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Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT02728258•NRG Oncology

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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 to be recorded); each lesion must be \>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray; lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
•Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as 'non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
•Patients must have recovered from effects of recent surgery, radiotherapy, or chemotherapy; at least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy); there is no delay required for minor procedures (e.g., tumor fine-needle aspiration \[FNA\] or core biopsy, venous access device placement)
•Patients may have received prior radiation therapy for treatment of endometrial cancer; prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, intravaginal brachytherapy and/or palliative radiation therapy; all radiation therapy must be completed at least 4 weeks prior to registration
•Patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least 4 weeks prior to registration
+22 more criteria

Exclusion Criteria

•Patients who have had prior therapy with any phosphatidylinositol 3 kinase (PI3K)/v-akt murine thymoma viral oncogene homolog 1 (AKT)/mammalian target of rapamycin (mTor) pathway inhibitor
•Patients who have the following histologies: mucinous, squamous, sarcomas, carcinosarcomas, clear cell
•Congestive heart failure \> New York Heart Association (NYHA) class II
•Myocardial infarction or unstable angina less than 6 months before registration
•Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before registration
•Non-healing wound, ulcer or bone fracture
•Active, clinically serious infections \> Common Terminology Criteria for Adverse Events (CTCAE) grade 2
•History of, or current autoimmune disease
•Human immunodeficiency virus (HIV) infection
•Previous or concurrent history of malignancies within 5 years prior to study treatment except for curatively treated:
+16 more criteria

Locations (43)

Yale University

New Haven, Connecticut, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Northside Hospital

Atlanta, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Key Dates

Start Date

September 16, 2016

Primary Completion Date

August 18, 2018

Completion Date

February 14, 2020

Last Updated

February 15, 2022

Enrollment

ACTUAL participants

Conditions

Endometrial Endometrioid AdenocarcinomaEndometrial Mixed Cell AdenocarcinomaEndometrial Serous AdenocarcinomaEndometrial Undifferentiated CarcinomaMetastatic Endometrioid AdenocarcinomaRecurrent Uterine Corpus Cancer

Interventions

Copanlisib

DRUG

Laboratory Biomarker Analysis

OTHER

Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone

NCT03660826

Endometrial AdenocarcinomaEndometrial Mixed Cell Adenocarcinoma+4 more

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ACTIVE_NOT_RECRUITING

Prediction of Recurrence Among Low Risk Endometrial Cancer Patients

NCT04604613

FIGO Grade 1 Endometrial Endometrioid AdenocarcinomaFIGO Grade 2 Endometrial Endometrioid Adenocarcinoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone

Prediction of Recurrence Among Low Risk Endometrial Cancer Patients

Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma

Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial

Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer

Biomarkers in Blood and Tissue Samples From Patients With Uterine Cancer