NCT02728258

Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: NRG Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. TERTIARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• Endometrial Endometrioid Adenocarcinoma
• Endometrial Mixed Cell Adenocarcinoma
• Endometrial Serous Adenocarcinoma
• Endometrial Undifferentiated Carcinoma
• Metastatic Endometrioid Adenocarcinoma
• Recurrent Uterine Corpus Cancer

Interventions

Type	Name	Description
DRUG	Copanlisib	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2016-09-16
• Primary completion: 2018-08-18
• Completion: 2020-02-14
• First posted: 2016-04-05
• Last updated: 2022-02-15
• Results posted: 2020-03-06

Locations

43 sites across 1 country: United States