Overview

This trial is active, not recruiting.

Conditions breast cancer, breast neoplasms, colon cancer, colonic cancer, colon neoplasms, lung cancer, melanoma, kidney cancer
Treatments azd6244, dacarbazine, erlotinib, docetaxel, temsirolimus
Phase phase 1
Targets EGFR, MEK, mTOR
Sponsor AstraZeneca
Start date December 2007
End date August 2010
Trial size 211 participants
Trial identifier NCT00600496, D1532C00004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
AZD6244 + docetaxel
azd6244 ARRY-142886
twice daily oral dose
docetaxel Taxotere®
intravenous infusion
(Experimental)
AZD6244 + Dacarbazine
azd6244 ARRY-142886
twice daily oral dose
dacarbazine
intravenous infusion
(Experimental)
AZD6244 + Erlotinib
azd6244 ARRY-142886
twice daily oral dose
erlotinib
daily oral dose
(Experimental)
AZD6244 + Temsirolimus
azd6244 ARRY-142886
twice daily oral dose
temsirolimus
intravenous infusion

Primary Outcomes

Measure
Safety and tolerability of twice daily oral doses of AZD6244 when administered in combination with standard doses of selected chemotherapies.
time frame: 28 days +

Secondary Outcomes

Measure
PK of AZD6244 and selected chemotherapies.
time frame: Cycle 1 Day 3 and Cycle 2 day 1
Define highest tolerated dose of AZD6244 when in combination with selected chemotherapies.
time frame: 28 days +
Tumor response.
time frame: 28 days +

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

Inclusion Criteria: - Patients will have measurable and/or non-measurable disease, lacking curative options for whom the selected chemotherapy agents represent the standard of care - WHO performance status 0-1 - Patients must be able to swallow AZD6244 capsules Exclusion Criteria: - Prior treatment with a MEK inhibitor - Participation in a clinical study during the last 30 days or have not recovered from side effects of an investigational study drug - Brain metastases or spinal cord compression unless treated and stable (for at least 1 month) off steroids

Additional Information

Official title A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886) When Given in Combination With Standard Doses of Selected Chemotherapies to Patients With Advanced Solid Tumors
Principal investigator Patricia LoRusso, DO
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.