Trial Outcomes & Findings for Everolimus and Gefitinib in Treating Patients With Progressive Glioblastoma Multiforme or Progressive Metastatic Prostate Cancer (NCT NCT00085566)
NCT ID: NCT00085566
Last Updated: 2016-01-20
Results Overview
Response will be evaluated in this study using the new international criteria Response Evaluation Criteria in Solid Tumors (RECIST)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
61 participants
Primary outcome timeframe
2 years
Results posted on
2016-01-20
Participant Flow
Participant milestones
| Measure |
RAD 001 30 mg
30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
RAD 001 50 mg
50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
RAD 001 70 mg
70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
57
|
|
Overall Study
COMPLETED
|
3
|
3
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
14
|
Reasons for withdrawal
| Measure |
RAD 001 30 mg
30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
RAD 001 50 mg
50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
RAD 001 70 mg
70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
10
|
|
Overall Study
Patient Not treated
|
0
|
0
|
3
|
|
Overall Study
Clinical progression
|
0
|
0
|
1
|
Baseline Characteristics
Everolimus and Gefitinib in Treating Patients With Progressive Glioblastoma Multiforme or Progressive Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
RAD 001 30 mg
n=3 Participants
30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
RAD 001 50 mg
n=3 Participants
50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
RAD 001 70 mg
n=57 Participants
70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsResponse will be evaluated in this study using the new international criteria Response Evaluation Criteria in Solid Tumors (RECIST)
Outcome measures
| Measure |
RAD 001 30 mg
n=3 Participants
30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
RAD 001 50 mg
n=3 Participants
50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
RAD 001 70 mg
n=43 Participants
70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
|---|---|---|---|
|
Overall Objective Response
Partial Response (PR)
|
0 participants
|
0 participants
|
2 participants
|
|
Overall Objective Response
Stable Disease (SD)
|
0 participants
|
1 participants
|
15 participants
|
|
Overall Objective Response
Progression of Disease (POD)
|
3 participants
|
2 participants
|
26 participants
|
Adverse Events
RAD 001 30 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
RAD 001 50 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
RAD 001 70 mg
Serious events: 18 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RAD 001 30 mg
n=3 participants at risk
30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
RAD 001 50 mg
n=3 participants at risk
50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
RAD 001 70 mg
n=57 participants at risk
70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
|---|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/3
|
0.00%
0/3
|
5.3%
3/57 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis/embolism (vascular access-related)
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis/thrombus/embolism
|
0.00%
0/3
|
0.00%
0/3
|
3.5%
2/57 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
Nervous system disorders
Confusion
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
3.5%
2/57 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/57
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/57
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/57
|
|
Blood and lymphatic system disorders
ALT, SGPT
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
Cardiac disorders
Cardiac General, other
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
General disorders
Death not associated w CTCAE term-Disease progression NOS
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
General disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
General disorders
Extremity-lower (gait/walking)
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemorrhage, Peritoneal cavity
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
Renal and urinary disorders
Incontinence, urinary
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
Infections and infestations
Infection, other
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
Nervous system disorders
Mood alteration - Agitation
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
General disorders
Muscle weakness - Extremity-lower
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
Nervous system disorders
Neurology - Other
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
General disorders
Pain - Head/headache
|
0.00%
0/3
|
0.00%
0/3
|
3.5%
2/57 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/upper respiratory - Other
|
0.00%
0/3
|
0.00%
0/3
|
1.8%
1/57 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3
|
0.00%
0/3
|
3.5%
2/57 • Number of events 2
|
Other adverse events
| Measure |
RAD 001 30 mg
n=3 participants at risk
30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
RAD 001 50 mg
n=3 participants at risk
50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
RAD 001 70 mg
n=57 participants at risk
70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
0.00%
0/3
|
0.00%
0/3
|
7.0%
4/57 • Number of events 4
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
14.0%
8/57 • Number of events 8
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
0.00%
0/3
|
0.00%
0/3
|
14.0%
8/57 • Number of events 8
|
|
Metabolism and nutrition disorders
AST, SGOT
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
10.5%
6/57 • Number of events 6
|
|
Metabolism and nutrition disorders
Calcium, low (hypocalcemia)
|
0.00%
0/3
|
0.00%
0/3
|
17.5%
10/57 • Number of events 10
|
|
Metabolism and nutrition disorders
Cholesterol, high (hypercholestremia)
|
0.00%
0/3
|
0.00%
0/3
|
5.3%
3/57 • Number of events 3
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/3
|
0.00%
0/3
|
7.0%
4/57 • Number of events 4
|
|
Reproductive system and breast disorders
Dyspnea (shortness of breath)
|
0.00%
0/3
|
0.00%
0/3
|
14.0%
8/57 • Number of events 8
|
|
General disorders
Edema: limb
|
0.00%
0/3
|
0.00%
0/3
|
8.8%
5/57 • Number of events 5
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
21.1%
12/57 • Number of events 12
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
33.3%
19/57 • Number of events 19
|
|
Blood and lymphatic system disorders
Hemoglobin
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
35.1%
20/57 • Number of events 20
|
|
Blood and lymphatic system disorders
Prothrombin Time and International Normalized Ratio
|
0.00%
0/3
|
0.00%
0/3
|
8.8%
5/57 • Number of events 5
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
17.5%
10/57 • Number of events 10
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
29.8%
17/57 • Number of events 17
|
|
General disorders
Mucositis (Clincal exam)- Oral cavity
|
0.00%
0/3
|
0.00%
0/3
|
7.0%
4/57 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/3
|
5.3%
3/57 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/3
|
0.00%
0/3
|
8.8%
5/57 • Number of events 5
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
0.00%
0/3
|
0.00%
0/3
|
10.5%
6/57 • Number of events 6
|
|
Blood and lymphatic system disorders
Platelets
|
0.00%
0/3
|
0.00%
0/3
|
7.0%
4/57 • Number of events 4
|
|
Blood and lymphatic system disorders
Partial Thromboplastin Time (PTT)
|
0.00%
0/3
|
0.00%
0/3
|
10.5%
6/57 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/3
|
0.00%
0/3
|
10.5%
6/57 • Number of events 6
|
|
Nervous system disorders
Seizure
|
0.00%
0/3
|
0.00%
0/3
|
10.5%
6/57 • Number of events 6
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
0.00%
0/3
|
0.00%
0/3
|
7.0%
4/57 • Number of events 4
|
|
Nervous system disorders
Neuropathy: sensory
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/57
|
|
General disorders
Pain - Bone
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/57
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/57
|
|
General disorders
Extremity-lower (gait/walking)
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/57
|
Additional Information
Dr. Howard Scher
Memorial Sloan Kettering Cancer Center
Phone: 646-422-4323
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place