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Safety Profile, MTD, and PK Profile Studies of ABT-263 When Administered in Combination With Standard and Weekly Regimens of Docetaxel in Subjects With Cancer

NCT00888108 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2012-05-22

No results posted yet for this study

Summary

This is a Phase 1 open-label study evaluating the safety of ABT-263 when combined with a standard and weekly regimen of docetaxel in subjects who have solid tumors with measurable disease.

Conditions

Interventions

DRUG

ABT-263

150 mg of ABT-263 is taken orally once daily on Days 1-5 or Days 1-3 of each 21 day cycle. 150 mg of ABT-263 on Days 1-3, 8-10 and 15-17 of each 28-day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.

DRUG

Docetaxel

75 mg/m2 will be given by intravenous infusion on day 1 of each 21 -day cycle. 30 mg/m2 will be given by intravenous infusion on day 1, 8, 15 of each 28 -day cycle.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Abbott

    lead INDUSTRY

Principal Investigators

  • Mack Mabry, MD · Abbott

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States
  • Netherlands
  • United Kingdom

Study Locations

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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 NCT00888108 on ClinicalTrials.gov