A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886)
Study identifier:D1532C00004
ClinicalTrials.gov identifier:NCT00600496
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment Complete
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
Medical condition
Breast Cancer
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD6244, Dacarbazine, Erlotinib, Docetaxel, Temsirolimus
Sex
All
Actual Enrollment
140
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 14 Dec 2007
Primary Completion Date: 20 Aug 2010
Estimated Study Completion Date: 31 Dec 2024
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Patricia LoRusso
Karmanos Cancer Institute
