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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Small -Cell Lung Cancer

Thank you

Trial Information

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)


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.


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 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome 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.

Safety Issue:

No

Principal Investigator

Vincent Giranda, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M10-898

NCT ID:

NCT01560104

Start Date:

February 2012

Completion Date:

October 2013

Related Keywords:

  • Non-Small -Cell Lung Cancer
  • carboplatin
  • non-small cell lung cancer
  • paclitaxel
  • metastatic
  • Randomized
  • veliparib
  • ABT-888
  • progression free survival
  • PARP
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Site Reference ID/Investigator# 63712Atlanta, Georgia  30322
Site Reference ID/Investigator# 63979Boise, Idaho  83712
Site Reference ID/Investigator# 63978Peoria, Illinois  61615-7828
Site Reference ID/Investigator# 67403Zion, Illinois  60099
Site Reference ID/Investigator# 65691Goshen, Indiana  46526
Site Reference ID/Investigator# 67045New Albany, Indiana  47150
Site Reference ID/Investigator# 65507Hackensack, New Jersey  07601
Site Reference ID/Investigator# 63966Philadelphia, Pennsylvania  19111
Site Reference ID/Investigator# 67004Philadelphia, Pennsylvania  19106
Site Reference ID/Investigator# 63744Germantown, Tennessee  38138
Site Reference ID/Investigator# 68862Chandler, Arizona  85224
Site Reference ID/Investigator# 67008Detroit, Michigan  48201
Site Reference ID/Investigator# 65508Lansing, Michigan  48912