Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
62

Summary

Conditions
  • Endometrial Clear Cell Adenocarcinoma
  • Ovarian Clear Cell Cystadenocarcinoma
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Recurrent Uterine Corpus Cancer
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. To assess the clinical activity of dasatinib in patients with recurrent or persistent ovarian, fallopian tube, primary peritoneal, and endometrial clear cell carcinoma using objective tumor response (complete and partial): in patients without loss of BRG-associated factor 250a...

PRIMARY OBJECTIVES: I. To assess the clinical activity of dasatinib in patients with recurrent or persistent ovarian, fallopian tube, primary peritoneal, and endometrial clear cell carcinoma using objective tumor response (complete and partial): in patients without loss of BRG-associated factor 250a (BAF250a) expression and in patients with loss of BAF250a expression. SECONDARY OBJECTIVES: I. To examine the nature and degree of toxicity in this patient population treated with this regimen in patients with and without loss of BAF250a expression. II. To examine the progression-free survival and overall survival for this patient population receiving dasatinib in patients with and without loss of BAF250a expression. TERTIARY OBJECTIVES: I. To examine the agreement between BAF250a immunohistochemistry and AT rich interactive domain 1A (SWI-like) (ARID1A) mutation status using next generation sequencing performed in formalin-fixed, paraffin-embedded tumor tissue. OUTLINE: Patients receive dasatinib 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 3 months for 2 years and then every 6 months for 3 years.

Tracking Information

NCT #
NCT02059265
Collaborators
NRG Oncology
Investigators
Principal Investigator: David M Hyman NRG Oncology