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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Monthly SOM230C for Recurrent or Progressive Meningioma

NCTNCT00859040 (opens ClinicalTrials.gov in a new tab)Other id08-266Other idCSOM230CUS09T

Overview

Status
Completed
Phase
Phase 2
Enrollment
34 participants (actual)
Sponsor
Patrick Y. Wen, MD · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Mar 2009
Primary completion
Dec 2011
Completion
Jan 2016
First posted
10 Mar 2009 (estimated)
Last update posted
27 Oct 2017
Conditions
Meningioma

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201220142016
  1. Ph 2

    Monthly SOM230C for Recurrent or Progressive Meningioma

    NCT00859040

    Mar 2009 to Jan 2016

Registry summary

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.

Interventions

  • SOM230CDrug

Arms1

  • Experimental

    SOM230C

    Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 6 Month Progression Free Survival

    Time frame · 6 months

    Registry description

    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 outcomes(5)
  1. Response Rate

    Time frame · 5 years

    Registry description

    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.

  2. Treatment-related Events

    Time frame · 5 years

    Registry description

    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

  3. Median Progression-Free Survival

    Time frame · 5 years

  4. Median Time to Progression

    Time frame · 34 months

    Registry description

    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.

  5. Overall Survival

    Time frame · 34 months

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 6 months

6 Month Progression Free Survival

GroupValue (percentage of patients)
Participants With Atypical/Malignant Meningiomas11
Participants With Benign Meningiomas44
Secondary and other outcome results(5)
Secondary outcomeNumber· 5 years

Response Rate

GroupValue (participants)
Participants With Atypical/Malignant Meningiomas0
Participants With Benign Meningiomas0
Secondary outcomeNumber· 5 years

Treatment-related Events

GroupValue (events)
SOM230C1
Secondary outcomeMedian· 5 years

Median Progression-Free Survival

GroupValue (weeks)
Participants With Atypical/Malignant Meningiomas15
Participants With Benign Meningiomas26
Secondary outcomeMedian· 34 months

Median Time to Progression

GroupValue (days)
SOM230C124
Secondary outcomeNumber· 34 months

Overall Survival

GroupValue (percentage of participants)
Participants With Atypical/Malignant Meningiomas45
Participants With Benign Meningiomas73

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
SOM230CMonthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial) SOM230C: Injection in the buttocks every 28 days–7 / 3434 / 34

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 18 years of age or older * Radiographically measurable disease on contrast-enhanced MRI or CT images * Karnofsky Performance status of 60 or greater * Life expectancy of at least 3 months * Histologically confirmed diagnosis of recurrent or progressive intracranial meningioma(s). This includes benign, atypical, or malignant meningioma; patients with neurofibromatosis type 1 or 2 may participate. Participants without histological confirmation but a classic radiographic picture of meningioma may also enroll. Patients with neurofibromatosis type 2 and a classic radiographic picture of meningioma may also enroll without histological confirmation * At least ten unstained standard (4-5 micron) paraffin slides for immunohistochemistry. Participants who have not had a surgical procedure are exempt from this requirement * Unequivocal evidence for tumor progression by MRI (or CT scan if MRI is contraindicated) * MRI or CT must be performed within 14 days of registration * Patients with malignant meningiomas who require corticosteroids must be on a stable dose for at least 5 days prior to baseline imaging. * For patients who have been treated with external beam radiation, interstitial brachytherapy, or radiosurgery, an interval of 4 or more weeks must have elapses from the completion of radiation therapy to study drug administration, and there must be evidence of tumor progression. * There is no limit on the number of prior therapies Exclusion Criteria: * Any cytotoxic chemotherapy, radiation, immunotherapy, or experimental therapy within 4 weeks prior to study drug administration * Prior therapy with somatostatin, andy somatostatin analogue, or any other hormonal treatment prescribed for the purpose of treating meningioma * Major surgery within 4 weeks prior to study drug administration * Malabsorption syndrome, short bowel or chologenic diarrhea not controlled by specific therapeutic means * Poorly controlled diabetes mellitus * Symptomatic cholelithiasis * Congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment * QTc \> 450 msec * Risk factors for Torsades de Pointes such as hypokalemia (\< 3.5 mmol/L) not corrected by treatment, hypomagnesemia (\< 0.7 mmol/L or \< 1.6 mg/dL) not corrected by treatment, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block * Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure * Concomitant medication(s) known to increase the QT interval within 4 weeks prior to study drug administration * Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis with serum bilirubin \> 2x ULN, serum albumin \< 0.67 LLN, or ALT or AST more than 2 x ULN * Any other primary malignancy within the past 3 years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix) * Active or suspected acute or chronic, uncontrolled infection or any history of immunocompromise, including any positive HIV test result * Abnormal coagulation studies (PT or PTT elevated by 30% above normal limits) * Use of anticoagulant medications (not including anti-platelet medications) * Lab values as specified in the protocol * Any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator * Pregnancy or lactation, or failure to practice a medically acceptable method of birth control * History of alcohol or drug abuse in the 6 month period before study enrollment * Participation in any clinical investigation with an investigational drug within 1 month prior to study drug administration * Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR os s.c. formulations

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