Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Pilaralisib or Voxtalisib with Letrozole in HR+ HER2- Breast Cancer
NCT01082068Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2010
- Primary completion
- Apr 2013
- Countries
- 3
- Sponsor
- Sanofi
- Modality
- Small Molecules
- Conditions
- breast cancer
01
Overview
Phase 2, open-label trial of pilaralisib and voxtalisib in breast cancer (2 arms), sponsored by Sanofi. Primary endpoints: Safety and tolerability of XL147 and letrozole and XL765 and letrozole, Maximum Tolerated Dose and 1 more. Started Jun 2010; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
XL147 + Letrozole
Pilaralisib (XL147) orally once daily + Letrozole orally once daily
XL765 + Letrozole
Voxtalisib (XL765) orally twice daily + Letrozole orally once daily
03
Who it enrols
Postmenopausal women with ER+/PGR+ and HER2- breast cancer refractory to nonsteroidal aromatase inhibitors.
04
Endpoints
Primary
Safety and tolerability of XL147 and letrozole and XL765 and letrozole
Maximum Tolerated Dose
Progression-Free Survival at 3 months
Secondary
Other clinical benefit and efficacy parameters
Pharmacokinetics and pharmacodynamics
Beyond the preview
Go deeper on NCT01082068.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT01082068.