drugset
drugset / Trial / NCT00960960

A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole, in Participants With Locally Recurrent or Metastatic Breast Cancer

NCT00960960 ↗

Phase 1 Completed 71 enrolled Genentech, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) pictilisib administered with letrozole or intravenous (IV) paclitaxel with and without IV bevacizumab or IV trastuzumab in participants with locally recurrent or metastatic breast cancer. The study consists of three parts. Part 1 (pictilisib will be administered in 21+7 schedule along with paclitaxel and/or bevacizumab), Part 2 (pictilisib will be administered in 5+2 schedule along with paclitaxel and/or bevacizumab or trastuzumab) and Part 3 (pictilisib will be administered in combination with letrozole). Part 1 and Part 2 consists of two stages; a dose escalation stage and a cohort-expansion stage.

Timeline

Start
2009-08
Primary completion
2015-12
Completion
2015-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Pictilisib Small molecule 60 mg Oral
Subject Pictilisib Small molecule 100 mg Oral
Subject Pictilisib Small molecule 165 mg Oral
Subject Pictilisib Small molecule 180 mg Oral
Subject Pictilisib Small molecule 200 mg Oral
Subject Pictilisib Small molecule 250 mg Oral
Subject Pictilisib Small molecule 260 mg Oral
Subject Pictilisib Small molecule 330 mg Oral
Subject Trastuzumab Monoclonal antibody 2 mg/kg Intravenous
Subject Trastuzumab Monoclonal antibody 4 mg/kg Intravenous
Background Letrozole Other / unclassified 2.5 mg Oral
Background Paclitaxel Small molecule 90 mg/m2 Intravenous

Indications

breast cancer