CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 110 enrolled
Drug / intervention
PF-05212384 (gedatolisib) +3 moredrug
Likely dose
PF-05212384 (gedatolisib) 90 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01920061
NCT01920061Phase 1Completed
CompareCT.gov

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

Pfizer·interventional·Posted Aug 9, 2013·Updated Sep 13, 2022

In Brief

A Phase 1 clinical trial evaluating PF-05212384 (gedatolisib), Docetaxel, and 2 other interventions for Neoplasm. Completed, enrolled 110 participants across 29 sites in 5 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasm
CountriesCanada, Italy, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 9, 2013
Enrollment StartSep 10, 2013
Primary CompletionJan 8, 2020
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 12.9 years ago

Interventions

PF-05212384 (gedatolisib)drug

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

Docetaxeldrug

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

Cisplatindrug

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

Dacomitinibdrug

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