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Trial record 1 of 1 for:    00813592
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Phase II Study of SOM230 in Patients With Recurrent or Progressive Meningioma

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ClinicalTrials.gov Identifier: NCT00813592
Recruitment Status : Terminated (Original PI left and company withdrew support.)
First Posted : December 23, 2008
Results First Posted : May 12, 2014
Last Update Posted : June 11, 2014
Information provided by (Responsible Party):
University of Utah

Brief Summary:

This is a single-arm, phase II trial of SOM230 in patients with documented recurrent or progressive intracranial meningioma who have failed conventional therapy and are not candidates for complete surgical resection of their tumors and/or radiation at the time of study entry.

At the time of the final analysis, all patients who are receiving treatment with SOM230 will complete the core phase of the study and will continue on the extension phase. During this time, additional data on response duration, PFS, and safety will be collected.

Condition or disease Intervention/treatment Phase
Cancer Drug: SOM230B Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of SOM230 in Patients With Recurrent or Progressive Meningioma Who Have Previously Undergone or Are Not Candidates for Additional Surgery or Radiation
Study Start Date : November 2008
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Pasireotide

Arm Intervention/treatment
Experimental: All participants Drug: SOM230B
SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
Other Name: Pasireotide

Primary Outcome Measures :
  1. Objective Response Rate (ORR) of SOM230 Monotherapy in Meningioma [ Time Frame: November 2011 ]
    Measured the percentage of participants achieving a complete response or partial response as opposed to those participants with progressive disease or stable disease.

Secondary Outcome Measures :
  1. To Determine the Duration of Response to SOM230 [ Time Frame: November 2011 ]
  2. To Establish the 6-month Progression-free Survival Rate [ Time Frame: November 2011 ]
  3. To Establish the Median PFS and Overall Survival (OS) [ Time Frame: November 2011 ]
  4. To Determine the Clinical Benefit Rate (CR + PR + Stable Disease) of SOM230 [ Time Frame: November 2011 ]
  5. To Characterize the Safety and Tolerability of SOM230 [ Time Frame: Monthly from study entry until subject taken off study, average 28 months ]
    Number of participants to experience adverse events

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Inclusion Criteria:

  1. Male or female patients aged 18 years or greater.
  2. Patients with radiographically measurable disease and histologically confirmed recurrent or progressive intracranial meningiomas (refer to Appendix 1) who are not candidates for complete surgical resection of their tumors because the tumors are in eloquent areas of the brain (near critical neural structures)or are not candidates for cranial irradiation because a) they have already received radiation or b) the tumor is in close proximity to the optic nerve and radiation would likely result in vision damage.
  3. Karnofsky Performance Status ≥ 60 (Requires occasional assistance, but is able to care for most of his/her personal needs.)
  4. The following labs must not be clinically significant, as determined by PI. (Albumin, alkaline phosphatase, calcium, chloride, potassium, total protein, and sodium,)
  5. Serum chemistries are as follows: bilirubin ≤ 1.5 X ULN, ALT or AST ≤ 2.5 X ULN, BUN ≤ 1.5X ULN, creatinine ≤ 1.5 X ULN.
  6. Signed informed consent

Exclusion Criteria:

  1. Patients receiving any cytotoxic chemotherapy, radiation or immunotherapy within 4 weeks prior to study enrollment
  2. Patients who have undergone major surgery within 4 weeks(other than diagnostic surgery) or have not fully recovered, prior to study enrollment
  3. Patients with malabsorption syndrome, short bowel syndrome, or chologenic diarrhea not controlled by specific therapeutic means
  4. Patients with uncontrolled diabetes mellitus or a fasting plasma glucose > 1.5 ULN. Note: At the principle investigator's discretion, non-eligible patients can be re-screened after adequate medical therapy has been instituted.
  5. Patients with symptomatic cholelithiasis
  6. Patients who have congestive heart failure (NYHA Class III or IV), 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.
  7. Patients with congenital QTc syndrome, drug-induced prolonged QTc interval, or QTc measurement > 450 msec.
  8. Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis with serum bilirubin > 1.5 X ULN, and/ or ALT or AST > 2.5 X ULN
  9. Patients with prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five years.
  10. Patients with active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result (ELISA and Western blot).
  11. Patients with ANC <1.5 X 109/L; Hgb <10 g/dL; PLT <100 X 109/L
  12. Patients who have any current or prior medical condition that, in the opinion of the Investigator, may interfere with the conduct of the study, the evaluation of its results, or the rigorous completion of the informed consent process.
  13. Female patients who are pregnant or lactating, or adults of childbearing potential who are not practicing a medically acceptable method of birth control. Female patients must use barrier contraception in addition to condom use in their partner. If oral contraception is used, the patient must have been practicing this method for at least two months prior to enrollment and must agree to continue the oral contraceptive throughout the course of the study, and for three months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three months afterward.
  14. Patients who have participated in any clinical investigation with an investigational drug (other than SOM230) within 1 month prior to study drug dosing.
  15. Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR or s.c. formulations (see section 6.1.1)
  16. Patients with a history of non-adherence to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
  17. QTcF at screening > 450 msec.
  18. History of syncope or family history of idiopathic sudden death.
  19. Sustained or clinically significant cardiac arrhythmias.
  20. Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block.
  21. 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.
  22. Concomitant medication (s) known to increase the QT interval.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813592

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United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
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Principal Investigator: Randy Jensen, MD University of Utah
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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00813592    
Other Study ID Numbers: HCI26519
First Posted: December 23, 2008    Key Record Dates
Results First Posted: May 12, 2014
Last Update Posted: June 11, 2014
Last Verified: June 2014
Keywords provided by University of Utah:
Additional relevant MeSH terms:
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Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs