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
4 other identifiers
interventional
11
1 country
43
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2016
Typical duration for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2016
CompletedFirst Posted
Study publicly available on registry
April 5, 2016
CompletedStudy Start
First participant enrolled
September 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2020
CompletedResults Posted
Study results publicly available
March 6, 2020
CompletedFebruary 15, 2022
November 1, 2021
1.9 years
March 30, 2016
July 23, 2019
January 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of Objective Response Defined by RECIST 1.1 Criteria
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
approximate study duration 1 year 9 months
Secondary Outcomes (4)
Percentage of Participants Alive and Progression-free at 6 Months
Up to 6 months from enrollment
Median Progression-Free Survival Using RECIST 1.1 Criteria
Up to 2 years from enrollment
Median Overall Survival
up to 2 years from enrollment
The Frequency and Severity of CTCAE v4 Graded Adverse Events
approximately 1 year 9 months
Other Outcomes (1)
Mutation Subtypes and Clinical Outcomes
Up to 5 years
Study Arms (1)
Treatment (copanlisib)
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Patients may have received prior therapy (including chemotherapy, biologic/targeted therapy and immunotherapy) for treatment of endometrial cancer; all therapy must be discontinued at least 4 weeks prior to registration; any investigational agent must be discontinued at least 30 days prior to registration
- Patients must have had at least one prior chemotherapeutic regimen for management of endometrial carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen
- Patients are allowed to receive, but not required to receive, up to a total of 3 lines of chemotherapy
- Appropriate stage for study entry based on the following diagnostic workup:
- History/physical examination within 28 days prior to registration
- +17 more criteria
You may not qualify if:
- 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
- Hepatitis B (HBV) or hepatitis C (HCV); all patients must be screened for HBV and HCV up to 28 days prior to study drug start using the routine hepatitis virus laboratorial panel; patients with active HBV or hepatitis C infection are not eligible for enrollment; patients with serologic markers of HBV immunization due to known vaccination (hepatitis B surface antigen \[HBsAg\] negative, anti-hepatitis B core \[HBc\] negative and anti-hepatitis B surface \[HBs\] positive) will be eligible
- Previous or concurrent history of malignancies within 5 years prior to study treatment except for curatively treated:
- Cervical carcinoma in situ
- Non-melanoma skin cancer
- Superficial bladder cancer (Ta \[non-invasive tumor\], Tis \[carcinoma in situ\] and T1 \[tumor invades lamina propria\])
- Patients with seizure disorder requiring medication
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (43)
Yale University
New Haven, Connecticut, 06520, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, 87106, United States
Memorial Medical Center - Las Cruces
Las Cruces, New Mexico, 88011, United States
State University of New York Downstate Medical Center
Brooklyn, New York, 11203, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, 54482, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study did not continue on to the second stage of accrual.
Results Point of Contact
- Title
- Linda Gedeon on behalf of Virginia Filiaci, PhD.
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandro D Santin
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2016
First Posted
April 5, 2016
Study Start
September 16, 2016
Primary Completion
August 18, 2018
Study Completion
February 14, 2020
Last Updated
February 15, 2022
Results First Posted
March 6, 2020
Record last verified: 2021-11