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A Trial of ABT-888 in Combination With Temozolomide Versus Pegylated Liposomal Doxorubicin Alone in Ovarian Cancer

NCT01113957 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2018-06-06

No results posted yet for this study

Summary

The purpose of this study is to determine the objective response rate of ABT-888 when given in combination with temozolomide versus pegylated liposomal doxorubicin (PLD) alone in subjects with recurrent high grade serous ovarian cancer.

Conditions

Interventions

DRUG

ABT-888

Arm-A subjects will be given ABT-888 on Days 1 -7 every 28 days orally

DRUG

pegylated liposomal doxorubicin

Arm B subjects randomized to pegylated liposomal doxorubicin on Day 1, every 28 days intravenously.

DRUG

temozolomide

Arm A subjects will be given temozolomide on days 1-5 every 28 days orally with ABT-888

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Mark D McKee, MD · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States
  • Australia
  • Canada
  • Hungary
  • Israel
  • New Zealand
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01113957 on ClinicalTrials.gov