Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT02728258|
Recruitment Status : Suspended (Scheduled Interim Monitoring)
First Posted : April 5, 2016
Last Update Posted : February 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Endometrioid Adenocarcinoma Endometrial Mixed Adenocarcinoma Endometrial Serous Adenocarcinoma Endometrial Undifferentiated Carcinoma Metastatic Endometrioid Adenocarcinoma PIK3CA Gene Mutation Recurrent Uterine Corpus Carcinoma||Drug: Copanlisib Other: Laboratory Biomarker Analysis||Phase 2|
I. To assess the activity of copanlisib (BAY 80-6946) in patients with persistent or recurrent endometrial carcinoma harboring phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PI3KCA) hotspot mutations with the frequency of objective response.
I. To estimate 6 month progression-free survival (PFS) and median PFS. II. To estimate the distribution of the duration of overall survival (OS). III. To assess the safety profile of copanlisib in endometrial cancer patients.
I. To systematically evaluate by sequencing the site (i.e., exome) and characteristics of PIK3CA mutations in endometrial cancer patients and correlate such mutations to overall response (OR), PFS, and OS in patients treated with copanlisib.
Patients receive copanlisib intravenously (IV) over 1 hour on days 1, 8, and 15. 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)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Evaluation of Copanlisib (BAY 80-6946), a Selective Inhibitor of PI3KCA, in Patients With Persistent or Recurrent Endometrial Carcinoma Harboring PIK3CA Hotspot Mutations|
|Actual Study Start Date :||September 16, 2016|
|Estimated Primary Completion Date :||June 30, 2020|
Experimental: Treatment (copanlisib)
Patients receive copanlisib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Frequency of objective response defined by RECIST 1.1 criteria [ Time Frame: Up to 5 years ]Confirmation of complete and partial responses in tumor evaluations at least 4 weeks apart is required. Exact 95% confidence limits, accounting for the interim analysis, will be provided.
- Incidence of adverse events of copanlisib using CTCAE version 4.03 [ Time Frame: Up to 5 years ]Frequencies of maximum grade of adverse events by term or category will be reported. Grade 5 adverse events will be individually reported.
- Median PFS using RECIST 1.1 criteria [ Time Frame: Duration of time from study entry to time of progression or death, whichever occurs first, or date of last contact, assessed up to 5 years ]Will be estimated using Kaplan-Meier product limit estimates.
- OS [ Time Frame: Duration of time from study entry to time of death or the date of last contact, assessed up to 5 years ]Will be estimated using Kaplan-Meier product limit estimates.
- PFS defined using RECIST 1.1 criteria [ Time Frame: Duration of time from study entry to time of progression or death, whichever occurs first, or date of last contact, assessed at 6 months ]Will be estimated using Kaplan-Meier product limit estimates.
- Mutation subtypes and clinical outcomes [ Time Frame: Up to 5 years ]Associations between mutation subtypes and clinical outcomes will be explored using standard statistical methods for categorical and time to event data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728258
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|Principal Investigator:||Alessandro Santin||NRG Oncology|