6 Month Progression Free Survival
| Group | Value (percentage of patients) |
|---|---|
| Participants With Atypical/Malignant Meningiomas | 11 |
| Participants With Benign Meningiomas | 44 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this research study is to evaluate the effectiveness and safety of SOM230C in treating recurrent meningiomas. SOM230C is a newly discovered drug that may stop meningioma cells from growing abnormally. This drug has been used in treatment of other tumors, and information from those other research studies suggests that SOM230C may help to stop the growth of meningiomas.
Experimental
SOM230C
Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)
Outcomes the sponsor listed as primary.
6 Month Progression Free Survival
Time frame · 6 months
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).
Response Rate
Time frame · 5 years
Number 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.
Treatment-related Events
Time frame · 5 years
All 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
Median Progression-Free Survival
Time frame · 5 years
Median Time to Progression
Time frame · 34 months
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.
Overall Survival
Time frame · 34 months
Percentage 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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of patients) |
|---|---|
| Participants With Atypical/Malignant Meningiomas | 11 |
| Participants With Benign Meningiomas | 44 |
| Group | Value (participants) |
|---|---|
| Participants With Atypical/Malignant Meningiomas | 0 |
| Participants With Benign Meningiomas | 0 |
| Group | Value (events) |
|---|---|
| SOM230C | 1 |
| Group | Value (weeks) |
|---|---|
| Participants With Atypical/Malignant Meningiomas | 15 |
| Participants With Benign Meningiomas | 26 |
| Group | Value (days) |
|---|---|
| SOM230C | 124 |
| Group | Value (percentage of participants) |
|---|---|
| Participants With Atypical/Malignant Meningiomas | 45 |
| Participants With Benign Meningiomas | 73 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| SOM230CMonthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial) SOM230C: Injection in the buttocks every 28 days | – | 7 / 34 | 34 / 34 |
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