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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

NCT01506609

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: M12-895
  • SECONDARY ID: 2011-002913-12
  • NCT ID: NCT01506609

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
VeliparibABT-888Veliparib with Temozolomide
TemozolomideTemodalVeliparib with Temozolomide
CarboplatinVeliparib with Carboplatin and Paclitaxel
PaclitaxelTaxolVeliparib with Carboplatin and Paclitaxel
PlaceboPlacebo with Carboplatin and Paclitaxel

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Veliparib with TemozolomideExperimentalVeliparib on Day 1 thru 7 and temozolomide on Day 1 thru 5 of a 28-day cycle.
  • Veliparib
  • Temozolomide
Veliparib with Carboplatin and PaclitaxelExperimentalVeliparib on Day 1 thru 7 and carboplatin/paclitaxel on Day 3 of a 21-day cycle.
  • Veliparib
  • Carboplatin
  • Paclitaxel
Placebo with Carboplatin and PaclitaxelPlacebo ComparatorPlacebo on Day 1 thru 7 and carboplatin/paclitaxel on Day 3 of a 21-day cycle.
  • Carboplatin
  • Paclitaxel
  • Placebo

Eligibility 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
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression -Free Survival
Time Frame:Radiographic evaluation every 9 weeks, clinical evaluation every cycle
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival
Time Frame:From Cycle 1 Day 1 until patient's death or 3 years post discontinuation
Safety Issue:
Description:
Measure:Clinical Benefit Rate (CBR)
Time Frame:From Cycle 1 Day1 until patient's death or 3 years post discontinuation
Safety Issue:
Description:
Measure:Objective Response Rate
Time Frame:From Cycle 1 Day 1 until patient's death or 3 years post discontinuation
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:AbbVie (prior sponsor, Abbott)

Trial Keywords

  • temozolomide
  • Temodar
  • Paclitaxel
  • BRCA1 mutation carrier
  • Metastatic breast cancer
  • TMZ
  • Recurrent breast cancer
  • Carboplatin
  • ABT-888
  • veliparib
  • Breast cancer
  • Locally recurrent
  • Temodal
  • BRCA2 mutation carrier
  • PARP

Last Updated

October 6, 2017