Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Pfizer
Study ID
NCT01347866
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PF-05212384 — DRUG
    PF-05212384 intravenous infusion weekly starting at 110 mg.
  • PD-0325901 — DRUG
    PD-0325901 Oral twice daily (BID) dosing 2 mg BID 3 weeks on 1 week off
  • PF-05212384 — DRUG
    PF-05212384 intravenous infusion weekly starting at 95 mg.
  • irinotecan — DRUG
    Irinotecan by intravenous infusion at 180 mg/m2 every two weeks (Q x 2 week)

Study Details

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.

Key Dates

Start date
Oct 31, 2011
Status verified
Feb 2018
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
105 participants (actual)
Allocation
NON_RANDOMIZED
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Arm D: PF-05212384 + PD-0325901
  • Experimental: Arm C: PF-05212384 + irinotecan

Primary Outcome Measure

Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) [ Time Frame: Baseline up to 28 days ]

Locations (15)

FacilityCityStateZIPSite coordinators
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095-6984-
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095-
UCLA Medical CenterLos AngelesCalifornia90095-
UCLA Oncology CenterLos AngelesCalifornia90095-
Santa Monica - UCLA Medical Center and Orthopaedic HospitalSanta MonicaCalifornia90404-
UCLA Santa Monica Hematology OncologySanta MonicaCalifornia90404-
Anschutz Cancer PavilionAuroraColorado80045-
University of Colorado Denver (CTRC)AuroraColorado80045-
University of Colorado HospitalAuroraColorado80045-
University of Colorado Hospital Anschutz Inpatient PavilionAuroraColorado80045-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Medical University of South Carolina, Hollings Cancer CenterCharlestonSouth Carolina29425-
MUSC, Investigational Drug ServicesCharlestonSouth Carolina29425-
MUSC Health East CooperMt. PleasantSouth Carolina29464-
MUSC Specialty Care-NorthNorth CharlestonSouth Carolina29406-

Find similar trials in Los Angeles, CA

By research site
Ronald Reagan UCLA Medical Center· Los Angeles, CAUCLA Medical Center· Los Angeles, CAUCLA Oncology Center· Los Angeles, CASanta Monica - UCLA Medical Center and Orthopaedic Hospital· Santa Monica, CAUCLA Santa Monica Hematology Oncology· Santa Monica, CAAnschutz Cancer Pavilion· Aurora, CO

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