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A Study Evaluating Efficacy of ABT-888 in Combination With Temozolomide in Metastatic Melanoma

NCT00804908 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2018-06-06

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of ABT-888 in combination with temozolomide versus temozolomide alone in subjects with metastatic melanoma.

Conditions

Interventions

DRUG

temozolomide

temozolomide capsule administered orally once daily for 5 days every 28 days

DRUG

ABT-888

ABT-888 capsule administered orally twice daily for 7 days every 28 days

OTHER

Placebo

Placebo for ABT-888 capsule administered orally twice daily for 7 days every 28 days

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • AbbVie Inc · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2016-01-31
Completion
2016-01-31

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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 NCT00804908 on ClinicalTrials.gov