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Veliparib (ABT888) Monotherapy for Patients With BRCA Germline Mutation and Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Recurrent, Epithelial Ovarian Cancer

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Trial Information

Veliparib (ABT888) Monotherapy for Patients With BRCA Germline Mutation and Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer

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.

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Maximum tolerated dose, dose limiting toxicity, recommended phase II dose.

Outcome Time Frame:

6 months

Safety Issue:



Denmark: Danish Medicines Agency

Study ID:




Start Date:

November 2011

Completion Date:

May 2014

Related Keywords:

  • Recurrent, Epithelial Ovarian Cancer
  • BRCA1 mutation
  • BRCA2 mutation
  • Ovarian cancer
  • PARP inhibitor
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial