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A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886)

NCT00600496 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-11-13

No results posted yet for this study

Summary

This study is being conducted to determine if a combination of AZD6244 given orally twice a day with standard doses of selected chemotherapies will be safe and tolerable for cancer patients with advanced solid tumors. The highest tolerated dose of AZD6244 in combination with selected chemotherapies will be evaluated. The study will also investigate how AZD6244 in combination with standard chemotherapies are absorbed, distributed and excreted by the body as well as the length of time that the drugs remain in the body. Initial and periodic assessments will establish patient response to the combination therapies

Conditions

Interventions

DRUG

AZD6244

twice daily oral dose

DRUG

Dacarbazine

intravenous infusion

DRUG

Erlotinib

daily oral dose

DRUG

Docetaxel

intravenous infusion

DRUG

Temsirolimus

intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Patricia LoRusso, DO · Barbara Ann Karmanos Cancer Institute

  • Roger Cohen, MD · Fox Chase Cancer Center

  • Jeffrey Infante, MD · SCRI Development Innovations, LLC

  • Kevin Kim, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-14
Primary Completion
2010-08-20
Completion
2025-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00600496 on ClinicalTrials.gov