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

NCT01690598 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2015-06-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Anders Jakobsen, MD, DMSc · Vejle Hospital

  • Hanne Kanstrup, MD · Vejle Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-01-31
Completion
2015-02-28

Countries

  • Denmark

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01690598 on ClinicalTrials.gov