapy (Phase 1 portion), and * to assess whether the addition of oral veliparib versus placebo to paclitaxel/carboplatin-based chemoradiotherapy with paclitaxel/carboplatin consolidation will improve progression-free survival (PFS) in adults with Stage III non-small cell lung cancer (Phase 2 portion). A strategy decision was made not to proceed to Phase 2 portion of this study due to change in standard of care.
Primary Outcome
DLTs were defined as the following events considered treatment-related by the Investigator, graded per Common Terminology Criteria for Adverse Events (CTCAE) v4.0. * Radiation-induced myelopathy/myelitis or ≥ Grade (G) 3 cardiac toxicity * Radiation-related pneumonitis resulting in delay in RT, CT, or veliparib of \>3 weeks or early discontinuation (DC) of RT (total dose \<50 Gy) * ≥G4 esophagitis or esophagitis, dysphagia, and odynophagia requiring treatment interruption of \>7 days despite me
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- RADIATION Radiotherapy
- DRUG Veliparib
- DRUG Placebo for Veliparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2015-04-30 |
| Est. Completion | 2019-08-05 |
| Phase | Phase 1 |
Why NCT02412371 stopped before completion
NCT02412371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT02412371 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02412371 about?
NCT02412371 is a clinical study titled "A Study Evaluating the Efficacy and Tolerability of Veliparib in Combination With Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Adults With Stage III Non-Small Cell Lung Cancer (NSCLC)". This study seeks to establish * the recommended Phase 2 dose (RPTD) of veliparib in combination with concurrent paclitaxel/carboplatin-based chemoradiotherapy (CRT) and consolidation with paclitaxel/carboplatin-based chemotherapy (Phase 1 portion), and * to assess whether the addition of oral velip...
What is the current status of trial NCT02412371?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2015-04-30. Estimated completion is 2019-08-05.
What interventions are being tested in trial NCT02412371?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Radiotherapy (RADIATION), Veliparib (DRUG), Placebo for Veliparib (DRUG).
Who is sponsoring clinical trial NCT02412371?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02412371's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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