Phase II Study of SOM230 in Patients With Recurrent or Progressive Meningioma

NCT00813592 | Terminated Phase 2 Results DMC

• 1 other identifier: HCI26519
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

meningioma; brain

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) of SOM230 Monotherapy in Meningioma

  Measured the percentage of participants achieving a complete response or partial response as opposed to those participants with progressive disease or stable disease.

  November 2011

Secondary Outcomes (5)

• To Determine the Duration of Response to SOM230

  November 2011

• To Establish the 6-month Progression-free Survival Rate

  November 2011

• To Establish the Median PFS and Overall Survival (OS)

  November 2011

• To Determine the Clinical Benefit Rate (CR + PR + Stable Disease) of SOM230

  November 2011

• To Characterize the Safety and Tolerability of SOM230

  Monthly from study entry until subject taken off study, average 28 months

Study Arms (1)

All participants

EXPERIMENTAL

Drug: SOM230B

Interventions

SOM230B DRUG

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.

Also known as: Pasireotide

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 18 years or greater.
• 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.
• Karnofsky Performance Status ≥ 60 (Requires occasional assistance, but is able to care for most of his/her personal needs.)
• The following labs must not be clinically significant, as determined by PI. (Albumin, alkaline phosphatase, calcium, chloride, potassium, total protein, and sodium,)
• 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.
• Signed informed consent

You may not qualify if:

• Patients receiving any cytotoxic chemotherapy, radiation or immunotherapy within 4 weeks prior to study enrollment
• Patients who have undergone major surgery within 4 weeks(other than diagnostic surgery) or have not fully recovered, prior to study enrollment
• Patients with malabsorption syndrome, short bowel syndrome, or chologenic diarrhea not controlled by specific therapeutic means
• 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.
• Patients with symptomatic cholelithiasis
• 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.
• Patients with congenital QTc syndrome, drug-induced prolonged QTc interval, or QTc measurement \> 450 msec.
• 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
• 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.
• 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).
• Patients with ANC \<1.5 X 109/L; Hgb \<10 g/dL; PLT \<100 X 109/L
• 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.
• 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.
• Patients who have participated in any clinical investigation with an investigational drug (other than SOM230) within 1 month prior to study drug dosing.
• Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR or s.c. formulations (see section 6.1.1)

Sponsors & Collaborators

• University of Utah: lead
• Novartis: collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Neoplasms; Meningioma

Interventions

pasireotide

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Randy Jensen, MD, PhD
• Organization: Huntsman Cancer institute

randy.jensen@hci.utah.edu

801-585-0255

Study Officials

• Randy Jensen, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: December 23, 2008
• Study Start: November 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 11, 2014
• Results First Posted: May 12, 2014

Record last verified: 2014-06

Locations

US (1)