Trial Outcomes & Findings for RAD001 Plus Bevacizumab in Metastatic Melanoma (NCT NCT00591734)
NCT ID: NCT00591734
Last Updated: 2021-11-24
Results Overview
Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
13 months
Results posted on
2021-11-24
Participant Flow
Participant milestones
| Measure |
Intervention
All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
53
|
Reasons for withdrawal
| Measure |
Intervention
All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
35
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Intercurrent Illness
|
8
|
Baseline Characteristics
RAD001 Plus Bevacizumab in Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Intervention
n=57 Participants
All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
|
|---|---|
|
Age, Continuous
|
70 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 13 monthsLength of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
Outcome measures
| Measure |
Intervention
n=57 Participants
All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
|
|---|---|
|
Progression-free Survival
|
4 months
Interval 2.8 to 5.3
|
SECONDARY outcome
Timeframe: 1 yearOverall Survival is defined as the length of time, in months, that patients were alive from their first date of protocol treatment until death. For patients who were alive at the time of calculation, follow-up time was censored at date of last contact. The percentage of patients who were alive at 1 year is reported here. This was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Intervention
n=57 Participants
All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
|
|---|---|
|
Overall Survival Rate
|
43 percentage of participants
|
SECONDARY outcome
Timeframe: 13 monthsThe percentage of patients who experience an objective benefit from treatment (CR+PR). The response categories were assigned using RECIST criteria. Complete Response (CR) = Disappearance of all target lesions ; Partial Response (PR) = \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Intervention
n=57 Participants
All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
|
|---|---|
|
Objective Response Rate (ORR)
|
7 Participants
|
Adverse Events
Intervention
Serious events: 29 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=57 participants at risk
All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.8%
1/57 • Number of events 1
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
3.5%
2/57 • Number of events 2
|
|
Cardiac disorders
Hypertension
|
1.8%
1/57 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary arrest, non-fatal
|
1.8%
1/57 • Number of events 1
|
|
Blood and lymphatic system disorders
Coagulation - Other
|
1.8%
1/57 • Number of events 1
|
|
General disorders
Fever
|
3.5%
2/57 • Number of events 2
|
|
General disorders
Weakness
|
1.8%
1/57 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.8%
1/57 • Number of events 1
|
|
General disorders
Death
|
5.3%
3/57 • Number of events 3
|
|
General disorders
Pain - Abdomen
|
8.8%
5/57 • Number of events 5
|
|
Gastrointestinal disorders
Dehydration
|
3.5%
2/57 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
1/57 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/57 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis
|
1.8%
1/57 • Number of events 1
|
|
Gastrointestinal disorders
GI - Other
|
1.8%
1/57 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
1.8%
1/57 • Number of events 1
|
|
Infections and infestations
Infection - Pneumonia
|
5.3%
3/57 • Number of events 5
|
|
Immune system disorders
Angioedema
|
1.8%
1/57 • Number of events 1
|
|
Nervous system disorders
Confusion
|
1.8%
1/57 • Number of events 1
|
|
Nervous system disorders
Seizure
|
1.8%
1/57 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
1.8%
1/57 • Number of events 1
|
|
General disorders
Pain - Chest
|
3.5%
2/57 • Number of events 2
|
|
General disorders
Pain - GI
|
1.8%
1/57 • Number of events 1
|
|
General disorders
Pain - Head
|
1.8%
1/57 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.3%
3/57 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.8%
1/57 • Number of events 1
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
1.8%
1/57 • Number of events 1
|
|
Vascular disorders
Thrombus/Thrombosis/Embolism
|
1.8%
1/57 • Number of events 2
|
Other adverse events
| Measure |
Intervention
n=57 participants at risk
All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
|
|---|---|
|
Metabolism and nutrition disorders
Albumin
|
15.8%
9/57 • Number of events 20
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
12.3%
7/57 • Number of events 16
|
|
Immune system disorders
Allergic Reaction
|
7.0%
4/57 • Number of events 10
|
|
Metabolism and nutrition disorders
ALT
|
5.3%
3/57 • Number of events 3
|
|
Gastrointestinal disorders
Anorexia
|
47.4%
27/57 • Number of events 78
|
|
Metabolism and nutrition disorders
AST
|
10.5%
6/57 • Number of events 9
|
|
Metabolism and nutrition disorders
Cholesterol
|
31.6%
18/57 • Number of events 74
|
|
Psychiatric disorders
Confusion
|
5.3%
3/57 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
22.8%
13/57 • Number of events 34
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.8%
21/57 • Number of events 64
|
|
Metabolism and nutrition disorders
Creatinine
|
8.8%
5/57 • Number of events 9
|
|
Gastrointestinal disorders
Dehydration
|
10.5%
6/57 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Dermatology - Other
|
5.3%
3/57 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
43.9%
25/57 • Number of events 60
|
|
Gastrointestinal disorders
Dyspepsia
|
7.0%
4/57 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.4%
23/57 • Number of events 46
|
|
Blood and lymphatic system disorders
Edema: Head and Neck
|
8.8%
5/57 • Number of events 7
|
|
Blood and lymphatic system disorders
Edema - Limb
|
29.8%
17/57 • Number of events 51
|
|
General disorders
Fatigue
|
66.7%
38/57 • Number of events 144
|
|
General disorders
Fever
|
15.8%
9/57 • Number of events 10
|
|
Blood and lymphatic system disorders
Hemoglobin
|
49.1%
28/57 • Number of events 102
|
|
Blood and lymphatic system disorders
Hemorrhage - Nose
|
24.6%
14/57 • Number of events 23
|
|
Blood and lymphatic system disorders
Hemorrhage - Hematuria
|
7.0%
4/57 • Number of events 6
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.8%
5/57 • Number of events 13
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
24.6%
14/57 • Number of events 34
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.3%
3/57 • Number of events 3
|
|
Cardiac disorders
Hypertension
|
26.3%
15/57 • Number of events 72
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
26.3%
15/57 • Number of events 53
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.0%
4/57 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.5%
6/57 • Number of events 11
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.3%
7/57 • Number of events 18
|
|
Infections and infestations
Infection - Pneumonia
|
5.3%
3/57 • Number of events 4
|
|
Infections and infestations
Infection - Renal/Genitourinary
|
7.0%
4/57 • Number of events 6
|
|
Infections and infestations
Infection with Normal ANC
|
12.3%
7/57 • Number of events 16
|
|
Blood and lymphatic system disorders
INR
|
7.0%
4/57 • Number of events 10
|
|
General disorders
Insomnia
|
10.5%
6/57 • Number of events 21
|
|
Blood and lymphatic system disorders
Leukocytes
|
36.8%
21/57 • Number of events 44
|
|
Psychiatric disorders
Mood Alteration - Depression
|
7.0%
4/57 • Number of events 9
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
54.4%
31/57 • Number of events 81
|
|
Gastrointestinal disorders
Nausea
|
33.3%
19/57 • Number of events 42
|
|
Nervous system disorders
Neuropathy - Sensory
|
7.0%
4/57 • Number of events 13
|
|
Immune system disorders
Neutrophils
|
10.5%
6/57 • Number of events 8
|
|
General disorders
Pain - Abdomen
|
21.1%
12/57 • Number of events 23
|
|
General disorders
Pain - Back
|
12.3%
7/57 • Number of events 10
|
|
General disorders
Pain - Chest
|
14.0%
8/57 • Number of events 16
|
|
General disorders
Pain - Dental
|
10.5%
6/57 • Number of events 9
|
|
General disorders
Pain - GI
|
10.5%
6/57 • Number of events 11
|
|
General disorders
Pain - Head
|
26.3%
15/57 • Number of events 29
|
|
General disorders
Arthralgia
|
8.8%
5/57 • Number of events 14
|
|
General disorders
Pain - Limb
|
26.3%
15/57 • Number of events 50
|
|
General disorders
Myalgia
|
10.5%
6/57 • Number of events 9
|
|
Blood and lymphatic system disorders
Platelets
|
49.1%
28/57 • Number of events 75
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.5%
6/57 • Number of events 8
|
|
Metabolism and nutrition disorders
Proteinuria
|
38.6%
22/57 • Number of events 51
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
8.8%
5/57 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
45.6%
26/57 • Number of events 86
|
|
Gastrointestinal disorders
Taste Alteration
|
15.8%
9/57 • Number of events 35
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
5.3%
3/57 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
22.8%
13/57 • Number of events 18
|
|
General disorders
Weakness
|
5.3%
3/57 • Number of events 4
|
|
Metabolism and nutrition disorders
Weight Loss
|
17.5%
10/57 • Number of events 28
|
|
Skin and subcutaneous tissue disorders
Wound Complication
|
5.3%
3/57 • Number of events 9
|
Additional Information
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 days 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