NCT01690468

PTX-200 and Carboplatin in Ovarian Cancer

A Phase IA/IB Trial of PTX-200 and Carboplatin in Patients With Platinum-Resistant Recurrent Ovarian Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Prescient Therapeutics, Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to determine if Triciribine (TCN) and carboplatin are safe and tolerable when given together, and to determine if this combination of drugs can help people with recurrent ovarian cancer.

Detailed description

The purpose of this study is to investigate the safety and tolerability, and determine the maximum tolerated dose of triciribine when combined with carboplatin in women with platinum-resistant, recurrent or persistent ovarian cancer. The secondary objectives are to evaluate the clinical activity of carboplatin plus triciribine in women with recurrent/persistent, platinum-resistant ovarian cancer by assessing response rate, progression-free survival, and duration of stable disease.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Triciribine	Triciribine (15, 25, 30, 35, or 45 mg/m\^2) on days 1, 8, 15 every 21 days. To be given as a 60 minute IV infusion.
DRUG	Carboplatin	Carboplatin will be administered on day 1 every 21 days, as a 30 minute IV infusion after completion of TCN.

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2012-09-21
• Last updated: 2020-09-24

Locations

1 site across 1 country: United States