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Safety Study of ABT-263 in Combination With Gemzar (Gemcitabine) in Subjects With Solid Tumors

NCT00887757 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2017-11-21

No results posted yet for this study

Summary

This is a Phase 1 open-label study evaluating the safety of navitoclax (ABT-263) when combined with a standard regimen of gemcitabine in approximately 50 subjects with solid tumors and measurable disease.

Conditions

Interventions

DRUG

ABT-263

150mg of ABT-263 is taken orally once daily on Days 1-3 and Days 8-10 out of each 21 day cycle. 325 mg of ABT-263 is taken orally once daily on days 1-3, 8-10, 15-17 out of each 28 day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.

DRUG

gemcitabine

Gemcitabine 1000 mg/m2 will be given by intravenous infusion on Day 1 and Day 8 of each 21 day cycle. Gemcitabine 1000 mg/m2 will be given by intravenous infusion on days 1, 8 and 15 of each 28 day cycle.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • AbbVie

    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
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-11-30
Completion
2011-11-30

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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 NCT00887757 on ClinicalTrials.gov