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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 ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01506609
First Posted: January 10, 2012
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  Purpose
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.

Condition Intervention Phase
Metastatic Breast Cancer Drug: Veliparib Drug: Temozolomide Drug: Carboplatin Drug: Paclitaxel Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • Progression -Free Survival [ Time Frame: Radiographic evaluation every 9 weeks, clinical evaluation every cycle ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: From Cycle 1 Day 1 until patient's death or 3 years post discontinuation ]
  • Clinical Benefit Rate (CBR) [ Time Frame: From Cycle 1 Day1 until patient's death or 3 years post discontinuation ]
  • Objective Response Rate [ Time Frame: From Cycle 1 Day 1 until patient's death or 3 years post discontinuation ]

Other Outcome Measures:
  • 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. ]
    CIPN (as assessed by the EORTC QLQ-CIPN20 questionnaire and NCI-CTCAE 4.0 grading for peripheral neuropathy


Estimated Enrollment: 290
Study Start Date: January 23, 2012
Estimated Study Completion Date: December 15, 2017
Estimated Primary Completion Date: December 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Veliparib with Temozolomide
Veliparib on Day 1 thru 7 and temozolomide on Day 1 thru 5 of a 28-day cycle.
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
Experimental: Veliparib with Carboplatin and Paclitaxel
Veliparib on Day 1 thru 7 and carboplatin/paclitaxel on Day 3 of a 21-day cycle.
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: Carboplatin
Day 3 of 21-day cycle
Drug: Paclitaxel
Day 3 of 21-day cycle.
Other Name: Taxol
Placebo Comparator: Placebo with Carboplatin and Paclitaxel
Placebo on Day 1 thru 7 and carboplatin/paclitaxel on Day 3 of a 21-day cycle.
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).

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506609


  Show 128 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: David Maag, PhD AbbVie
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01506609     History of Changes
Other Study ID Numbers: M12-895
2011-002913-12 ( EudraCT Number )
First Submitted: January 6, 2012
First Posted: January 10, 2012
Last Update Posted: October 9, 2017
Last Verified: October 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
ABT-888
veliparib
temozolomide
Temodar
Paclitaxel
BRCA1 mutation carrier
Metastatic breast cancer
TMZ
Recurrent breast cancer
Carboplatin
Breast cancer
Locally recurrent
Temodal
BRCA2 mutation carrier
PARP

Additional relevant MeSH terms:
Veliparib
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Temozolomide
Albumin-Bound Paclitaxel
Carboplatin
Dacarbazine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors