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Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Patients With Advanced Cancer

NCT00101907 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2014-03-20

Study results available
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Summary

The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with gemcitabine and cisplatin chemotherapy. This is a Phase 1b clinical study.

Conditions

Interventions

DRUG

AMG 706

AMG 706 will be provided as 25-mg and 100-mg tablets and will be continuously self-administered orally once or twice daily based on cohort assignment starting on day 1 of Cycle 1.

BIOLOGICAL

Panitumumab

Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week cycle.

DRUG

Gemcitabine

Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m\^2.

DRUG

Cisplatin

Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m\^2.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2007-06-30
Completion
2008-04-30

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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 NCT00101907 on ClinicalTrials.gov