Study identifier:D1532C00004
ClinicalTrials.gov identifier:NCT00600496
EudraCT identifier:N/A
CTIS identifier:N/A
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
Breast Cancer
Phase 1
No
AZD6244, Dacarbazine, Erlotinib, Docetaxel, Temsirolimus
All
140
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 May 2025 by AstraZeneca
AstraZeneca
-
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
Location
Location
Detroit, MI, United States, 48201
Location
Nashville, TN, United States, 37203
Location
Philadelphia, PA, United States, 19111
Location
Houston, TX, United States, 77030
Arms | Assigned Interventions |
---|---|
Experimental: 1 AZD6244 + docetaxel | Drug: AZD6244 twice daily oral dose Other Name: ARRY-142886 Drug: Docetaxel intravenous infusion Other Name: Taxotere® |
Experimental: 2 AZD6244 + Dacarbazine | Drug: AZD6244 twice daily oral dose Other Name: ARRY-142886 Drug: Dacarbazine intravenous infusion |
Experimental: 3 AZD6244 + Erlotinib | Drug: AZD6244 twice daily oral dose Other Name: ARRY-142886 Drug: Erlotinib daily oral dose |
Experimental: 4 AZD6244 + Temsirolimus | Drug: AZD6244 twice daily oral dose Other Name: ARRY-142886 Drug: Temsirolimus intravenous infusion |
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