Phase II Trial of SOM230 in Patients With Unresectable Hepatocellular Carcinoma

NCT01639352 | Completed Phase 2 Results DMC

• 1 other identifier: 20100650
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; HCC; SOM230; Pasireotide LAR

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR)

  The disease-control rate (DCR) is defined as the proportion of participants achieving a best overall response of complete response (CR), partial response or stable disease (SD) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by MRI or CT Scan, and that is maintained for at least 8 weeks. CR is defined as disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

  At least 2 cycles, about 8 weeks

Secondary Outcomes (5)

• Rate of Progression-Free Survival (PFS):

  From Enrollment Until Study Completion, Approximately 3 Years

• Rate of Overall Survival (OS)

  From Enrollment Until Study Completion, Approximately 3 Years

• Overall Response Rate (ORR)

  Up to 2 Years

• Duration of Overall Response

  Up to 2 Years

• Toxicity Profile of Protocol Therapy

  Up to 2 Years

Study Arms (1)

SOM230

EXPERIMENTAL

60mg of SOM230 via injection intramuscularly every 28 days

Biological: SOM230

Interventions

SOM230 BIOLOGICAL

Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days.

Also known as: Pasireotide LAR, SOM230C

SOM230

Eligibility Criteria

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

You may qualify if:

• Diagnosis of unresectable HCC by either:
• Histopathology or
• Elevated serum Alpha-fetoprotein (AFP) \>400 ng/ml and findings on magnetic resonance imaging (MRI) or CT scans characteristic of a primary liver tumor.
• Findings on MRI or CT scans characteristic of a primary liver tumor in patients with cirrhosis
• Tumors at least 1 cm or greater
• Age ≥ 18 years.
• Minimum of four weeks since any major surgery, completion of radiation,or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy).
• Patients may have progressed on sorafenib or refused or were intolerant of sorafenib. A maximum of 2 prior lines of systemic therapy (including chemotherapy or targeted therapy) will be allowed. Prior locoregional therapy such as surgery, radiofrequency ablation or transarterial chemoembolization are also allowed (these will not be counted as systemic therapy), provided that progression has been documented after these therapies, and at least 4 weeks have elapsed since the last therapy.
• Karnofsky performance status (KPS) of 80 or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy 12 weeks or more.
• Adequate bone marrow function as shown by: Absolute neutrophil count (ANC) ≥ 1.2 x 10\^9/L, Platelets ≥ 50 x 10\^9/L
• Adequate liver function as shown by: serum bilirubin \< 1.5x upper limit of normal (ULN) and serum transaminases activity ≤ 3 x ULN. Serum PT =\< 16 seconds.
• Adequate renal function as shown by serum creatinine ≤ 1.5 x ULN.
• Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation (can start after one day of initiation of lipid lowering drug) of appropriate lipid lowering medication.
• Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of the administration of the first study treatment. Women must not be lactating. Both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study.

You may not qualify if:

• Prior octreotide therapy or any somatostatin analog.
• Chronic treatment with systemic steroids or another immunosuppressive agent.
• Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry (ie. within 1 week of signing the informed consent).
• Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
• 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 uncontrolled diabetes mellitus (defined as HgA1c \> 7% or =8% despite therapy) 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 who are at high risk for cardiac arrhythmias as defined by any of the following:
• Baseline QTcF \> 470 msec
• History of syncope or family history of idiopathic sudden death or long QT syndrome
• Sustained or clinically significant cardiac arrhythmias
• Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade atrioventricular block (AV) block
• Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by uncontrolled diabetes, or Parkinson's disease), HIV, uncontrolled hypothyroidism or cardiac failure
• Concomitant medication(s) known to increase the QT interval (see Appendix II)

Sponsors & Collaborators

• Lynn Feun: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Lynn Feun, M.D.
• Organization: University of Miami

lfeun@med.miami.edu

305-243-4909

Study Officials

• Lynn Feun, MD

  University of Miami Sylvester Comprehensive Cancer Center

  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 INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: July 12, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: February 1, 2017
• Last Updated: July 12, 2017
• Results First Posted: July 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)