Dose-finding Study in Platinum-Resistant Ovarian Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

July 31, 2015

Study Completion Date

November 30, 2015

Conditions
Recurrent Platinum-resistant Ovarian Cancer
Interventions
DRUG

GSK2110183 in combination with carboplatin and paclitaxel

Phase I is a dose escalation evaluation of increasing doses of GSK2110183 administered on a continuous daily schedule in combination with carboplatin AUC 5 and paclitaxel 175mg/m2 given every three weeks for a maximum 6 cycles. The dosing regimen identified in Phase I will then be evaluated in Phase II, a single arm study focused on clinical efficacy. Treatment with the three drug regimen will continue for a maximum of 6 x 21 day cycles followed by continuous GSK2110183 at the single agent MTD. Subjects may continue on study drug until progression, death or unacceptable toxicity.

Trial Locations (10)

3011

Western Hospital, Footscray

3052

Royal Women's Hospital, Parkville

4029

Royal Brisbane and Women's Hospital, Herston

6009

Sir Charles Gairdner Hospital, Nedlands

8006

Peter MacCallum Cancer Centre, East Melbourne

198255

City Clinical Oncology Dispensary, Saint Petersburg

249036

Medical Radiology Scientific Center of Ministry of Healthcare and Social Development of RF, Omskaya

HA6 2RN

Mount Vernon Cancer Center, Northwood, Middlesex

GU2 7XP

Royal Surrey County Hospital NHS Foundation Trust, Guildford

W 12 0HS

Imperial College Healthcare NHS Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Accenture

INDUSTRY