Trial record 1 of 1 for:    NCT01506609
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The Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide or In Combination With Carboplatin and Paclitaxel Versus Placebo in Subjects With BRCA1 and BRCA2 Mutation and Metastatic Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01506609
First received: January 6, 2012
Last updated: April 4, 2014
Last verified: April 2014

January 6, 2012
April 4, 2014
January 2012
October 2014   (final data collection date for primary outcome measure)
Progression -Free Survival [ Time Frame: Radiographic evaluation every 9 weeks, clinical evaluation every cycle ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01506609 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: From Cycle 1 Day 1 until patient's death or 3 years post discontinuation ] [ Designated as safety issue: No ]
  • Clinical Benefit Rate (CBR) [ Time Frame: From Cycle 1 Day1 until patient's death or 3 years post discontinuation ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: From Cycle 1 Day 1 until patient's death or 3 years post discontinuation ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: From Randomization until patient's death or 3 years post discontinuation ] [ Designated as safety issue: No ]
  • Clinical Benefit Rate (CBR) [ Time Frame: From Randomization until patient's death or 3 years post discontinuation ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: From Randomization until patient's death or 3 years post discontinuation ] [ Designated as safety issue: No ]
Chemotherapy-Induced Peripheral Neuropathy (CIPN) [ Time Frame: From Cycle 1 Day 1 for subjects on the carboplatin and paclitaxel treatment arm, through 30 Day Follow-up Visit. ] [ Designated as safety issue: No ]
CIPN (as assessed by the EORTC QLQ-CIPN20 questionnaire and NCI-CTCAE 4.0 grading for peripheral neuropathy
Not Provided
 
The Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide or In Combination With Carboplatin and Paclitaxel Versus Placebo in Subjects With BRCA1 and BRCA2 Mutation and Metastatic Breast Cancer
A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

The Study Evaluating Efficacy And Tolerability of Veliparib in Combination with Temozolomide or Veliparib/Placebo in Combination with Carboplatin and Paclitaxel in Subjects with locally recurrent Breast Cancer not amenable to therapy with curative intent, or metastatic breast cancer and a documented (BRCA1) and (BRCA2) deleterious germline mutation.

Subjects will be randomized in a 1:1:1 ratio to one of the three 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. The Clinical Benefit Rate (CBR) and Objective Response Rate (ORR) as well as Progression-free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 will be assessed. Study visits will be conducted according to the protocol schedule and randomization group. 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: Veliparib
    Days 1 through 7 of 28-day cycle (in combination with Temozolomide) or Days 1 through 7 of 21-day cycle (in combination with Carboplatin and Paclitaxel).
    Other Name: ABT-888
  • Drug: Temozolomide
    Days 1 through 5 of 28-day cycle (in combination with veliparib).
    Other Name: Temodal
  • Drug: Carboplatin
    Day 3 of 21-day cycle
  • Drug: Paclitaxel
    Day 3 of 21-day cycle.
    Other Name: Taxol
  • Drug: Placebo
    Placebo comparator for Veliparib days 1 through 7 of 21-day cycle (in combination with carboplatin and/or paclitaxel).
  • Experimental: Veliparib with Temozolomide
    Veliparib on Day 1 thru 7 and temozolomide on Day 1 thru 5 of a 28-day cycle.
    Interventions:
    • Drug: Veliparib
    • Drug: Temozolomide
  • Experimental: Veliparib with Carboplatin and Paclitaxel
    Veliparib on Day 1 thru 7 and carboplatin/paclitaxel on Day 3 of a 21-day cycle.
    Interventions:
    • Drug: Veliparib
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Placebo Comparator: Placebo with Carboplatin and Paclitaxel
    Placebo on Day 1 thru 7 and carboplatin/paclitaxel on Day 3 of a 21-day cycle.
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
255
December 2015
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.
  • Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.
  • Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.
  • If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.
  • Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
  • Subject must have adequate bone marrow, renal and hepatic function.
  • Subject must not be pregnant or plan to conceive a child.

Exclusion Criteria:

  • Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1
  • More than 2 prior lines of cytotoxic chemotherapy
  • Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor.
  • Prior taxane therapy for metastatic breast cancer.
  • A history of or evidence of brain metastases or leptomeningeal disease.
  • A history of uncontrolled seizure disorder
  • Pre-existing neuropathy from any cause in excess of Grade 1
  • Known history of allergic reaction to cremophor/paclitaxel
  • Clinical significant uncontrolled conditions â€" active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.
  • Pregnant or breastfeeding
Both
18 Years and older
No
Contact: Raymond A. Knight, BS (847) 938-1378 raymond.knight@abbvie.com
Contact: Melissa Shah, BS (847) 938-3885 melissa.shah@abbvie.com
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Hungary,   Israel,   Netherlands,   Norway,   Poland,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Ukraine
 
NCT01506609
M12-895, 2011-002913-12
Yes
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Stacie P. Shepherd, MD AbbVie
AbbVie
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP