Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

May 31, 2015

Study Completion Date

November 30, 2017

Conditions
Ovarian Cancer
Interventions
DRUG

Pimasertib once daily

Pimasertib administered as oral capsule at a dose of 60 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.

DRUG

Pimasertib placebo

Placebo matching Pimasertib administered once daily in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.

DRUG

SAR245409 placebo

Placebo matching SAR245409 administered once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.

DRUG

SAR245409

SAR245409 administered as oral capsule at a dose of 70 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.

DRUG

Pimasertib twice daily

Pimasertib administered as oral capsule at a dose of 60 milligram (mg) twice daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.

Trial Locations (34)

2152

Research site, Northmead

3000

Research site, Leuven

4120

Research site, Greenslopes

6008

Research site, Subiaco

8500

Research site, Kortrijk

10065

Research site, New York

20910

Research site, Silver Spring

28033

Research site, Madrid

28046

Research site, Madrid

30912

Research site, Augusta

33076

Research site, Bordeaux

37203

Research site, Nashville

41013

Research site, Seville

43210

Research site, Columbus

45042

Research site, Middletown

45219

Research site, Cincinnati

46010

Research site, Valencia

46202

Research site, Indianapolis

48109

Research site, Ann Arbor

48202

Research site, Detroit

59901

Research site, Kalispell

60637

Research site, Chicago

63110

Research site, St Louis

64111

Research site, Kansas City

77030

Research site, Houston

02114

Research site, Boston

02215-5450

Research site, Boston

L8V 5C2

Research site, Hamilton

M4N 3M5

Research site, Toronto

H2L 4M1

Research site, Montreal

H2W 1S6

Research site, Montreal

G1R 2J6

Research site, Québec

41-500

Research site, Chorzów

07198

Research site, Palma Mallorca

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

EMD Serono

INDUSTRY

NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer | Biotech Hunter | Biotech Hunter