Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT02944396
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • pemetrexed — DRUG
    intravenous; administered on Day 1 via infusion in a 21-day cycle
  • nivolumab — DRUG
    intravenous; administered on Day 1 via infusion in a 21-day cycle
  • paclitaxel — DRUG
    intravenous; administered on Day 1 via infusion in a 21-day cycle
  • veliparib — DRUG
    oral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle
  • carboplatin — DRUG
    intravenous; administered on Day 1 via infusion in a 21-day cycle

Study Details

This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination with nivolumab and platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) (Phase 1 portion) and to assess whether the addition of nivolumab to veliparib in combination with platinum doublet chemotherapy results will improve progression free survival (PFS) compared to veliparib with platinum doublet chemotherapy alone in participants with metastatic or advanced Non-small Cell Lung Cancer (NSCLC) (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.

Key Dates

Start date
Dec 23, 2016
Status verified
Oct 2019
Primary completion
Oct 2, 2019
Completion
Oct 2, 2019

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Veliparib and nivolumab with platinum doublet chemotherapy
    Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)
  • Experimental: Veliparib with platinum doublet chemotherapy
    Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed)

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to approximately 3.5 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham - Main /ID# 155135BirminghamAlabama35233-
Icri /Id# 155593WhittierCalifornia90603-
Univ of Colorado Cancer Center /ID# 153820AuroraColorado80045-
University of Chicago /ID# 153824ChicagoIllinois60637-1443-
Goshen Center for Cancer Care /ID# 153822GoshenIndiana46526-
Duke University Medical Center /ID# 153821DurhamNorth Carolina27710-3000-

Find similar trials in Birmingham, AL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Alabama at Birmingham - Main· Birmingham, ALIcri· Whittier, CAUniv of Colorado Cancer Center· Aurora, COUniversity of Chicago· Chicago, ILGoshen Center for Cancer Care· Goshen, INDuke University Medical Center· Durham, NC

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