NCT01035658

Pazopanib/Doxil in Adv Relapsed Plat Sensitive or Resistant Ovarian, Fallopian or Primary Peritoneal Adenocarcinoma

A Phase I/II Study of the Combination of Pazopanib and Liposomal Doxorubicin (Doxil) in Patients With Advanced Relapsed Platinum-Sensitive or Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, patients with relapsed or refractory ovarian cancer will receive treatment with pazopanib and liposomal doxorubicin (Doxil) until disease progression or unacceptable toxicity occurs. The Phase I portion will define the dose limiting toxicity (DLT) of pazopanib and liposomal doxorubicin when administered in combination. Once the maximum tolerated dose has been identified in the Phase I portion, the Phase II portion will evaluate efficacy and safety of this combination in the same patient population.

Detailed description

In this study, patients with relapsed or refractory ovarian cancer will receive treatment with pazopanib and liposomal doxorubicin (Doxil) until disease progression or unacceptable toxicity occurs. The Phase I portion will define the dose limiting toxicity (DLT) of pazopanib and liposomal doxorubicin when administered in combination. Once the maximum tolerated dose has been identified in the Phase I portion, the Phase II portion will evaluate efficacy and safety of this combination in the same patient population.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Carcinoma

Interventions

Type	Name	Description
DRUG	Pazopanib	All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.
DRUG	Doxil	Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-06-01
• Completion: 2014-03-01
• First posted: 2009-12-21
• Last updated: 2021-10-28
• Results posted: 2015-05-21

Locations

4 sites across 1 country: United States