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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)

NCT01920061 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-09-13

Study results available
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Summary

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).

Conditions

Interventions

DRUG

PF-05212384 (gedatolisib)

PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle

DRUG

Docetaxel

Docetaxel intravenous infusions once every 3 weeks starting at 75 mg/m\^2

DRUG

Cisplatin

Cisplatin intravenous infusions once every 3 weeks starting at 75 mg/m\^2

DRUG

Dacomitinib

Dacomitinib to be taken orally as a continuous once daily regimen at a starting dose of 30 mg

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-10
Primary Completion
2020-01-08
Completion
2020-01-08

Countries

  • United States
  • Canada
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01920061 on ClinicalTrials.gov