Trial intelligence / Profile preview

Cediranib in Recurrent or Persistent Endometrial Carcinoma

NCT01132820Phase 2

Key facts

Status: Completed
Start: Jun 2010
Primary completion: Jan 2016
Countries: 1
Sponsor: National Cancer Institute
Modality: Small Molecules

Drugs: cediranib
Conditions: endometrial carcinoma

Overview

Phase 2, open-label, single-arm trial of cediranib in endometrial carcinoma, sponsored by National Cancer Institute. Primary endpoints: Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0 up to 5 years, Tumor Response and 1 more. Started Jun 2010; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Treatment (cediranib maleate)
Patients receive cediranib maleate PO daily.

Who it enrols

Patients with recurrent or persistent endometrial carcinoma who have received one prior chemotherapeutic regimen, have measurable disease, adequate organ function, and no prior VEGF-targeted therapy or clinically significant cardiovascular disease.

Endpoints

Primary

Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0Up to 5 years
Tumor ResponseAverage 3 months
Progression-free Survival (PFS) >= 6 MonthsUp to 5 years

Secondary

Overall SurvivalUp to 5 years
Progression Free SurvivalUp to 5 years
Response Without Regard to the Time of Documented ResponseUp to 6 months

Beyond the preview

Go deeper on NCT01132820.

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 NCT01132820.