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Veliparib and Topotecan for Relapsed Ovarian Cancer With Negative or Unknown BRCA Status

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 24, 2012
Last Update Posted: June 10, 2015
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.
Information provided by (Responsible Party):
Vejle Hospital
September 17, 2012
September 24, 2012
June 10, 2015
November 2012
January 2015   (Final data collection date for primary outcome measure)
  • Phase I: Maximum tolerated dose, dose limiting toxicity and thus recommend phase II dose of veliparib [ Time Frame: 1 month ]
  • Phase II: To investigate response rates (based on either CA125 GCIG or RECIST criteria) of combination topotecan and veliparib (ABT888) in relapsed ovarian cancer with negative or unknown BRCA status [ Time Frame: Every three months, up to 3 years ]
Same as current
Complete list of historical versions of study NCT01690598 on ClinicalTrials.gov Archive Site
  • Progression free survival of ovarian cancer patients treated with topotecan and veliparib [ Time Frame: Every three months up to three years ]
  • Overall survival of ovarian cancer patients treated with topotecan and veliparib [ Time Frame: Every three months, up to three years ]
Same as current
Not Provided
Not Provided
Veliparib and Topotecan for Relapsed Ovarian Cancer With Negative or Unknown BRCA Status
Veliparib (ABT888) and Topotecan (Hycamtin®) for Patients With Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer With Negative or Unknown BRCA Status
The purpose of this study is to investigate the effect of combined topotecan and veliparib (ABT888) treatment in relapsed ovarian cancer with tumor progression and negative or unknown BRCA mutation status.
Not Provided
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: Veliparib
    Veliparib (tablet) twice daily on days 1-3, 7-9, and 14-16 in a 28 days cycle. In phase I the starting dose is 30 mg x 2.
  • Drug: Topotecan
    2 mg/m² iv over 30 minutes on days 2, 8, and 15 in cycles of 28 days. Topotecan is dosed at a maximum body surface area of 2 m².
Experimental: Veliparib and Topotecan
  • Drug: Veliparib
  • Drug: Topotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
February 2015
January 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
  2. Verified progression by either RECIST criteria and/or GCIG CA125 criteria after previous first line chemotherapy or progression after later lines of cytotoxic treatment.
  3. 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-twelve months of prior first line/later lines of platinum-based therapy
  4. Age ≥ 18 years.
  5. Performance status 0-2.
  6. Measurable disease by RECIST 1.1 or CA125 GCIG criteria
  7. Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to enrollment):

    • WBC ≥ 3.0 x 10^9/l or neutrophils (ANC) ≥ 1.5 x 10^9/l
    • Platelet count ≥ 100 x 109/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
  8. Written informed consent.
  9. Tissue available for BRCAness analysis/BRCA mutation analysis.

Exclusion Criteria:

  1. Prior treatment with a PARP inhibitor.
  2. Patients with BRCA1/2 germline mutation.
  3. Platinum-refractory disease (disease that progressed or was stable during prior platinum therapy)
  4. Patients who have received (or are planning to receive) treatment with any other investigational agent, or who have participated in another clinical trial within 28 days prior to entering this trial.
  5. Pregnant or breast-feeding. For fertile women a negative pregnancy test at screening is mandatory.
  6. Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months after treatment
  7. Other present or previous malignancy except curatively treated cervical cancer stage I, non-melanotic skin cancer or other cancer with minimal risk of relapse. Previous breast cancer is allowed, if disease free follow-up at least five years prior to enrollment.
  8. CNS metastasis.
  9. History of any chronic medical or psychiatric condition or laboratory abnormality, which 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).
  10. Allergy to the ingredients of the study medication.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Vejle Hospital
Vejle Hospital
Study Chair: Anders Jakobsen, MD, DMSc Vejle Hospital
Principal Investigator: Hanne Kanstrup, MD Vejle Hospital
Vejle Hospital
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP