Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer (NCT02728258) | Clinical Trial Compass
CompletedPhase 2
Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer
United States11 participantsStarted 2016-09-16
Plain-language summary
This phase II trial studies how well copanlisib works in treating patients with endometrial cancer that has not decreased or disappeared, and the cancer may still be in the body despite treatment (persistent) or has come back (recurrent). Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have the psychological ability and general health that permits completion of the study requirements and required follow-up
* Women of child-bearing potential (WOCBP) must agree to use adequate contraception when sexually active; patients should continue contraception for 6 months after finishing study drug
* Submission of tumor tissue is required for all patients; investigators should check with their site pathology department regarding release of biospecimens before approaching patients about participation in the trial
* Patients must have recurrent or persistent endometrial cancer (endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma or adenocarcinoma not otherwise specified \[NOS\]); histologic confirmation of the primary tumor is required
* All patients must have a somatic PIK3CA gene mutation (i.e., R88Q in exon 1, N345K in exon 4, C420R in exon 7, E542K, E545X \[E545A, E545D, E545G, and E545K\], Q546X \[Q546E, Q546K, Q546L, and Q546R\] in exon 9, and M1043I, H1047X \[H1047L, H1047R, and H1047Y\], or G1049R in exon 20) in a representative primary or metastatic tumor sample confirmed by the Roche COBAS PIK3CA Mutation Test at Q\^2 Solutions
* All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter …
What they're measuring
1
Frequency of Objective Response Defined by RECIST 1.1 Criteria
Timeframe: approximate study duration 1 year 9 months