Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 36
Summary
- Conditions
- Endometrial Adenosquamous Carcinoma
- Endometrial Clear Cell Adenocarcinoma
- Endometrial Mixed Cell Adenocarcinoma
- Endometrial Serous Adenocarcinoma
- Metastatic Endometrioid Adenocarcinoma
- Recurrent Uterine Corpus Carcinoma
- Stage IV Uterine Corpus Cancer AJCC v7
- Stage IVA Uterine Corpus Cancer AJCC v7
- Stage IVB Uterine Corpus Cancer AJCC v7
- Uterine Corpus Carcinosarcoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
PRIMARY OBJECTIVES: I. Determine efficacy of single agent cabozantinib s-malate (cabozantinib) in women previously receiving one line of chemotherapy for metastatic endometrial cancer or with progression within 12 months of completing adjuvant therapy, with co-primary endpoints of objective response...
PRIMARY OBJECTIVES: I. Determine efficacy of single agent cabozantinib s-malate (cabozantinib) in women previously receiving one line of chemotherapy for metastatic endometrial cancer or with progression within 12 months of completing adjuvant therapy, with co-primary endpoints of objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and progression-free-survival at 12 weeks (PFS). SECONDARY OBJECTIVES: I. Correlation of clinical response with baseline molecular status of archival tumor (hepatocyte growth factor receptor [c-met] amplification & mutation status) and overall survival. OUTLINE: Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 4 weeks or every 6 months.
Tracking Information
- NCT #
- NCT01935934
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Neesha Dhani University Health Network-Princess Margaret Hospital