Trial Outcomes & Findings for Monthly SOM230C for Recurrent or Progressive Meningioma (NCT NCT00859040)
NCT ID: NCT00859040
Last Updated: 2017-10-27
Results Overview
Progression is defined using Modified Macdonald Criteria , using a \>/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
6 months
Results posted on
2017-10-27
Participant Flow
Participant milestones
| Measure |
Participants With Atypical/Malignant Meningiomas
participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
Participants With Benign Meningiomas
participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Monthly SOM230C for Recurrent or Progressive Meningioma
Baseline characteristics by cohort
| Measure |
Participants With Atypical/Malignant Meningiomas
n=18 Participants
participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
Participants With Benign Meningiomas
n=16 Participants
participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
52 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Non-Hispanic
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American, Non-Hispanic
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino (Unknown Race)
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White (Unknown Ethnicity)
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
KPS scores
|
80 percent
n=5 Participants
|
90 percent
n=7 Participants
|
85 percent
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsProgression is defined using Modified Macdonald Criteria , using a \>/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Outcome measures
| Measure |
Participants With Atypical/Malignant Meningiomas
n=18 Participants
participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
Participants With Benign Meningiomas
n=16 Participants
participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
|---|---|---|
|
6 Month Progression Free Survival
|
11 percentage of patients
|
44 percentage of patients
|
SECONDARY outcome
Timeframe: 5 yearsNumber of participants to experience complete or partial response on study treatment. For response per Modified Macdonald Criteria, all measurable and evaluable lesions and sites must be assessed using the same techniques as baseline. 1. Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients must be on no steroids. 2. Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. The steroid dose at the time of the scan evaluation should be no greater than the maximum dose used in the first 8 weeks from initiation of therapy.
Outcome measures
| Measure |
Participants With Atypical/Malignant Meningiomas
n=18 Participants
participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
Participants With Benign Meningiomas
n=16 Participants
participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
|---|---|---|
|
Response Rate
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 5 yearsAll Grade 3-4-5 adverse events with a treatment attribution of probable, possible or definite based on CTCAE (v3.0) as reported on case report forms
Outcome measures
| Measure |
Participants With Atypical/Malignant Meningiomas
n=34 Participants
participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
Participants With Benign Meningiomas
participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
|---|---|---|
|
Treatment-related Events
Amylase
|
1 events
|
—
|
|
Treatment-related Events
Fatigue
|
2 events
|
—
|
|
Treatment-related Events
Hyperglycemia
|
8 events
|
—
|
|
Treatment-related Events
Hypoglycemia
|
1 events
|
—
|
|
Treatment-related Events
Hypokalemia
|
1 events
|
—
|
|
Treatment-related Events
Lipase
|
3 events
|
—
|
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
Participants With Atypical/Malignant Meningiomas
n=18 Participants
participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
Participants With Benign Meningiomas
n=16 Participants
participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
|---|---|---|
|
Median Progression-Free Survival
|
15 weeks
Interval 8.0 to 20.0
|
26 weeks
Interval 12.0 to 43.0
|
SECONDARY outcome
Timeframe: 34 monthsPopulation: Time to progression only reported for the 32 patients who have progressed (either on treatment or in follow-up). \[NOTE: The other 2 patients who were treated on study each remain progression-free after \> 1000 days.\]
Per protocol, the study's secondary objectives are to be evaluated "for the estimate of median ... PFS ... at time of interest." At this time, all study participants have been followed for progression for a minimum of 34 months (final patient to accrue to study was registered to trial on 06/14/2011), and study manuscript is currently being written-up with this information.
Outcome measures
| Measure |
Participants With Atypical/Malignant Meningiomas
n=32 Participants
participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
Participants With Benign Meningiomas
participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
|---|---|---|
|
Median Time to Progression
|
124 days
Interval 43.0 to 645.0
|
—
|
SECONDARY outcome
Timeframe: 34 monthsPercentage of participants alive 34 months after initiating study treatment. Median Overall Survival has not yet been reached for one study group; therefore, we are reporting Overall Survival rates by the end of the study time frame.
Outcome measures
| Measure |
Participants With Atypical/Malignant Meningiomas
n=18 Participants
participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
Participants With Benign Meningiomas
n=16 Participants
participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
|
|---|---|---|
|
Overall Survival
|
45 percentage of participants
|
73 percentage of participants
|
Adverse Events
SOM230C
Serious events: 7 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOM230C
n=34 participants at risk
Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)
SOM230C: Injection in the buttocks every 28 days
|
|---|---|
|
Nervous system disorders
somnolence
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
hypoglycemia
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperglycemia
|
2.9%
1/34 • Number of events 1
|
|
Vascular disorders
subdural hematoma
|
2.9%
1/34 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
secondary malignancy
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
extremity-lower (gait/walking)
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
sodium, serum-low (hyponatremia)
|
2.9%
1/34 • Number of events 1
|
Other adverse events
| Measure |
SOM230C
n=34 participants at risk
Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)
SOM230C: Injection in the buttocks every 28 days
|
|---|---|
|
Ear and labyrinth disorders
Hearing w/o audiogr not in monitor prg
|
5.9%
2/34
|
|
Ear and labyrinth disorders
Tinnitus
|
5.9%
2/34
|
|
Blood and lymphatic system disorders
Hemoglobin
|
20.6%
7/34
|
|
Blood and lymphatic system disorders
Leukocytes
|
8.8%
3/34
|
|
Blood and lymphatic system disorders
Neutrophils
|
8.8%
3/34
|
|
Blood and lymphatic system disorders
Platelets
|
11.8%
4/34
|
|
Cardiac disorders
QTc interval
|
5.9%
2/34
|
|
Cardiac disorders
Sinus bradycardia
|
5.9%
2/34
|
|
Cardiac disorders
Hypotension
|
8.8%
3/34
|
|
General disorders
Constitutional - Other
|
8.8%
3/34
|
|
General disorders
Fatigue
|
47.1%
16/34
|
|
General disorders
Insomnia
|
8.8%
3/34
|
|
Injury, poisoning and procedural complications
Bruising
|
8.8%
3/34
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
2/34
|
|
Skin and subcutaneous tissue disorders
Skin - Other
|
11.8%
4/34
|
|
Endocrine disorders
Thyroid function, high (hyperthyroidism, thyrotoxicosis)
|
8.8%
3/34
|
|
Metabolism and nutrition disorders
Anorexia
|
8.8%
3/34
|
|
Gastrointestinal disorders
Constipation
|
17.6%
6/34
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
2/34
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
44.1%
15/34
|
|
Gastrointestinal disorders
Dysphagia
|
8.8%
3/34
|
|
Gastrointestinal disorders
Flatulence
|
23.5%
8/34
|
|
Gastrointestinal disorders
GI - Other
|
14.7%
5/34
|
|
Gastrointestinal disorders
Nausea
|
23.5%
8/34
|
|
Nervous system disorders
Taste DIsturbance
|
5.9%
2/34
|
|
Gastrointestinal disorders
Vomiting
|
8.8%
3/34
|
|
Infections and infestations
Infection Gr0-2 neut- upper airway
|
5.9%
2/34
|
|
Infections and infestations
Infection Gr0-2 neut- urinary tract
|
5.9%
2/34
|
|
Infections and infestations
Infection - Other
|
5.9%
2/34
|
|
Investigations
Alkaline phosphatase
|
8.8%
3/34
|
|
Investigations
ALT - SGPT
|
8.8%
3/34
|
|
Investigations
Amylase
|
14.7%
5/34
|
|
Investigations
AST - SGOT
|
5.9%
2/34
|
|
Investigations
Creatinine
|
5.9%
2/34
|
|
Investigations
GGT
|
8.8%
3/34
|
|
Investigations
Cholesterol, serum-high (hypercholesteremia)
|
23.5%
8/34
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
47.1%
16/34
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
11.8%
4/34
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
8.8%
3/34
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
11.8%
4/34
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
11.8%
4/34
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
5.9%
2/34
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
11.8%
4/34
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
8.8%
3/34
|
|
Investigations
Lipase
|
11.8%
4/34
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory-other
|
11.8%
4/34
|
|
General disorders
Extremity-lower (gait/walking)
|
17.6%
6/34
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
8.8%
3/34
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
5.9%
2/34
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle weak
|
5.9%
2/34
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic right-side muscle weak
|
5.9%
2/34
|
|
Psychiatric disorders
Mood Alteration: Anxiety
|
8.8%
3/34
|
|
Nervous system disorders
Ataxia
|
20.6%
7/34
|
|
Nervous system disorders
Cognitive disturbance
|
8.8%
3/34
|
|
Psychiatric disorders
Confusion
|
8.8%
3/34
|
|
Psychiatric disorders
Mood Alteration: Depression
|
8.8%
3/34
|
|
Nervous system disorders
Dizziness
|
8.8%
3/34
|
|
Nervous system disorders
Memory Impairment
|
14.7%
5/34
|
|
Nervous system disorders
Neurologic - Other
|
14.7%
5/34
|
|
Nervous system disorders
Neuropathy CN V jaw / face-sensory
|
14.7%
5/34
|
|
Nervous system disorders
Neuropathy-motor
|
5.9%
2/34
|
|
Nervous system disorders
Neuropathy-sensory
|
17.6%
6/34
|
|
Nervous system disorders
Seizure
|
20.6%
7/34
|
|
Nervous system disorders
Speech Impairment
|
11.8%
4/34
|
|
Eye disorders
Ocular - Other
|
8.8%
3/34
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
11.8%
4/34
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
8.8%
3/34
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity/Limb
|
11.8%
4/34
|
|
General disorders
Pain - face
|
5.9%
2/34
|
|
Nervous system disorders
Pain - head/headache
|
61.8%
21/34
|
|
Gastrointestinal disorders
Pain - oral cavity
|
5.9%
2/34
|
|
General disorders
Pain - other
|
11.8%
4/34
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
2/34
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
5.9%
2/34
|
|
Renal and urinary disorders
Incontinence, urinary
|
8.8%
3/34
|
|
Renal and urinary disorders
Renal/GU - Other
|
8.8%
3/34
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
8.8%
3/34
|
Additional Information
Patrick Y. Wen, MD
Dana-Farber Cancer Institute / Brigham & Women's Hospital
Phone: 617-632-2166
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60