Non-small Cell Lung Cancer Stage III Clinical Trial
Official title:
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)
Verified date | July 2020 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 48 |
Est. completion date | August 5, 2019 |
Est. primary completion date | August 5, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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-adenosine diphosphate (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 radiotherapy 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. |
Country | Name | City | State |
---|---|---|---|
United States | Univ Maryland School Medicine /ID# 132944 | Baltimore | Maryland |
United States | Dana-Farber Cancer Institute /ID# 133494 | Boston | Massachusetts |
United States | Unc /Id# 133496 | Chapel Hill | North Carolina |
United States | University of Virginia /ID# 133495 | Charlottesville | Virginia |
United States | University of Chicago /ID# 133828 | Chicago | Illinois |
United States | Duke University Medical Center /ID# 133497 | Durham | North Carolina |
United States | Ucsd /Id# 133037 | La Jolla | California |
United States | Christiana Care Health Service /ID# 133486 | Newark | Delaware |
United States | Rhode Island Hospital /ID# 133493 | Providence | Rhode Island |
United States | The Miriam Hospital /ID# 133910 | Providence | Rhode Island |
United States | SUNY Upstate Medical University - Downtown /ID# 133492 | Syracuse | New York |
United States | Wake Forest Univ HS /ID# 134608 | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Dose-limiting Toxicities (DLTs) | 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 medical management, neutropenia for >7 days or neutropenic fever or thrombocytopenia =G2 seizure G4 diarrhea or nausea/vomiting despite antiemetic therapy for >48 hours Any other toxicity resulting in delay in RT, CT or veliparib >14 days or early DC of RT Other nonhematologic toxicities =G3, except anorexia, fatigue, G3 infection, G3 aspartate/alanine transferase (AST/ALT) elevations =7 days, infusion reactions, G3/4 lymphopenia or electrolyte abnormalities corrected to =G2 in <48 hours |
For Cohorts 1 - 5, from the start of veliparib dosing through 28 days after RT completion or until initiation of consolidation CT, approx. 10 weeks; For Cohort 6, 21 days from start of consolidation CT or until the start of cycle 2 consolidation therapy. | |
Secondary | Objective Response Rate | Objective response rate (ORR) is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) as assessed by the investigator using RECIST v1.1. Participants who did not meet complete response or partial response, including those who did not have post-baseline radiological assessments were considered as non-responders. Complete Response (CR): The disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis). Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Response must have been confirmed 4 weeks after the first documentation. |
Tumor assessments were performed prior to consolidation chemotherapy, 24 weeks after start of treatment, every 8 weeks until 1 year after start of treatment, and then every 12 weeks until disease progression; median time on follow-up was 11 months. |
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