Trial Outcomes & Findings for Everolimus and Bevacizumab in Advanced Non-Clear Cell Renal Cell Carcinoma (RCC) (NCT NCT01399918)
NCT ID: NCT01399918
Last Updated: 2022-02-01
Results Overview
the percent of patients alive and progression-free after 6 months of therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
6 months
Results posted on
2022-02-01
Participant Flow
Participant milestones
| Measure |
Everolimus and Bevacizumab
This is a single-institution, single-arm phase II trial of everolimus in combination with bevacizumab in patients with advanced non-clear cell RCC, who have not received prior VEGF-.or mTOR-targeted therapy.
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Everolimus and Bevacizumab
This is a single-institution, single-arm phase II trial of everolimus in combination with bevacizumab in patients with advanced non-clear cell RCC, who have not received prior VEGF-.or mTOR-targeted therapy.
|
|---|---|
|
Overall Study
Not eligible and not enrolled in the study
|
2
|
Baseline Characteristics
Everolimus and Bevacizumab in Advanced Non-Clear Cell Renal Cell Carcinoma (RCC)
Baseline characteristics by cohort
| Measure |
Everolimus and Bevacizumab
n=55 Participants
This is a single-institution, single-arm phase II trial of everolimus in combination with bevacizumab in patients with advanced non-clear cell RCC, who have not received prior VEGF-.or mTOR-targeted therapy.
|
|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 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
|
0 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsthe percent of patients alive and progression-free after 6 months of therapy.
Outcome measures
| Measure |
Everolimus and Bevacizumab
n=55 Participants
This is a single-institution, single-arm phase II trial of everolimus in combination with bevacizumab in patients with advanced non-clear cell RCC, who have not received prior VEGF-.or mTOR-targeted therapy.
|
|---|---|
|
To Evaluate the Efficacy of Combining Everolimus and Bevacizumab in Patients With Advanced RCC of Non-clear Cell Histology
|
78 percent of participants
|
SECONDARY outcome
Timeframe: 1 yearper the international criteria defined by the Response Evaluation Criteria in Solid Tumors Committee
Outcome measures
| Measure |
Everolimus and Bevacizumab
n=55 Participants
This is a single-institution, single-arm phase II trial of everolimus in combination with bevacizumab in patients with advanced non-clear cell RCC, who have not received prior VEGF-.or mTOR-targeted therapy.
|
|---|---|
|
Secondary Endpoint Will be the Overall Response Rate (ORR)
|
35 percent of participants with ORR
|
SECONDARY outcome
Timeframe: 2 yearsToxicity will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (Gompertz 1825),. Toxicities will be summarized by type and grade using frequencies and rates.
Outcome measures
| Measure |
Everolimus and Bevacizumab
n=55 Participants
This is a single-institution, single-arm phase II trial of everolimus in combination with bevacizumab in patients with advanced non-clear cell RCC, who have not received prior VEGF-.or mTOR-targeted therapy.
|
|---|---|
|
Participants Evaluated for Toxicity
|
55 Participants
|
Adverse Events
Everolimus and Bevacizumab
Serious events: 22 serious events
Other events: 55 other events
Deaths: 43 deaths
Serious adverse events
| Measure |
Everolimus and Bevacizumab
n=55 participants at risk
This is a single-institution, single-arm phase II trial of everolimus in combination with bevacizumab in patients with advanced non-clear cell RCC, who have not received prior VEGF-.or mTOR-targeted therapy.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
10.9%
6/55 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
2/55 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
1.8%
1/55 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.5%
3/55 • 2 years
|
|
Investigations
Blood bilirubin increased
|
1.8%
1/55 • 2 years
|
|
Hepatobiliary disorders
Cholecystitis
|
1.8%
1/55 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/55 • 2 years
|
|
Investigations
Creatinine increased
|
9.1%
5/55 • 2 years
|
|
General disorders
Death NOS
|
5.5%
3/55 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/55 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.5%
8/55 • 2 years
|
|
General disorders
Fatigue
|
3.6%
2/55 • 2 years
|
|
General disorders
Fever
|
3.6%
2/55 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
18.2%
10/55 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.5%
3/55 • 2 years
|
|
Vascular disorders
Hematoma
|
1.8%
1/55 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
1.8%
1/55 • 2 years
|
|
Infections and infestations
Lung infection
|
1.8%
1/55 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.8%
1/55 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
3.6%
2/55 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
1.8%
1/55 • 2 years
|
|
General disorders
Pain
|
1.8%
1/55 • 2 years
|
|
Cardiac disorders
Palpitations
|
1.8%
1/55 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
1/55 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
2/55 • 2 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.8%
1/55 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
1.8%
1/55 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
2/55 • 2 years
|
Other adverse events
| Measure |
Everolimus and Bevacizumab
n=55 participants at risk
This is a single-institution, single-arm phase II trial of everolimus in combination with bevacizumab in patients with advanced non-clear cell RCC, who have not received prior VEGF-.or mTOR-targeted therapy.
|
|---|---|
|
Vascular disorders
Hypertension
|
78.2%
43/55 • 2 years
|
|
General disorders
Fatigue
|
72.7%
40/55 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
70.9%
39/55 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
54.5%
30/55 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
41.8%
23/55 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
38.2%
21/55 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
38.2%
21/55 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
34.5%
19/55 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
15/55 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
27.3%
15/55 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.5%
14/55 • 2 years
|
|
General disorders
Edema limbs
|
21.8%
12/55 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
21.8%
12/55 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
11/55 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
20.0%
11/55 • 2 years
|
|
Nervous system disorders
Headache
|
18.2%
10/55 • 2 years
|
|
Investigations
Weight loss
|
18.2%
10/55 • 2 years
|
|
General disorders
Pain
|
16.4%
9/55 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
14.5%
8/55 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.5%
8/55 • 2 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
12.7%
7/55 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.9%
6/55 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
10.9%
6/55 • 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
10.9%
6/55 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
5/55 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
5/55 • 2 years
|
|
General disorders
Fever
|
9.1%
5/55 • 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
9.1%
5/55 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
5/55 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
7.3%
4/55 • 2 years
|
|
General disorders
Gen disorders & admin site conditions Other, spec
|
7.3%
4/55 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
7.3%
4/55 • 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
7.3%
4/55 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.3%
4/55 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
5.5%
3/55 • 2 years
|
|
Psychiatric disorders
Insomnia
|
5.5%
3/55 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.5%
3/55 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
5.5%
3/55 • 2 years
|
Additional Information
Dr. Darren Feldman
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place