Dasatinib in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, Endometrial or Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT02059265|
Recruitment Status : Active, not recruiting
First Posted : February 11, 2014
Results First Posted : May 17, 2019
Last Update Posted : September 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Clear Cell Adenocarcinoma Ovarian Clear Cell Cystadenocarcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Recurrent Uterine Corpus Carcinoma||Drug: Dasatinib Other: Laboratory Biomarker Analysis||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of DCTD-Sponsored Dasatinib in Recurrent/Persistent Ovary, Fallopian Tube, Primary Peritoneal, and Endometrial Clear Cell Carcinoma Characterized for the Retention or Loss of BAF250a Expression|
|Actual Study Start Date :||February 3, 2014|
|Actual Primary Completion Date :||November 11, 2016|
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: Laboratory Biomarker Analysis
- Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1 [ Time Frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression for up to 5 years. ]Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
- Duration of Overall Survival (OS) [ Time Frame: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years. ]Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
- 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 ]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 ]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 ]ARID1A mutation status will be tabulated to determine the correlation between BAF250a IHC and ARID1A mutations.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059265
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|Principal Investigator:||David M Hyman||NRG Oncology|