A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886)
NCT ID: NCT00600496
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
140 participants
INTERVENTIONAL
2007-12-14
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
AZD6244 + docetaxel
AZD6244
twice daily oral dose
Docetaxel
intravenous infusion
2
AZD6244 + Dacarbazine
AZD6244
twice daily oral dose
Dacarbazine
intravenous infusion
3
AZD6244 + Erlotinib
AZD6244
twice daily oral dose
Erlotinib
daily oral dose
4
AZD6244 + Temsirolimus
AZD6244
twice daily oral dose
Temsirolimus
intravenous infusion
Interventions
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AZD6244
twice daily oral dose
Dacarbazine
intravenous infusion
Erlotinib
daily oral dose
Docetaxel
intravenous infusion
Temsirolimus
intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* WHO performance status 0-1
* Patients must be able to swallow AZD6244 capsules
Exclusion Criteria
* 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
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Patricia LoRusso, DO
Role: PRINCIPAL_INVESTIGATOR
Barbara Ann Karmanos Cancer Institute
Roger Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center
Jeffrey Infante, MD
Role: PRINCIPAL_INVESTIGATOR
SCRI Development Innovations, LLC
Kevin Kim, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Research Site
Detroit, Michigan, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
Houston, Texas, United States
Countries
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References
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Patel SP, Lazar AJ, Papadopoulos NE, Liu P, Infante JR, Glass MR, Vaughn CS, LoRusso PM, Cohen RB, Davies MA, Kim KB. Clinical responses to selumetinib (AZD6244; ARRY-142886)-based combination therapy stratified by gene mutations in patients with metastatic melanoma. Cancer. 2013 Feb 15;119(4):799-805. doi: 10.1002/cncr.27790. Epub 2012 Sep 12.
Infante JR, Cohen RB, Kim KB, Burris HA 3rd, Curt G, Emeribe U, Clemett D, Tomkinson HK, LoRusso PM. A phase I dose-escalation study of Selumetinib in combination with Erlotinib or Temsirolimus in patients with advanced solid tumors. Invest New Drugs. 2017 Oct;35(5):576-588. doi: 10.1007/s10637-017-0459-7. Epub 2017 Apr 19.
LoRusso PM, Infante JR, Kim KB, Burris HA 3rd, Curt G, Emeribe U, Clemett D, Tomkinson HK, Cohen RB. A phase I dose-escalation study of selumetinib in combination with docetaxel or dacarbazine in patients with advanced solid tumors. BMC Cancer. 2017 Mar 6;17(1):173. doi: 10.1186/s12885-017-3143-6.
Related Links
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D1532C00004 Clinical Report Synopsis
Other Identifiers
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D1532C00004
Identifier Type: -
Identifier Source: org_study_id