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Completed Phase 1 Interventional Results available

A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)

ClinicalTrials.gov ID: NCT01920061

Public ClinicalTrials.gov record NCT01920061. 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 28, 2026, 7:38 AM 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 PHASE 1B OPEN-LABEL THREE-ARM MULTI-CENTER STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF PF-05212384 (PI3K/MTOR INHIBITOR) IN COMBINATION WITH OTHER ANTI-TUMOR AGENTS

Brief summary

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

This study will evaluate PF-05212384 (gedatolisib) PI3K/mTOR inhibitor)) in combination with either docetaxel, cisplatin or dacomitinib in select advanced solid tumors. The study will assess the safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer in order to determine the maximum tolerated dose in each combination. The cisplatin combination expansion portion will evaluate the anti tumor activity of PF 05212384 plus cisplatin in patients with TNBC in 2 separate Arms (Arm 1 and Arm 2).

Study identification

NCT ID
NCT01920061
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Pfizer
Industry
Enrollment
110 participants

Conditions and interventions

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
Sep 10, 2013 (Actual)
Primary completion
Jan 8, 2020 (Actual)
Completion
Jan 8, 2020 (Actual)
Last update posted
Sep 13, 2022

2013 – 2020

United States locations

U.S. sites
21
U.S. states
7
U.S. cities
11
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 —
University of Alabama at Birmingham Birmingham Alabama 35249 —
Ronald Reagan UCLA Medical Center Los Angeles California 90095 —
UCLA Hematology Oncology Los Angeles California 90095 —
Westwood Bowyer Clinic Los Angeles California 90095 —
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California 94115 —
Santa Monica UCLA Medical Center & Orthopaedic Hospital Santa Monica California 90404 —
UCLA Hematology Oncology Santa Monica California 90404 —
University of Colorado Denver CTO (CTRC) Aurora Colorado 80045 —
University of Colorado Hospital Aurora Colorado 80045 —
Brigham and Women's Hospital Boston Massachusetts 02115 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Dana Farber Cancer Institute Boston Massachusetts 02215 —
Harper Professional Building Detroit Michigan 48201 —
Karmanos Cancer Institute Detroit Michigan 48201 —
Fox Chase Cancer Center Philadelphia Pennsylvania 19111 —
Medical University of South Carolina/ University Hospital Charleston South Carolina 29425 —
Medical University of South Carolina Charleston South Carolina 29425 —
MUSC SCTR Research 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 8 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01920061, 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 Sep 13, 2022 · Synced Oct 28, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01920061 live on ClinicalTrials.gov.

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