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

June 9, 2015 updated by: Vejle Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Vejle, Denmark, DK-7100
        • Department of Oncology, Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Veliparib and Topotecan
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase I: Maximum tolerated dose, dose limiting toxicity and thus recommend phase II dose of veliparib
Time Frame: 1 month
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
Every three months, up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival of ovarian cancer patients treated with topotecan and veliparib
Time Frame: Every three months up to three years
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
Every three months, up to three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Collaborators

Abbott

Investigators

  • Study Chair: Anders Jakobsen, MD, DMSc, Vejle Hospital
  • Principal Investigator: Hanne Kanstrup, MD, Vejle Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (Estimate)

September 24, 2012

Study Record Updates

Last Update Posted (Estimate)

June 10, 2015

Last Update Submitted That Met QC Criteria

June 9, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VeTo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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