Trial · NCT00859040
Monthly SOM230C for Recurrent or Progressive Meningioma
NCT00859040, Phase 2, Completed, Patrick Y. Wen, MD; results first posted 2014-05-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Monthly SOM230C for Recurrent or Progressive Meningioma. Trials, record NCT00859040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00859040
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Monthly SOM230C for Recurrent or Progressive Meningioma
- NCT number
- NCT00859040
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Patrick Y. Wen, MD
- Conditions
- Meningioma
- Interventions
- SOM230C
- First posted
- 2009-03-10
- Last updated
- 2017-10-27
- Results first posted
- 2014-05-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6 Month Progression Free Survival | 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). |
| Secondary | Response Rate | 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. |
| Secondary | Treatment-related Events | 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 |
| Secondary | Median Progression-Free Survival | 5 years | |
| Secondary | Median Time to Progression | 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. |
| Secondary | Overall Survival | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 6 Month Progression Free Survival | 6 months | percentage of patients | NUMBER | |
| SECONDARY | Response Rate | 5 years | participants | NUMBER | |
| SECONDARY | Treatment-related Events | 5 years | events | NUMBER | |
| SECONDARY | Median Progression-Free Survival | 5 years | weeks | MEDIAN | |
| SECONDARY | Median Time to Progression | 34 months | Time to progression only reported for the 32 patients who have progressed (either on treatment or in follow-up).~\[NOTE: The other 2 patients who were treated on study each remain progression-free after \> 1000 days.\] | days | MEDIAN |
| SECONDARY | Overall Survival | 34 months | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 6 Month Progression Free Survival | Participants With Atypical/Malignant Meningiomas | 11 | percentage of patients | ||
| 6 Month Progression Free Survival | Participants With Benign Meningiomas | 44 | percentage of patients | ||
| Response Rate | Participants With Atypical/Malignant Meningiomas | 0 | participants | ||
| Response Rate | Participants With Benign Meningiomas | 0 | participants | ||
| Treatment-related Events | SOM230C | Amylase | 1 | events | |
| Treatment-related Events | SOM230C | Fatigue | 2 | events | |
| Treatment-related Events | SOM230C | Hyperglycemia | 8 | events | |
| Treatment-related Events | SOM230C | Hypoglycemia | 1 | events | |
| Treatment-related Events | SOM230C | Hypokalemia | 1 | events | |
| Treatment-related Events | SOM230C | Lipase | 3 | events |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants With Atypical/Malignant Meningiomas | 18 | |
| Overall Study | STARTED | Participants With Benign Meningiomas | 16 | |
| Overall Study | COMPLETED | Participants With Atypical/Malignant Meningiomas | 18 | |
| Overall Study | COMPLETED | Participants With Benign Meningiomas | 16 | |
| Overall Study | NOT COMPLETED | Participants With Atypical/Malignant Meningiomas | 0 | |
| Overall Study | NOT COMPLETED | Participants With Benign Meningiomas | 0 |
Source ClinicalTrials.gov
Adverse events85
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hearing w/o audiogr not in monitor prg | Ear and labyrinth disorders | SOM230C | 2 | 34 | |
| other | Tinnitus | Ear and labyrinth disorders | SOM230C | 2 | 34 | |
| other | Hemoglobin | Blood and lymphatic system disorders | SOM230C | 7 | 34 | |
| other | Leukocytes | Blood and lymphatic system disorders | SOM230C | 3 | 34 | |
| other | Neutrophils | Blood and lymphatic system disorders | SOM230C | 3 | 34 | |
| other | Platelets | Blood and lymphatic system disorders | SOM230C | 4 | 34 | |
| other | QTc interval | Cardiac disorders | SOM230C | 2 | 34 | |
| other | Sinus bradycardia | Cardiac disorders | SOM230C | 2 | 34 | |
| other | Hypotension | Cardiac disorders | SOM230C | 3 | 34 | |
| other | Constitutional - Other | General disorders | SOM230C | 3 | 34 |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SOM230C | ||
| Total, other adverse events | SOM230C | 34 | 34 |
| Total, serious adverse events | SOM230C | 7 | 34 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Participants With Atypical/Malignant Meningiomas vs Participants With Benign Meningiomas: Response Rate |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00859040
GET https://conductscience.org/api/trials/v1/NCT00859040/events?page=2