Liver CancerPhase 2NCT01334710
A Phase II Trial of OSI-906 and Sorafenib in Advanced Hepatocellular Cancer
A Phase 2 study testing Sorafenib and OSI-906 in people with Liver Cancer, run by Emory University at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the effect of combining a new investigational drug (OSI-906) with a standard drug (sorafenib) on the control of liver cancer (hepatocellular cancer). Sorafenib (brand name Nexavar®) is a drug that is approved for the treatment of advanced liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Sorafenib and OSI-906
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2011to Dec 2011
- 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
- Patients with measurable, histological diagnosis of HCC and whose disease is not amenable to surgical or regional therapy.
- Prior allowed therapy: surgery, regional therapy (if more than 6 weeks have elapsed from therapy and if there is an indicator lesion outside the treated area or if there is clear evidence of progression in the treated lesion), or adjuvant sorafenib (if disease relapsed more than 6 months after completion of adjuvant therapy).
- Patient with cirrhosis must have Childs-Pugh score of either A or B7.
- Performance status of 0-2.
- Organ function requirements: hemoglobin > 9.0mg/dl; granulocyte count > 1,000 /mm³ , platelets > 40,000/mm³ , alanine aminotransferase (ALT)/aspartate aminotransferase (AST) up to 5 times the institutional upper limit of normal, alkaline phosphatase < 4 times the institutional upper limit of normal and serum creatinine < 2mg/dl.
- Patients must provide verbal and written informed consent to participate in the study.
- Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
Who cannot join
- Patients with mixed histology or fibrolamellar variant.
- Fasting glucose >150 mg/dl and any prior history of diabetes.
- Patients with Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy.
- Prior systemic therapy for metastatic disease.
- Corrected QT (QTc) interval > 450 msec at baseline.
- Concomitant drugs that prolong the QTc interval.
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- Significant cardiac disease defined as: congestive heart failure (NYHA class 2 or higher) or active coronary artery disease (MI within 6 months of study enrollment).
- Pregnant or breast-feeding females.
- Serious active infections.
- Encephalopathy.
- Uncontrolled ascites defined as symptomatic ascites not controlled with diuretic treatments.
- Active second primary malignancy except for is situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin within less than one year of enrollment into the study.
- Use of drugs that have a known risk of causing Torsades de Pointes (TdP) are prohibited within 14 days prior to enrollment.
- Use of the potent CYP1A2 inhibitors such as ciprofloxacin and fluvoxamine. Other less potent CYP1A2 inhibitors/inducers are not excluded.
- Patients with a history of poorly controlled gastrointestinal disorders that could affect the absorption of study drug (e.g., Crohn's disease, ulcerative colitis, etc).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
Ohio State University
Columbus, Ohio, 43210
About this study
The purpose of this study is to evaluate the effect of combining a new investigational drug (OSI-906) with a standard drug (sorafenib) on the control of liver cancer (hepatocellular cancer). Sorafenib (brand name Nexavar®) is a drug that is approved for the treatment of advanced liver cancer. It works by stopping the growth of new blood vessels around the tumor. OSI-906 is an investigational agent that works by inhibiting the effects of a growth hormone on the cancer. The safety and efficacy of combining OSI-906 and sorafenib in the treatment of liver cancer risk not known. The current study will confirm the safety of the combination in the first six patients and evaluate the activity of the combination in patients with advanced liver cancer.
In addition, the study will aim at collecting blood samples from patients to evaluate the level of OSI-906 in patients receiving the combination of the two drugs. The study also will collect samples of the tumor to evaluate for markers that can predict in which patient the combination is effective.
Read the detailed description
The purpose of the trial is first to evaluate the safety of the combination of OSI-906 and sorafenib in patients with hepatocellular cancer (HCC). Patients will be treated in groups of three with full dose sorafenib and OSI-906. If we do not observe any significant side effects, then three additional patients will be treated at the same dose level. After confirming the safety of the combination (possibly after first six patients) the study will proceed with regular accrual. The patients will receive the treatments orally and will be evaluated by physical exam, blood work and imaging. If the cancer is well controlled and the therapy is well tolerated then patients will continue on the trial. If the side effects are significant or the tumor starts to grow or the patients wishes to stop therapy the patient at that time will be taken off trial.
The trial will collect blood samples to evaluate the level of the investigational agent in the blood. Also samples of the patients tumor will be analyzed to evaluate for markers that may predict who benefits from treatment.
- Conditions
- Liver Cancer
- Being tested
- Sorafenib and OSI-906
- Keywords
- Liver cancer
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib and OSI-906Drug
Also called Nexavar
Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib and OSI-906 | Experimental | This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients. Receives: Drug: Sorafenib and OSI-906 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of MRI/CT Scans to Pre-treatment Scan
Efficacy will be measured by evaluating the number of patients who do not have disease progression (measured by CT or MRI scan) 5 months after starting treatment. Assessment of the endpoint of disease progression will be performed every 2 months using either CT or MRI scan. Participants will remain on the study until either evidence of disease progression or unacceptable side effects develop. This period is expected to be on the average 6 months long.
Measured: 6 months
Secondary outcomes (1)
Toxicity Assessment
Evaluate the proportion of participants treated with OSI-906 and sorafenib who develop serious adverse events.
Measured: 28 days from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2011
- Study completionDec 2011
Why it stopped: safety issue observed on another hepatocellular study using OSI906
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 Liver CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- OSI Pharmaceuticals
- Responsible party
- Principal investigator, Bassel El-Rayes, Emory University
- Investigators
- Bassel El-Rayes, MD, Principal investigator, Emory University Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334710
- Sponsor's protocol ID
- IRB00047003
- Other IDs
- WCI1887-10
- Status last verified
- Oct 2017
- First submitted
- 6 Apr 2011
- Last updated
- 21 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of OSI-906 and Sorafenib in Advanced Hepatocellular Cancer
- ClinicalTrials.gov ID
- NCT01334710
- Acronym / sponsor ID
- IRB00047003
- Conditions
- Liver Cancer
- Keywords
- Liver cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: safety issue observed on another hepatocellular study using OSI906
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- OSI Pharmaceuticals
- Study start
- Mar 2011 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Apr 2011 (estimated)
- Results
- Posted 12 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of combining a new investigational drug (OSI-906) with a standard drug (sorafenib) on the control of liver cancer (hepatocellular cancer). Sorafenib (brand name Nexavar®) is a drug that is approved for the treatment of advanced liver cancer. It works by stopping the growth of new blood vessels around the tumor. OSI-906 is an investigational agent that works by inhibiting the effects of a growth hormone on the cancer. The safety and efficacy of combining OSI-906 and sorafenib in the treatment of liver cancer risk not known. The current study will confirm the safety of the combination in the first six patients and evaluate the activity of the combination in patients with advanced liver cancer.
In addition, the study will aim at collecting blood samples from patients to evaluate the level of OSI-906 in patients receiving the combination of the two drugs. The study also will collect samples of the tumor to evaluate for markers that can predict in which patient the combination is effective.
Detailed description
The purpose of the trial is first to evaluate the safety of the combination of OSI-906 and sorafenib in patients with hepatocellular cancer (HCC). Patients will be treated in groups of three with full dose sorafenib and OSI-906. If we do not observe any significant side effects, then three additional patients will be treated at the same dose level. After confirming the safety of the combination (possibly after first six patients) the study will proceed with regular accrual. The patients will receive the treatments orally and will be evaluated by physical exam, blood work and imaging. If the cancer is well controlled and the therapy is well tolerated then patients will continue on the trial. If the side effects are significant or the tumor starts to grow or the patients wishes to stop therapy the patient at that time will be taken off trial.
The trial will collect blood samples to evaluate the level of the investigational agent in the blood. Also samples of the patients tumor will be analyzed to evaluate for markers that may predict who benefits from treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib and OSI-906 | Experimental | Drug: Sorafenib and OSI-906This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with measurable, histological diagnosis of HCC and whose disease is not amenable to surgical or regional therapy.
- Prior allowed therapy: surgery, regional therapy (if more than 6 weeks have elapsed from therapy and if there is an indicator lesion outside the treated area or if there is clear evidence of progression in the treated lesion), or adjuvant sorafenib (if disease relapsed more than 6 months after completion of adjuvant therapy).
- Patient with cirrhosis must have Childs-Pugh score of either A or B7.
- Performance status of 0-2.
- Organ function requirements: hemoglobin > 9.0mg/dl; granulocyte count > 1,000 /mm³ , platelets > 40,000/mm³ , alanine aminotransferase (ALT)/aspartate aminotransferase (AST) up to 5 times the institutional upper limit of normal, alkaline phosphatase < 4 times the institutional upper limit of normal and serum creatinine < 2mg/dl.
Key exclusion criteria (15 listed)
- Patients with mixed histology or fibrolamellar variant.
- Fasting glucose >150 mg/dl and any prior history of diabetes.
- Patients with Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy.
- Prior systemic therapy for metastatic disease.
- Corrected QT (QTc) interval > 450 msec at baseline.
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 |
|---|---|---|
| Sorafenib and OSI-906Also: NexavarSorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily | Drug | Sorafenib and OSI-906 |
Primary outcome
Comparison of MRI/CT Scans to Pre-treatment Scan
Time frame: 6 months
Efficacy will be measured by evaluating the number of patients who do not have disease progression (measured by CT or MRI scan) 5 months after starting treatment. Assessment of the endpoint of disease progression will be performed every 2 months using either CT or MRI scan. Participants will remain on the study until either evidence of disease progression or unacceptable side effects develop. This period is expected to be on the average 6 months long.
1 secondary outcome
Toxicity Assessment
Time frame: 28 days from study entry
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bassel El-Rayes, MD principal investigator
Emory University Winship Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib and OSI-906 in people with Liver Cancer, run by Emory University at 3 sites 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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Oct 2012). 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?
Comparison of MRI/CT Scans to Pre-treatment Scan (time frame: 6 months). 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 21 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.