Dasatinib in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, Endometrial or Peritoneal Cancer
Endometrial Clear Cell Adenocarcinoma
Estrogen Receptor Negative
Ovarian Clear Cell Cystadenocarcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Recurrent Uterine Corpus Carcinoma
Other: Laboratory Biomarker Analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of DCTD-Sponsored Dasatinib (NSC #732517 IND# 120636) in Recurrent/Persistent Ovary, Fallopian Tube, Primary Peritoneal, and Endometrial Clear Cell Carcinoma Characterized for the Retention or Loss of BAF250a Expression|
- Proportion of patients with objective tumor response rate (complete response [CR] or partial response [PR]) using RECIST version 1.1 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Duration of overall survival (OS) [ Time Frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years ] [ Designated as safety issue: No ]OS will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
- Duration of progression-free survival (PFS) [ Time Frame: Duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years ] [ Designated as safety issue: No ]PFS will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
- Incidence of adverse effects as assessed by Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]The frequency and severity of all toxicities are tabulated.
- ARID1A mutation status in formalin-fixed, paraffin embedded tissue using next-generation exon-capture sequencing [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]ARID1A mutation status will be tabulated to determine the correlation between BAF250a IHC and ARID1A mutations.
|Study Start Date:||February 2014|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (dasatinib)
Patients receive dasatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Names:Other: Laboratory Biomarker Analysis
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 BAF250a expression and in patients with loss of BAF250a expression.
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02059265
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|Principal Investigator:||David Hyman||NRG Oncology|