Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02728258|
Recruitment Status : Active, not recruiting
First Posted : April 5, 2016
Results First Posted : March 6, 2020
Last Update Posted : September 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Endometrioid Adenocarcinoma Endometrial Mixed Cell Adenocarcinoma Endometrial Serous Adenocarcinoma Endometrial Undifferentiated Carcinoma Metastatic Endometrioid Adenocarcinoma 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)|
|Actual Enrollment :||11 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|
|Actual 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: approximate study duration 1 year 9 months ]Confirmed complete and partial tumor response by RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
- Percentage of Participants Alive and Progression-free at 6 Months [ Time Frame: Up to 6 months from enrollment ]Percentage of participants who are progression free at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Median Progression-Free Survival Using RECIST 1.1 Criteria [ Time Frame: September 16,2016 to April 4,2019, approximate duration of 2 years, 7 months ]The median progression-free survival time
- Median Overall Survival [ Time Frame: September 16,2016 to April 4,2019, approximate duration of 2 years, 7 months ]Median time of overall survival
- The Frequency and Severity of CTCAE v4 Graded Adverse Events [ Time Frame: Study Start: September 16, 2016, Primary Completion: June 30, 2018, approximate study duration 1 year 9 months ]Maximum grade of physician assessed adverse events reported during treatment
- 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
|Principal Investigator:||Alessandro D Santin||NRG Oncology|