Spots Global Cancer Trial Database for Phase II Trial of SOM230 in Patients With Unresectable Hepatocellular Carcinoma

Study Description

Brief Summary: The hypothesis of this clinical trial is that hepatocellular carcinomas contain somatostatin receptors which make them sensitive to the inhibitory effects of a new somatostatin analog, SOM230. This analog has greater and broader binding affinity to somatostatin receptors compared to the current drug in use, sandostatin LAR. Thus, SOM230 has the potential to be more effective in the treatment of patients with hepatocellular carcinoma.

Detailed Description: For all patients, SOM230 will be given at a starting dose of 60 mg intramuscularly (IM) every 28 days. Dose reduction will be allowed for toxicities which are deemed to be therapy-related. Patients will receive SOM230C (IM) as an outpatient and will be observed for at least 30 minutes for any immediate adverse reactions. Toxicity checks will be done every 2 weeks and laboratory tests every 4 weeks during study therapy). Safety and efficacy will be assessed throughout the treatment period. Toxicities will be graded using the Common Terminology Criteria for Adverse Events, version 4.02. Therapy will continue for maximum of two years if the patient shows no evidence of disease progression or intolerable toxicity. After completion of all study related therapy patients will complete a 30 day safety follow up visit. Patients who are still benefiting from therapy after two years may continue longer only after discussion between the Principal Investigator (PI) and the drug sponsor.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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