Spots Global Cancer Trial Database for Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer
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Trial Identification
Brief Title: Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer
Official Title: A Multi-arm Phase 1 Dose Escalation Study Of The Safety, Pharmacokinetics, And Pharmacodynamics Of The Dual Pi3k/Mtor Inhibitors Pf-04691502 And Pf-05212384 In Combination With Experimental Or Approved Anticancer Agents In Patients With Advanced Cancer
Study ID: NCT01347866
Conditions
Study Description
Brief Summary: After the fourth protocol amendment two study arms are evaluated in this clinical protocol: PD-0325901 (oral MEK inhibitor) plus PF-05212384 (intravenous PI3K/mTOR inhibitor) and PF-05212384 plus irinotecan. The study will assess safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer. Once the maximum tolerated doses are identified, further assessment of these combinations will be done in patients with previously treated metastatic colorectal or pancreatic cancer for the PF-05212384 plus irinotecan arm and in patients with ovarian cancer or KRAS mutated non small cell lung cancer for the combination of PF-05212384 plus PD-0325901.
Detailed Description: The study was prematurely discontinued as a result of an internal portfolio review on April 1, 2015. The decision to terminate was not due to any safety or efficacy data.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
UCLA Medical Center, Los Angeles, California, United States
UCLA Oncology Center, Los Angeles, California, United States
Santa Monica - UCLA Medical Center and Orthopaedic Hospital, Santa Monica, California, United States
UCLA Santa Monica Hematology Oncology, Santa Monica, California, United States
Anschutz Cancer Pavilion, Aurora, Colorado, United States
University of Colorado Denver (CTRC), Aurora, Colorado, United States
University of Colorado Hospital Anschutz Inpatient Pavilion, Aurora, Colorado, United States
University of Colorado Hospital, Aurora, Colorado, United States
Medical University of South Carolina, Hollings Cancer Center, Charleston, South Carolina, United States
Medical University of South Carolina, Charleston, South Carolina, United States
MUSC, Investigational Drug Services, Charleston, South Carolina, United States
MUSC Health East Cooper, Mount Pleasant, South Carolina, United States
MUSC Specialty Care-North, North Charleston, South Carolina, United States
Princess Margaret Hospital, Toronto, Ontario, Canada
Ospedale San Raffaele, Milano, , Italy
Hospital General Vall d'Hebron, Barcelona, , Spain
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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