Conditions: Gynecologic Tumors
Keywords: Gynecologic tumors
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 33
Healthy volunteers: no

Brief summary:
This is a Phase 1, dose-escalation study in female patients with recurrent or persistent gynecologic tumors.

Detailed description:
This is a Phase 1, dose-escalation study in female patients with recurrent or persistent gynecologic tumors. The study will include a Screening Phase, a Treatment Phase and a Followup Phase. In the Screening Phase the subject's eligibility for study participation will be determined; this phase can last up to 28 days. The Treatment Phase will begin when the subject starts study treatment and will continue until the subject is removed from study treatment. The Follow-up Phase will last for 30 days after the subject ends study treatment. The study will be conducted at approximately 1 site. Treatment cycle length is 28 days. Radiologic imaging will be repeated after every 2 cycles of treatment.

Arms:
arm 1: Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.

Interventions: intervention 1: Oral Topotecan intervention 2: Pazopanib
Intervention descriptions: intervention 1: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth. intervention 2: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth.

Protocol document: