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A Phase II Trial of OSI-906 and Sorafenib in Advanced Hepatocellular Cancer

Phase 2
18 Years
Not Enrolling
Liver Cancer

Thank you

Trial Information

A Phase II Trial of OSI-906 and Sorafenib in Advanced Hepatocellular Cancer

The purpose of the trial is first to evaluate the safety of the combination of OSI-906 and
sorafenib in patients with 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 patietns) 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 wil
be taken off trial.

The trial willl collect blood samples to evalute the level of the investigaitonal agent in
the blood. Also samples of the patients tumor will be analyzed to evalute for markers that
may predict who benefits from treatment.

Inclusion Criteria:

- 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 (See Appendix B)

- Performance status of 0-2. (See Appendix C)

- Organ function requirements: hemoglobin > 9.0mg/dl; granulocyte count > 1,000 /mm3 ,
platelets > 40,000/mm3 , ALT/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

- 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.

Exclusion Criteria:

- 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.

- QTc interval > 450 msec at baseline;

- Concomitant drugs that prolong the QTc interval;

- Significant cardiac disease defined as: congestive heart failure (NYHA class 2 or
higher- See Appendix D) 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

- 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) ('Torsades
List' on, see Appendix E) 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)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of MRI/CT Scans to Pre-treatment Scan

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Bassel El-Rayes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

March 2011

Completion Date:

December 2011

Related Keywords:

  • Liver Cancer
  • Liver cancer
  • Liver Neoplasms



University of Michigan Ann Arbor, Michigan  48109-0624
Ohio State University Columbus, Ohio  43210
Emory University Winship Cancer Institute Atlanta, Georgia  30322