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A Study of ABT-888 in Combination With Temozolomide for Colorectal Cancer

NCT01051596 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2019-04-02

Study results available
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Summary

People with colorectal cancer that cannot be cured by surgery are being asked to participate in this study.

The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with colorectal cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide, and will hopefully increase the killing of cancer cells, and decrease the tumors in the body.

ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in colorectal cancer.

This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888 has on colorectal cancer.

This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide for colorectal cancer.

Conditions

Interventions

DRUG

Temozolomide

150mg/m2 Days 1-5 of each 28 day cycle

DRUG

ABT-888

40mg orally BID Days 1-7 of each 28 day cycle

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Michael J Pishvaian, MD, PhD · Georgetown University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-06-30
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01051596 on ClinicalTrials.gov