Trial Outcomes & Findings for Trial of the Combination of Bevacizumab and Everolimus in Patients With Refractory, Progressive Intracranial Meningioma (NCT NCT00972335)
NCT ID: NCT00972335
Last Updated: 2021-11-10
Results Overview
Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined per MacDonald criteria for response as ≥25% increase in size of enhancing tumor or any new tumor on MRI scan, neurologically worse, and steroids stable or increased.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
18 months
Results posted on
2021-11-10
Participant Flow
Participant milestones
| Measure |
Combination Therapy
Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.
Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of the Combination of Bevacizumab and Everolimus in Patients With Refractory, Progressive Intracranial Meningioma
Baseline characteristics by cohort
| Measure |
Combination Therapy
n=17 Participants
Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.
Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Includes all enrolled and treated patients (one patient not treated)
Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined per MacDonald criteria for response as ≥25% increase in size of enhancing tumor or any new tumor on MRI scan, neurologically worse, and steroids stable or increased.
Outcome measures
| Measure |
Combination Therapy
n=17 Participants
Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.
Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study
|
|---|---|
|
Progression-free Survival (PFS), in the Treatment of Patients With Refractory Meningioma.
|
22 months
Interval 4.5 to 26.8
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Includes all treated patients (one patient not treated)
Outcome measures
| Measure |
Combination Therapy
n=17 Participants
Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.
Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study
|
|---|---|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Diarrhea
|
6 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Thrombocytopenia
|
9 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Anemia
|
6 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Leukopenia
|
2 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Neutropenia
|
2 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Hypercholesterolemia
|
9 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Mucositis
|
9 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Fatigue
|
8 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Proteinuria
|
6 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Hypertriglyceridemia
|
6 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Rash/desquamation
|
6 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Hypertension
|
5 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Edema-limb
|
5 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Vomiting
|
4 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Anorexia
|
4 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Nausea
|
4 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Hyperglycemia
|
3 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Pain - oral cavity
|
3 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Epistaxis
|
3 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Headache
|
3 participants
|
|
To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.
Arthralgia
|
3 participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: The results were not analyzed at study closure as the data were not collected.
Outcome measures
Outcome data not reported
Adverse Events
Combination Therapy
Serious events: 10 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combination Therapy
n=17 participants at risk
Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.
Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study
|
|---|---|
|
Nervous system disorders
Ataxia
|
5.9%
1/17 • 18 months
|
|
Gastrointestinal disorders
Colitis
|
5.9%
1/17 • 18 months
|
|
General disorders
Death NOS
|
5.9%
1/17 • 18 months
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • 18 months
|
|
General disorders
Fatigue
|
5.9%
1/17 • 18 months
|
|
General disorders
General disorders and administration site conditions - Other, disease progression
|
5.9%
1/17 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.8%
2/17 • 18 months
|
|
Infections and infestations
Infections and infestations - Other, pneumonia
|
5.9%
1/17 • 18 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, change in mental status
|
11.8%
2/17 • 18 months
|
|
Nervous system disorders
Seizure
|
5.9%
1/17 • 18 months
|
|
Infections and infestations
urinary tract infection
|
5.9%
1/17 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • 18 months
|
Other adverse events
| Measure |
Combination Therapy
n=17 participants at risk
Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.
Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study
|
|---|---|
|
General disorders
Fatigue
|
70.6%
12/17 • 18 months
|
|
Nervous system disorders
Headache
|
64.7%
11/17 • 18 months
|
|
Gastrointestinal disorders
Mucositis
|
58.8%
10/17 • 18 months
|
|
Investigations
Platelet count decreased
|
58.8%
10/17 • 18 months
|
|
Investigations
Cholesterol high
|
52.9%
9/17 • 18 months
|
|
Blood and lymphatic system disorders
Anemia
|
47.1%
8/17 • 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
47.1%
8/17 • 18 months
|
|
Renal and urinary disorders
Proteinuria
|
47.1%
8/17 • 18 months
|
|
Vascular disorders
Hypertension
|
41.2%
7/17 • 18 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
41.2%
7/17 • 18 months
|
|
Gastrointestinal disorders
Nausea
|
41.2%
7/17 • 18 months
|
|
General disorders
Edema limbs
|
35.3%
6/17 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
35.3%
6/17 • 18 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
35.3%
6/17 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
35.3%
6/17 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
29.4%
5/17 • 18 months
|
|
Nervous system disorders
Dizziness
|
29.4%
5/17 • 18 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
29.4%
5/17 • 18 months
|
|
Nervous system disorders
Memory impairment
|
29.4%
5/17 • 18 months
|
|
Investigations
Alanine aminotransferase increased
|
23.5%
4/17 • 18 months
|
|
Metabolism and nutrition disorders
Anorexia
|
23.5%
4/17 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.5%
4/17 • 18 months
|
|
Psychiatric disorders
Insomnia
|
23.5%
4/17 • 18 months
|
|
Investigations
Neutrophil count decreased
|
23.5%
4/17 • 18 months
|
|
Infections and infestations
Infections and infestations - Other, pneumonia
|
17.6%
3/17 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
17.6%
3/17 • 18 months
|
|
Psychiatric disorders
Depression
|
17.6%
3/17 • 18 months
|
|
Gastrointestinal disorders
Dysphagia
|
17.6%
3/17 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.6%
3/17 • 18 months
|
|
Renal and urinary disorders
Hematuria
|
17.6%
3/17 • 18 months
|
|
Infections and infestations
Urinary tract infection
|
17.6%
3/17 • 18 months
|
|
Investigations
Weight loss
|
17.6%
3/17 • 18 months
|
|
Investigations
White blood cell decreased
|
17.6%
3/17 • 18 months
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
2/17 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
2/17 • 18 months
|
|
General disorders
Chills
|
11.8%
2/17 • 18 months
|
|
Gastrointestinal disorders
Constipation
|
11.8%
2/17 • 18 months
|
|
General disorders
Fever
|
11.8%
2/17 • 18 months
|
|
Injury, poisoning and procedural complications
Fracture
|
11.8%
2/17 • 18 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.8%
2/17 • 18 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.8%
2/17 • 18 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.8%
2/17 • 18 months
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
11.8%
2/17 • 18 months
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
11.8%
2/17 • 18 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
11.8%
2/17 • 18 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.8%
2/17 • 18 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, change in mental status
|
11.8%
2/17 • 18 months
|
|
Infections and infestations
Upper respiratory infection
|
11.8%
2/17 • 18 months
|
|
Nervous system disorders
Seizure
|
11.8%
2/17 • 18 months
|
|
Nervous system disorders
Tremor
|
11.8%
2/17 • 18 months
|
|
Renal and urinary disorders
Urinary frequency
|
11.8%
2/17 • 18 months
|
|
Renal and urinary disorders
Urinary retention
|
11.8%
2/17 • 18 months
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • 18 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
1/17 • 18 months
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.9%
1/17 • 18 months
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
1/17 • 18 months
|
|
Eye disorders
Blurred vision
|
5.9%
1/17 • 18 months
|
|
Investigations
Creatinine increased
|
5.9%
1/17 • 18 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • 18 months
|
|
Nervous system disorders
Dysgeusia
|
5.9%
1/17 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
1/17 • 18 months
|
|
General disorders
Edema
|
5.9%
1/17 • 18 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.9%
1/17 • 18 months
|
|
Eye disorders
Eye disorders - Other, vision changes
|
5.9%
1/17 • 18 months
|
|
General disorders
Flu like symptoms
|
5.9%
1/17 • 18 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, stomatitis
|
5.9%
1/17 • 18 months
|
|
General disorders
General disorders and administration site conditions - Other, disease progression
|
5.9%
1/17 • 18 months
|
|
Cardiac disorders
Heart Failure
|
5.9%
1/17 • 18 months
|
|
Vascular disorders
Hematoma
|
5.9%
1/17 • 18 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.9%
1/17 • 18 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.9%
1/17 • 18 months
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
5.9%
1/17 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
5.9%
1/17 • 18 months
|
|
Investigations
Lymphocyte count decreased
|
5.9%
1/17 • 18 months
|
|
Nervous system disorders
Nervous system disorders - Other, speech impairment
|
5.9%
1/17 • 18 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.9%
1/17 • 18 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.9%
1/17 • 18 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, renal failure
|
5.9%
1/17 • 18 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
5.9%
1/17 • 18 months
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
5.9%
1/17 • 18 months
|
|
Vascular disorders
Thromboembolic event
|
5.9%
1/17 • 18 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.9%
1/17 • 18 months
|
Additional Information
John D Hainsworth, MD
Sarah Cannon Research Institute
Phone: 1-877-691-7274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
- Publication restrictions are in place
Restriction type: OTHER