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Terminated Phase 1 Interventional Results available

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

ClinicalTrials.gov ID: NCT01347866

Public ClinicalTrials.gov record NCT01347866. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 4:09 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01347866
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1
Lead sponsor
Pfizer
Industry
Enrollment
105 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2011 (Actual)
Primary completion
Dec 2015 (Actual)
Completion
Dec 2015 (Actual)
Last update posted
Oct 29, 2018

2011 – 2015

United States locations

U.S. sites
15
U.S. states
3
U.S. cities
6
Facility City State ZIP Site status
Ronald Reagan UCLA Medical Center Los Angeles California 90095-6984 —
Ronald Reagan UCLA Medical Center Los Angeles California 90095 —
UCLA Medical Center Los Angeles California 90095 —
UCLA Oncology Center Los Angeles California 90095 —
Santa Monica - UCLA Medical Center and Orthopaedic Hospital Santa Monica California 90404 —
UCLA Santa Monica Hematology Oncology Santa Monica California 90404 —
Anschutz Cancer Pavilion Aurora Colorado 80045 —
University of Colorado Denver (CTRC) Aurora Colorado 80045 —
University of Colorado Hospital Anschutz Inpatient Pavilion Aurora Colorado 80045 —
University of Colorado Hospital Aurora Colorado 80045 —
Medical University of South Carolina, Hollings Cancer Center Charleston South Carolina 29425 —
Medical University of South Carolina Charleston South Carolina 29425 —
MUSC, Investigational Drug Services Charleston South Carolina 29425 —
MUSC Health East Cooper Mt. Pleasant South Carolina 29464 —
MUSC Specialty Care-North North Charleston South Carolina 29406 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01347866, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 29, 2018 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01347866 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →