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)

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2011-003427-36-CZ
• Date of registration: 08/02/2012
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: 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)
• Scientific 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)
• Date of first enrolment: 23/03/2012
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003427-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Canada, Czech Republic, France, Germany, Hungary, Russian Federation, Slovakia, United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
Subject must be = 18 years of age.
Life expectancy > 12 weeks (as per Investigator's clinical assessment).
Subject must have cytologically or histologically confirmed NSCLC.
Subject must have metastatic or advanced 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 NSCLC lesion on a CT scan as defined by RECIST (version 1.1).
Subject must consent to provide available archived FFPE tissue sample of NSCLC lesion (primary or metastatic) for central review and biomarker analysis.
Subject must have no history of brain metastases or evidence of primary CNS tumors as demonstrated by a baseline 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.
Subject must have adequate bone marrow, renal and hepatic function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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 EGFR mutation of exon 19 deletion or L858R mutation in exon 21. (Subjects with wild type EGFR, unknown status or other type of EGFR mutation will be considered eligible).
Subject has received prior systemic anti-cancer therapy for metastatic NSCLC.
Subject has received adjuvant chemotherapy = 12 months prior to C1D1.
Subject has received anti-cancer Chinese medicine or anti-cancer herbal remedies within 14 days prior to C1D1.
Subject has undergone External Beam Radiation Therapy (EBRT) = 8 weeks prior to C1D1.
Clinically significant and uncontrolled major medical condition(s).
Subject has previously been treated with a PARP inhibitor.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Metastatic or Advanced Non-Small-Cell Lung Cancer (NSCLC)
MedDRA version: 14.1 Level: LLT Classification code 10025044 Term: Lung cancer System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: Veliparib 20 mg
Product Code: ABT-888
Pharmaceutical Form: Capsule
INN or Proposed INN: Veliparib
Current Sponsor code: ABT-888
Other descriptive name: VELIPARIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Name: Veliparib 40 mg
Product Code: ABT-888
Pharmaceutical Form: Capsule
INN or Proposed INN: Veliparib
Current Sponsor code: ABT-888
Other descriptive name: VELIPARIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Progression Free Survival

Main Objective: To assess if the addition of oral veliparib to carboplatin and paclitaxel compared to carboplatin and paclitaxel alone in subjects with metastatic or advanced NSCLC will improve progression-free survival (PFS).

Secondary Objective: To assess overall survival (OS), objective response rate, duration of response, chemotherapy-induced peripheral neuropathy (CIPN), safety, and tolerability.

Timepoint(s) of evaluation of this end point: Progression Free Survival is defined as the number of days from the date the subject was randomized to the date the subject experienced a confirmed event of disease progression (as determined by the central imaging center), or to the date of death (all causes of mortality), if disease progression is not reached.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Overall Survival - number of days from randomization to date of death
Objective Response Rate - subjects who have a partial or complete response based on assessment by central imaging read per RECIST 1.1.
Duration of Response - number of days from the day the criteria are met for complete response or partial response (whichever is recorded first) to the date that progressive disease is objectively documented by the central imaging center.
Chemotherapy-Induced Peripheral Neuropathy - scores from the EORTC QLQ-CIPN20 instrument will be evaluated and the area under the curve from baseline to Month 4 and 6 will be computed. In addition, the incidence of treatment-emergent grade 3 or 4 adverse events of peripheral neuropathy will be obtained.

Secondary end point(s): Overall Survival, Objective Response Rate, Duration of Response and Chemotherapy Induced Peripheral Neuropathy

Secondary ID(s)

2011-003427-36-DE

M10-898

Source(s) of Monetary Support

AbbVie Inc.