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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Breast Cancer

Thank you

Trial Information

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


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.


Inclusion Criteria:



- 18 years of age, male and female.

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression -Free Survival

Outcome Time Frame:

Radiographic evaluation every 9 weeks, clinical evaluation every cycle

Safety Issue:

No

Principal Investigator

Stacie P. Shepherd, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M12-895

NCT ID:

NCT01506609

Start Date:

January 2012

Completion Date:

May 2015

Related Keywords:

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

Name

Location

Site Reference ID/Investigator# 62994Birmingham, Alabama  35294-3300
Site Reference ID/Investigator# 60754La Jolla, California  92093
Site Reference ID/Investigator# 60743Los Angeles, California  90025
Site Reference ID/Investigator# 60751Aurora, Colorado  80045
Site Reference ID/Investigator# 60749Boca Raton, Florida  33486
Site Reference ID/Investigator# 62995Fort Lauderdale, Florida  33308
Site Reference ID/Investigator# 60746Tampa, Florida  33612
Site Reference ID/Investigator# 60762West Palm Beach, Florida  33401
Site Reference ID/Investigator# 60757Chicago, Illinois  60637-1470
Site Reference ID/Investigator# 60744Zion, Illinois  60099
Site Reference ID/Investigator# 60748Baltimore, Maryland  21202
Site Reference ID/Investigator# 62724St. Louis, Missouri  63110
Site Reference ID/Investigator# 60756New York, New York  10003
Site Reference ID/Investigator# 60753Philadelphia, Pennsylvania  19104
Site Reference ID/Investigator# 60758Pittsburgh, Pennsylvania  15213
Site Reference ID/Investigator# 65487Memphis, Tennessee  38120
Site Reference ID/Investigator# 60742Houston, Texas  77030
Site Reference ID/Investigator# 62722Salt Lake City, Utah  84112
Site Reference ID/Investigator# 60750Little Rock, Arkansas  72205
Site Reference ID/Investigator# 60760Los Angeles, California  90048
Site Reference ID/Investigator# 65488Stanford, California  94305-5826
Site Reference ID/Investigator# 65489Chicago, Illinois  60612
Site Reference ID/Investigator# 60755Chicago, Illinois  60611
Site Reference ID/Investigator# 60759Baltimore, Maryland  21231
Site Reference ID/Investigator# 91213Baltimore, Maryland  21231
Site Reference ID/Investigator# 92633Baltimore, Maryland  21231
Site Reference ID/Investigator# 64582Boston, Massachusetts  02114
Site Reference ID/Investigator# 71193Lansing, Michigan  48912
Site Reference ID/Investigator# 62783New Brunswick, New Jersey  08901
Site Reference ID/Investigator# 63222New York, New York  10021
Site Reference ID/Investigator# 87973New York, New York  10003
Site Reference ID/Investigator# 87993New York, New York  10003
Site Reference ID/Investigator# 60747Durham, North Carolina  27710
Site Reference ID/Investigator# 62723Hershey, Pennsylvania  17033-0850
Site Reference ID/Investigator# 60752Charleston, South Carolina  29425
Site Reference ID/Investigator# 60745Dallas, Texas  75390-9063