Trial intelligence / Profile preview

GDC-0980 vs Everolimus in Metastatic Renal Cell Carcinoma

NCT01442090Phase 2

Key facts

Status: Completed
Start: Oct 2011
Primary completion: May 2013
Countries: 5
Sponsor: Genentech
Modality: Small Molecules

Drugs: apitolisib
Conditions: renal cell carcinoma (RCC)

Overview

Phase 2, randomised, open-label trial of apitolisib in renal cell carcinoma (RCC) (2 arms), sponsored by Genentech. Primary endpoint: Progression-Free Survival up to 23 months. Started Oct 2011; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

GDC-0980
Participants receive GDC-0980 (40 mg) orally daily.
Everolimus
Participants receive everolimus (10 mg) orally daily.

Who it enrols

Patients with metastatic renal cell carcinoma with a clear-cell component who have progressed on or within 6 months of stopping VEGF-targeted therapy.

Endpoints

Primary

Progression-Free Survivalup to 23 months

Secondary

Maximum Plasma Concentration of GDC-0980Week 9
Maximum Plasma Concentration of EverolimusWeek 9
Minimum Plasma Concentration of GDC-0980Week 9
Minimum Plasma Concentration of EverolimusWeek 9
Number of Participants with Adverse Eventsup to 30 days after end of treatment
Objective Tumor Responseup to 23 months
Duration of Objective Tumor Responseup to 23 months
Overall Survivalup to 45 months

Beyond the preview

Go deeper on NCT01442090.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01442090.