NCT02412371|TerminatedPhase 1/2ResultsDMCFDA Drug
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Phase 2 was not conducted due to a change in the standard of care for newly diagnosed, unresectable Stage III NSCLC
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)
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
48
1 country
12
Study Start
April 30, 2015
Actual (reported)Primary Completion
August 5, 2019
Actual (reported)Study Completion
August 5, 2019
Actual (reported)This study seeks to establish
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 5, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 6, 2014
Actual (reported)April 9, 2015
Actual (reported)April 30, 2015
Actual (reported)August 5, 2019
Actual (reported)August 5, 2019
Actual (reported)July 22, 2020
Actual (reported)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.
Objective Response Rate
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.
Participants in Phase 1 will be sequentially assigned to ascending dose levels of 60 mg, 80 mg, 120 mg, 200 mg, and 240 mg of twice daily (BID) veliparib in combination with carboplatin at an area under the concentration-time curve (AUC) 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks. After completion of concurrent chemoradiotherapy participants will receive up to 2 cycles of consolidation therapy consisting of veliparib 120 mg or 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants will receive veliparib at the recommended phase 2 dose determined in Phase 1 in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks. After completion of concurrent chemoradiotherapy participants will receive up to 2 cycles of consolidation therapy consisting of veliparib 120 mg or 240 mg BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Administered via intravenous infusion on Day 1 of each treatment week (concurrent CRT) / cycle (consolidation)
Ucsd /Id# 133037
La Jolla, California, 92093, United States
Christiana Care Health Service /ID# 133486
Newark, Delaware, 19713, United States
University of Chicago /ID# 133828
Chicago, Illinois, 60637-1443, United States
Univ Maryland School Medicine /ID# 132944
Baltimore, Maryland, 21201, United States
Dana-Farber Cancer Institute /ID# 133494
Boston, Massachusetts, 02215, United States
SUNY Upstate Medical University - Downtown /ID# 133492
Syracuse, New York, 13210, United States
Unc /Id# 133496
AbbVie Inc.
AbbVie
48 participants (actual enrollment reported by the registry).
First Submitted
November 6, 2014
Participants will receive veliparib at the recommended phase 2 dose determined in Phase 1 in combination with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks. After completion of concurrent chemoradiotherapy participants will receive up to 2 cycles of consolidation therapy consisting of placebo to veliparib BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Participants will receive placebo to veliparib with carboplatin at an AUC 2 mg/mL/min and paclitaxel 45 mg/m² once a week plus thoracic radiotherapy for 7 weeks. After completion of concurrent chemoradiotherapy participants will receive up to 2 cycles of consolidation therapy consisting of placebo to veliparib BID, carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m² administered on Day 1 of each 21-day cycle.
Capsule for oral administration
Administered via intravenous infusion on Day 1 of each treatment week (concurrent CRT) / cycle (consolidation)
Capsule for oral administration
Radiation treatment with total dose of 60 - 63 Gy administered on Days 1 to 5 of each week for 7 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center /ID# 133497
Durham, North Carolina, 27710-3000, United States
Wake Forest Univ HS /ID# 134608
Winston-Salem, North Carolina, 27157, United States
Rhode Island Hospital /ID# 133493
Providence, Rhode Island, 02903, United States
The Miriam Hospital /ID# 133910
Providence, Rhode Island, 02906, United States
University of Virginia /ID# 133495
Charlottesville, Virginia, 22908, United States
First Posted
April 9, 2015
Study Start
April 30, 2015
Actual (reported)Primary Completion
August 5, 2019
Actual (reported)Study Completion
August 5, 2019
Actual (reported)Last Updated
July 22, 2020
Results First Posted
July 22, 2020
Record last verified: 2020-07
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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