Hepatocellular CarcinomaPhase 2NCT01639352
Phase II Trial of SOM230 in Patients With Unresectable Hepatocellular Carcinoma
A Phase 2 study testing SOM230 in people with Hepatocellular Carcinoma, run by Lynn Feun at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- SOM230
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Feb 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information.
- Child's A and early Child's B (no more than 7 points on the Child Pugh Classification).
- Measurable disease by CT scan with contrast. If evaluable disease or measurable disease has been previously treated, this must show signs of tumor progression by CT. Measurable disease and evaluable disease will be defined by the RECISTguidelines (see section 9.0).
- Patients with cirrhosis either radiologically or pathology with findings either by CT scan or MRI characteristic of primary liver cancer are eligible.
Who cannot join
- 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.
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- 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)
- Patients with the presence of 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 who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
- Severely impaired lung function
- Any active (acute or chronic) or uncontrolled infection/ disorders.
- Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy
- Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to administration of pasireotide). Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.
- Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR formulations
- History of noncompliance to medical regimens
- Patients unwilling to or unable to comply with the protocol or unable to give informed consent.
- Patients with baseline Alanine transaminase (ALT) or Aspartate transaminase (AST) > 3x ULN.
- Patients with baseline serum bilirubin > 1.5 x ULN.
- Prothrombin time (PT) > 16 seconds and/or partial thromboplastin time (PTT) > 1.5 x ULN
- History of or current alcohol misuse/abuse within the past 12 months.
- Known gallbladder or bile duct disease, acute or chronic pancreatitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of SOM230 (Pasireotide LAR) in Patients With Unresectable Hepatocellular Carcinoma (HCC)
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- SOM230
- Keywords
- Hepatocellular Carcinoma, HCC, SOM230, Pasireotide LAR
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOM230Biological
Also called Pasireotide LAR, SOM230C
Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| SOM230 | Experimental | 60mg of SOM230 via injection intramuscularly every 28 days Receives: Biological: SOM230 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At least 2 cycles, about 8 weeks
Secondary outcomes (5)
Rate of Progression-Free Survival (PFS):
Rate of Progression-Free Survival (PFS). PFS will be measured from the date of enrollment to the earliest date of documented disease progression or death from any cause, whichever is earlier. Progression is defined according to RECIST v 1.1 criteria as an at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who remain alive without progression, follow up time will be censored at the date of last disease assessment.
Measured: From Enrollment Until Study Completion, Approximately 3 Years
Rate of Overall Survival (OS)
Rate of Overall Survival (OS) in participants receiving protocol therapy. OS will be measured from the date of enrollment to the date of death or last contact.
Measured: From Enrollment Until Study Completion, Approximately 3 Years
Overall Response Rate (ORR)
Proportion of patients achieving Complete Response and Partial Response (CR+PR) to protocol therapy per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT Scan. 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.
Measured: Up to 2 Years
Duration of Overall Response
Duration of Overall Response in participants achieving complete response (CR) or partial response (PR) to SOM230 treatment. The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Overall response is assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by MRI or CT Scan. 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.
Measured: Up to 2 Years
Toxicity Profile of Protocol Therapy
Number of patients experiencing adverse events and/or toxicities while receiving protocol therapy.
Measured: Up to 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lynn Feun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lynn Feun, University of Miami
- Investigators
- Lynn Feun, MD, Principal investigator, University of Miami Sylvester Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639352
- Sponsor's protocol ID
- 20100650
- Status last verified
- Jun 2017
- First submitted
- 9 Jul 2012
- Last updated
- 12 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of SOM230 (Pasireotide LAR) in Patients With Unresectable Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT01639352
- Acronym / sponsor ID
- 20100650
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, HCC, SOM230, Pasireotide LAR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lynn FeunUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Posted 12 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOM230 | Experimental | Biological: SOM23060mg of SOM230 via injection intramuscularly every 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Diagnosis of unresectable HCC by either:
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOM230Also: Pasireotide LAR, SOM230CPatients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days. | Biological | SOM230 |
Primary outcome
Disease Control Rate (DCR)
Time frame: At least 2 cycles, about 8 weeks
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.
5 secondary outcomes
Rate of Progression-Free Survival (PFS):
Time frame: From Enrollment Until Study Completion, Approximately 3 Years
Rate of Overall Survival (OS)
Time frame: From Enrollment Until Study Completion, Approximately 3 Years
Overall Response Rate (ORR)
Time frame: Up to 2 Years
Duration of Overall Response
Time frame: Up to 2 Years
Toxicity Profile of Protocol Therapy
Time frame: Up to 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn Feun, MD principal investigator
University of Miami Sylvester Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SOM230 in people with Hepatocellular Carcinoma, run by Lynn Feun at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate (DCR) (time frame: At least 2 cycles, about 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.