A Study Evaluating the Efficacy and Tolerability of Veliparib in Combination With Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Subjects With Stage III Non-Small Cell Lung Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 10/21/2018 |
Start Date: | April 30, 2015 |
End Date: | February 28, 2019 |
A Phase 1 Dose Escalation and Phase 2 Randomized, Placebo-Controlled Study of the Efficacy and Tolerability of Veliparib in Combination With Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Subjects 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 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
subjects with Stage III non-small cell lung cancer (Phase 2 portion).
with concurrent Paclitaxel/Carboplatin-based chemoradiotherapy 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
subjects with Stage III non-small cell lung cancer (Phase 2 portion).
Inclusion Criteria:
1. Participants with Histologically or cytologically confirmed Stage III non-small cell
lung cancer (NSCLC).
2. Participants in the randomized portion of the study must have measurable disease per
Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria.
3. Participants must have V20 (volume of lung to receive 20 Gy radiotherapy according to
simulation) < 35%.
4. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score
of 0 - 1.
5. Participant must have adequate hematologic, renal, hepatic, and lung function.
6. Participant must consent to provide archived tissue or cytology sample of NSCLC lesion
for analysis.
Exclusion Criteria:
1. Participants with prior chemotherapy or radiotherapy (RT) for current NSCLC.
Participants curatively treated for past early stage NSCLC greater than 3 years ago
may be included.
2. Participants with prior exposure to poly-ADP-ribose polymerase (PARP) inhibitors.
3. Participants with known hypersensitivity to carboplatin, paclitaxel, or formulations
containing polyethoxylated castor oil (Cremophor).
4. Participants with prior mediastinal or thoracic radiotherapy. Prior tangential RT to
prior breast cancer is acceptable.
5. Participants with major surgery in the 4 weeks prior to randomization (Video-assisted
thoracoscopic surgery (VATS) and/or mediastinoscopy is not considered major surgery).
6. Participants with a previous or concurrent malignancy except for treated basal cell or
squamous cell skin cancer, in situ cervical cancer, or other cancer for which the
patient received potentially curative treatment and has been disease-free for 3 years
or is considered cured by the investigator if has been disease-free for less than 3
years.
7. Participant is pregnant or lactating.
8. Participant with sensory peripheral neuropathy of ≥ Grade 2 at baseline, unable to
swallow medication, or participants with prior history of seizure within the prior 12
months.
We found this trial at
12
sites
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