Trial Outcomes & Findings for Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer (NCT NCT02728258)
NCT ID: NCT02728258
Last Updated: 2022-02-15
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
approximate study duration 1 year 9 months
Results posted on
2022-02-15
Participant Flow
The study was activated 9/16/2016 and the last patient was enrolled in May 2017. The study was officially closed to accrual on 8/7/2017 after the first stage of accrual was completed and all screened patients were either enrolled or refused. The study did not continue on to the second stage of accrual.
Tumor samples were screened for somatic "hotspot" PIK3CA gene mutations prior to enrollment.
Participant milestones
| Measure |
Copanlisib
IV copanlisib (60 mg weekly, day 1, 8 and 15 of 28-day cycle)
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Copanlisib
n=11 Participants
IV copanlisib (60 mg weekly, day 1, 8 and 15 of 28-day cycle)
|
|---|---|
|
Age, Customized
50-59 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: approximate study duration 1 year 9 monthsPopulation: Eligible and treated patients
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
Outcome measures
| Measure |
Copanlisib
n=11 Participants
IV copanlisib (60 mg weekly, day 1, 8 and 15 of 28-day cycle)
|
|---|---|
|
Frequency of Objective Response Defined by RECIST 1.1 Criteria
|
0.0 percentage of participants
Interval 0.0 to 28.5
|
SECONDARY outcome
Timeframe: Up to 6 months from enrollmentPopulation: Eligible and treated patients
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
Outcome measures
| Measure |
Copanlisib
n=11 Participants
IV copanlisib (60 mg weekly, day 1, 8 and 15 of 28-day cycle)
|
|---|---|
|
Percentage of Participants Alive and Progression-free at 6 Months
|
27 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 years from enrollmentPopulation: Eligible and treated patients
The median progression-free survival time
Outcome measures
| Measure |
Copanlisib
n=11 Participants
IV copanlisib (60 mg weekly, day 1, 8 and 15 of 28-day cycle)
|
|---|---|
|
Median Progression-Free Survival Using RECIST 1.1 Criteria
|
2.8 Months
Interval 1.6 to 8.9
|
SECONDARY outcome
Timeframe: up to 2 years from enrollmentPopulation: Eligible and treated patients
Median time of overall survival
Outcome measures
| Measure |
Copanlisib
n=11 Participants
IV copanlisib (60 mg weekly, day 1, 8 and 15 of 28-day cycle)
|
|---|---|
|
Median Overall Survival
|
15.2 Months
Interval 4.7 to 21.0
|
SECONDARY outcome
Timeframe: approximately 1 year 9 monthsPopulation: Eligible and treated patients
Maximum grade of physician assessed adverse events reported during treatment
Outcome measures
| Measure |
Copanlisib
n=11 Participants
IV copanlisib (60 mg weekly, day 1, 8 and 15 of 28-day cycle)
|
|---|---|
|
The Frequency and Severity of CTCAE v4 Graded Adverse Events
Grade 2
|
1 participants
|
|
The Frequency and Severity of CTCAE v4 Graded Adverse Events
Grade 3
|
7 participants
|
|
The Frequency and Severity of CTCAE v4 Graded Adverse Events
Grade 4
|
2 participants
|
|
The Frequency and Severity of CTCAE v4 Graded Adverse Events
Grade 1
|
1 participants
|
|
The Frequency and Severity of CTCAE v4 Graded Adverse Events
Grade 5
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsAssociations between mutation subtypes and clinical outcomes will be explored using standard statistical methods for categorical and time to event data.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Copanlisib)
Serious events: 4 serious events
Other events: 11 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Treatment (Copanlisib)
n=11 participants at risk
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.
Copanlisib: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.2%
2/11 • Number of events 2 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Infections and infestations
Cellulitis (other)
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
Other adverse events
| Measure |
Treatment (Copanlisib)
n=11 participants at risk
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.
Copanlisib: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
27.3%
3/11 • Number of events 3 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Gastrointestinal disorders
Abdominal Pain
|
36.4%
4/11 • Number of events 4 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Gastrointestinal disorders
Constipation
|
36.4%
4/11 • Number of events 4 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Gastrointestinal disorders
Rectal Pain
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Gastrointestinal disorders
Gastroparesis
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Gastrointestinal disorders
Mucositis Oral
|
27.3%
3/11 • Number of events 3 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • Number of events 4 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Gastrointestinal disorders
Oral Dysesthesia
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Gastrointestinal disorders
Toothache
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Gastrointestinal disorders
Vomiting
|
36.4%
4/11 • Number of events 4 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
General disorders
Chills
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
General disorders
Edema Limbs
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
General disorders
Fatigue
|
54.5%
6/11 • Number of events 6 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
General disorders
Fever
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
General disorders
Infusion Related Reaction
|
18.2%
2/11 • Number of events 2 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
General disorders
Localized Edema
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
General disorders
Non-Cardiac Chest Pain
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Infections and infestations
Sinusitis
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Infections and infestations
Skin Infection
|
18.2%
2/11 • Number of events 2 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Investigations
Cholesterol High
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Investigations
Creatinine Increased
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Investigations
Lymphocyte Count Decreased
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Investigations
Neutrophil Count Decreased
|
27.3%
3/11 • Number of events 3 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Investigations
White Blood Cell Decreased
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
27.3%
3/11 • Number of events 3 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
9.1%
1/11 • Number of events 1 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
27.3%
3/11 • Number of events 3 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Nervous system disorders
Syncope
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Renal and urinary disorders
Bladder Spasm
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Renal and urinary disorders
Urinary Incontinence
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Renal and urinary disorders
Urinary Urgency
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
2/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
1/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
36.4%
4/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
|
Vascular disorders
Hypertension
|
18.2%
2/11 • Assessed throughout the treatment period and up to 4 weeks after discontinuation of treatment
|
Additional Information
Linda Gedeon on behalf of Virginia Filiaci, PhD.
NRG Oncology
Phone: 716-845-1169
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60