Clinical Trial

Treatment of Breast Cancer

Study Description

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)

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).

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

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

Additional Information

Official Study 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

Clinical Trial ID

NCT01920061

ParticipAid ID

QbYy0b