Veliparib Monotherapy for Relapsed Ovarian Cancer With BRCA Mutation (Veli-BRCA)
Verified December 2013 by Vejle Hospital
Information provided by (Responsible Party):
First received: November 2, 2011
Last updated: December 6, 2013
Last verified: December 2013
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.
Recurrent, Epithelial Ovarian Cancer
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Veliparib (ABT888) Monotherapy for Patients With BRCA Germline Mutation and Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2015 (Final data collection date for primary outcome measure)
Veliparib (tablet) 300 mg twice daily on days 1-28 of 28 days cycles until progression, unacceptable toxicity or patient refusal.
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. Stages I-IV.
- Patients with known germline BRCA1/2 mutations
- Verified progression by either RECIST criteria and/or GCIG CA125 criteria after previous first line chemotherapy or progression after later lines of cytotoxic treatment.
- 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)
- Age ≥ 18 years.
- Performance status 0-2.
- Measurable disease by RECIST 1.1 or evaluable by CA125 GCIG criteria
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
- Written informed consent.
- Tissue available for BRCAness analysis.
- Previous treatment with a PARP inhibitor.
- Platinum-refractory disease (disease that progressed or was stable during prior platinum therapy)
- 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.
- Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
- Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months after treatment
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.
- CNS metastasis.
- 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).
- Allergy to the ingredients of the study medication.
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
||Anders Jakobsen, DMSc
||Vejle Hospital, Vejle, Denmark
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 2011
||December 6, 2013
||Denmark: Danish Medicines Agency
Keywords provided by Vejle Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 23, 2014
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Neoplasms by Histologic Type