NCT01560104

Brief Summary

A Randomized, Double-Blind, Multicenter, Phase 2 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Metastatic or Advanced Non-Small-Cell Lung Cancer (NSCLC).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Feb 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 29, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 21, 2015

Status Verified

September 1, 2015

Enrollment Period

2.6 years

First QC Date

February 29, 2012

Last Update Submit

September 30, 2015

Conditions

Non-Small -Cell Lung Cancer

Keywords

RandomizedmetastaticABT-888paclitaxelnon-small cell lung cancerPARPveliparibprogression free survivalcarboplatin

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS)

    Radiographic evaluation starting from the third day of study treatment and on average every 6 weeks until documented progression or date of death from any cause, whichever came first, until patient is registered as off study.

Secondary Outcomes (3)

  • Overall Survival (OS)

    Monthly after patient is registered off study up to 36 months or until date of death from any cause, whichever came first.

  • Objective Response Rate (ORR)

    Radiographic evaluation starting from the third day of study treatment and on average every 6 weeks until documented progression or date of death from any cause, whichever came first, until patient is registered as off study.

  • Chemotherapy Induced Peripheral Neuropathy (CIPN)

    From date of screening, first day of study treatment and then every cycle (about every 3 weeks) until date of death from any cause or patient is registered as off study, whichever came first.

Study Arms (2)

veliparib and carboplatin and paclitaxel

EXPERIMENTAL

Veliparib on Days 1-7 and carboplatin and paclitaxel on Day 3 of a 21 day cycle

Drug: VeliparibDrug: CarboplatinDrug: paclitaxel

placebo and carboplatin and paclitaxel

PLACEBO COMPARATOR

Placebo on Days 1-7 and carboplatin and paclitaxel on Day 3 of a 21 day cycle

Drug: CarboplatinDrug: paclitaxelDrug: placebo

Interventions

VeliparibDRUG
Also known as: ABT-888
veliparib and carboplatin and paclitaxel
CarboplatinDRUG
placebo and carboplatin and paclitaxelveliparib and carboplatin and paclitaxel
paclitaxelDRUG
placebo and carboplatin and paclitaxelveliparib and carboplatin and paclitaxel
placeboDRUG
placebo and carboplatin and paclitaxel

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must have cytologically or histologically confirmed non-small cell lung cancer (NSCLC).
  • Subject must have metastatic or advanced non-small cell lung cancer (NSCLC) (stage IIIB or IV) that is not amenable to surgical resection or radiation with curative intent at time of study Screening.
  • Subject must have at least 1 unidimensional measurable non-small cell lung cancer (NSCLC) lesion on a Computed Tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1).
  • Subject must consent to provide available archived formalin fixed, paraffin embedded (FFPE) tissue sample of non-small cell lung cancer (NSCLC) lesion (primary or metastatic) for central review and biomarker analysis.
  • Subject must have no history of brain metastases or evidence of primary central nervous system (CNS) tumors as demonstrated by a baseline magnetic resonance imaging (MRI).
  • Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
  • Subjects with fluid retention, including ascites or pleural effusion, may be allowed at the discretion of the Investigator.

You may not qualify if:

  • Subject has a known hypersensitivity to platinum compounds.
  • Subjects with peripheral neuropathy ≥ grade 2.
  • Subjects with a known epidermal growth factor receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21. (Subjects with wild type epidermal growth factor receptor (EGFR), unknown status or other type of epidermal growth factor receptor (EGFR) mutation will be considered eligible).
  • Subject has received prior systemic anti-cancer therapy for metastatic non-small cell lung cancer (NSCLC).
  • Subject has received adjuvant chemotherapy ≤ 12 months prior to Cycle 1 Day 1.
  • Subject has received anti-cancer Chinese medicine or anti-cancer herbal remedies within 14 days prior to Cycle 1 Day 1.
  • Subject has undergone External Beam Radiation Therapy (EBRT) ≤ 8 weeks prior to Cycle 1 Day 1.
  • Clinically significant and uncontrolled major medical condition(s).
  • Subject has previously been treated with a poly-(ADP-ribose)-polymerase (PARP) inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ramalingam SS, Blais N, Mazieres J, Reck M, Jones CM, Juhasz E, Urban L, Orlov S, Barlesi F, Kio E, Keiholz U, Qin Q, Qian J, Nickner C, Dziubinski J, Xiong H, Ansell P, McKee M, Giranda V, Gorbunova V. Randomized, Placebo-Controlled, Phase II Study of Veliparib in Combination with Carboplatin and Paclitaxel for Advanced/Metastatic Non-Small Cell Lung Cancer. Clin Cancer Res. 2017 Apr 15;23(8):1937-1944. doi: 10.1158/1078-0432.CCR-15-3069. Epub 2016 Oct 10.

    PMID: 27803064DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungNeoplasm Metastasis

Interventions

veliparibCarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Vincent Giranda, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2012

First Posted

March 22, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 21, 2015

Record last verified: 2015-09