Veliparib Monotherapy for Relapsed Ovarian Cancer With BRCA Mutation (Veli-BRCA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Vejle Hospital
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01472783
First received: November 2, 2011
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

The main purpose of this study is to investigate the effect of veliparib in ovarian cancer patients with known BRCA 1/2 mutations who do no longer respond to conventional chemotherapy.


Condition Intervention Phase
Recurrent, Epithelial Ovarian Cancer
Drug: Veliparib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Veliparib (ABT888) Monotherapy for Patients With BRCA Germline Mutation and Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Phase I: Maximum tolerated dose, dose limiting toxicity, recommended phase II dose. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Phase II: Response rate [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Veliparib Drug: Veliparib
Veliparib (tablet) 300 mg twice daily on days 1-28 of 28 days cycles until progression, unacceptable toxicity or patient refusal.

Detailed Description:

The side effects are modest, since PARP inhibitors affect cancer cells to a much larger extent than normal cells. The effect of this PARP-inhibiting treatment is evident although the greatest effect is seen in patients with mutations in BRCA genes. The reason for this is that BRCA deficient cancer cells are unable to repair both DNA double strand and single strand breaks and undergo apoptosis to a large extent.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. Stages I-IV.
  2. Patients with known germline BRCA1/2 mutations
  3. Verified progression by either RECIST criteria and/or GCIG CA125 criteria after previous first line chemotherapy or progression after later lines of cytotoxic treatment.
  4. Platinum resistance or partially platinum sensitive disease (Relapsed within six months of prior first line/later lines of platinum-based therapy or relapsed within six to twelve months of prior first line/later lines of platinum-based therapy)
  5. Age ≥ 18 years.
  6. Performance status 0-2.
  7. Measurable disease by RECIST 1.1 or evaluable by CA125 GCIG criteria
  8. Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to randomization):

    WBC ≥ 3.0 x 10^9/l or neutrophils (ANC) ≥ 1.5 x 10^9/l Platelet count ≥ 100 x 10^9/l Hemoglobin ≥ 9.7 g/dl (6 mmol/L) Serum bilirubin ≤ 1.5 x ULN Serum transaminases ≤ 2.5 x ULN Serum creatinine ≤ 1.5 x ULN

  9. Written informed consent.
  10. Tissue available for BRCAness analysis.

Exclusion Criteria:

  1. Previous treatment with a PARP inhibitor.
  2. Platinum-refractory disease (disease that progressed or was stable during prior platinum therapy)
  3. Patients who have received (or are planning to receive) treatment with any other investigational regimen, or who have participated in another clinical trial within 28 days prior to entering this trial.
  4. Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
  5. Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months after treatment
  6. Other present or previous malignancy except curatively treated cervical cancer stage I, non-melanotic skin cancer or other cancer with minimal risk of relapse.

    Curatively treated prior breast cancer is allowed if no relapse is suspected at time of inclusion.

  7. CNS metastasis.
  8. History of any chronic medical or psychiatric condition or laboratory abnormality that is not medically controlled or in the opinion of the Investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension, renal or liver disease).
  9. Allergy to the ingredients of the study medication.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472783

Contacts
Contact: Anders Jakobsen, DMSc anders.jakobsen@rsyd.dk
Contact: Karina D Steffensen, MD karina.dahl.steffensen@rsyd.dk

Locations
Denmark
Department of Oncology, Vejle Hospital Recruiting
Vejle, Denmark, 7100
Contact: Anders Jakobsen, DMSc       anders.jakobsen@rsyd.dk   
Contact: Karina D Steffensen, MD       karina.dahl.steffensen@rsyd.dk   
Principal Investigator: Karina D Steffensen, MD         
Sub-Investigator: Anders Jakobsen, MD         
Sponsors and Collaborators
Vejle Hospital
Abbott
Investigators
Study Chair: Anders Jakobsen, DMSc Vejle Hospital, Vejle, Denmark
  More Information

No publications provided

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT01472783     History of Changes
Other Study ID Numbers: Veli-BRCA
Study First Received: November 2, 2011
Last Updated: December 6, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Vejle Hospital:
BRCA1 mutation
BRCA2 mutation
Ovarian cancer
PARP inhibitor

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 23, 2014