NCT01653912

Dose-finding Study in Platinum-Resistant Ovarian Cancer

An Open-Label Phase I/II Study of GSK2110183 in Combination With Carboplatin and Paclitaxel in Subjects With Platinum-Resistant Ovarian Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Accenture · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* Dose-finding study of GSK2110183 administered in combination with carboplatin and paclitaxel to any subject with recurrent ovarian cancer. * Safety and efficacy study of GSK2110183 administered in combination with carboplatin and paclitaxel to subjects with platinum-resistant ovarian cancer.

Detailed description

PKB116611 is an open-label Phase I/II study of the investigational drug GSK2110183 given in combination with carboplatin and paclitaxel to subjects with recurrent ovarian cancer. Phase I is a dose escalation evaluation of daily oral doses of GSK2110183 administered in combination with every 3 week carboplatin and paclitaxel to any subject with recurrent ovarian cancer. Phase II is a single arm evaluation of the clinical efficacy of the combination identified in Phase I to subjects with platinum-resistant ovarian cancer.

Conditions

• Recurrent Platinum-resistant Ovarian Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-07-01
• Completion: 2015-11-01
• First posted: 2012-07-31
• Last updated: 2018-04-02
• Results posted: 2018-04-02

Locations

10 sites across 3 countries: Australia, Russia, United Kingdom