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A Clinical Study Conducted in Multiple Centers Comparing Veliparib in Combination With Carboplatin and Paclitaxel Versus a Placebo in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer

Primary Purpose

Non-Small -Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Veliparib

Carboplatin

paclitaxel

placebo

About this trial

This is an interventional treatment trial for Non-Small -Cell Lung Cancer focused on measuring Randomized, metastatic, ABT-888, paclitaxel, non-small cell lung cancer, PARP, veliparib, progression free survival, carboplatin

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Life expectancy > 12 weeks (as per Investigator's clinical assessment).

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.

Exclusion Criteria: -Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

veliparib and carboplatin and paclitaxel

placebo and carboplatin and paclitaxel

Arm Description

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

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

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

Secondary Outcome Measures

Overall Survival (OS)

Continuously from date of randomization until date of death from any cause or until patient is registered as off study, whichever came first.

Objective Response Rate (ORR)

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Full Information

NCT ID

NCT01560104

First Posted

February 29, 2012

Last Updated

September 30, 2015

Sponsor

AbbVie (prior sponsor, Abbott)

1. Study Identification

Unique Protocol Identification Number

NCT01560104

Brief Title

A Clinical Study Conducted in Multiple Centers Comparing Veliparib in Combination With Carboplatin and Paclitaxel Versus a Placebo in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

Subjects will be randomized in a 2:1 ratio to one of the two treatment groups. The safety of each treatment group will be assessed by evaluating study drug exposure, adverse events, serious adverse events, all deaths, changes in laboratory determinations and vital sign parameters. Progression -Free Survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) will be assessed as well as Overall Survival (OS) and the Objective Response Rate (ORR). Study visits will be conducted according to the protocol schedule. Study visits will include physical examination, laboratory blood sample collection, and assessment of vital signs, medical history and urinalysis. 12-lead Electrocardiogram (ECG) will be performed at protocol specified visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small -Cell Lung Cancer

Keywords

Randomized, metastatic, ABT-888, paclitaxel, non-small cell lung cancer, PARP, veliparib, progression free survival, carboplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

veliparib and carboplatin and paclitaxel

Arm Type

Experimental

Arm Description

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

Arm Title

placebo and carboplatin and paclitaxel

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Veliparib

Other Intervention Name(s)

ABT-888

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Type

Drug

Intervention Name(s)

paclitaxel

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Time Frame

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 Outcome Measure Information:

Title

Overall Survival (OS)

Description

Continuously from date of randomization until date of death from any cause or until patient is registered as off study, whichever came first.

Time Frame

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

Title

Objective Response Rate (ORR)

Time Frame

Title

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Life expectancy > 12 weeks (as per Investigator's clinical assessment). 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. Exclusion Criteria: -Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor). 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vincent Giranda, MD

Organizational Affiliation

AbbVie

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

27803064

Citation

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.

Results Reference

derived

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