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

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. Identifier: NCT01472783
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : November 16, 2016
Information provided by (Responsible Party):
Vejle Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Recurrent, Epithelial Ovarian Cancer Drug: Veliparib Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Phase I: Maximum tolerated dose, dose limiting toxicity, recommended phase II dose. [ Time Frame: 6 months ]
  2. Phase II: Response rate [ Time Frame: Every 3 months ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: Every 3 months ]
  2. Overall survival [ Time Frame: Every 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01472783

Department of Oncology, Vejle Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
Vejle Hospital
Study Chair: Anders Jakobsen, DMSc Vejle Hospital, Vejle, Denmark

Responsible Party: Vejle Hospital Identifier: NCT01472783     History of Changes
Other Study ID Numbers: Veli-BRCA
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016

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
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents