Phase 1b/2 Study of Oprozomib in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma



Status:Withdrawn
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2014
End Date:March 2015

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The purpose of Phase 1b of the study is to determine the maximum tolerated dose,
pharmacokinetics (PK) and pharmacodynamics (PDn) and assess the safety, tolerability and
activity of oprozomib in combination with sorafenib in subjects with advanced hepatocellular
carcinoma (HCC).

The purpose of Phase 2 of the study is to evaluate the efficacy of oprozomib in combination
with sorafenib versus sorafenib alone and to compare the key outcome measures for subjects
with advanced HCC.


Key Inclusion Criteria:

1. Patients with advanced HCC

2. For the Phase 2 portion of the study, at least 1 measurable tumor lesion according to
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, which has not been
previously treated with local therapy

3. Cirrhotic status of Child-Pugh Class A only

4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

5. The following laboratory parameters:

- Albumin ≥ 2.8 g/dL

- Platelet count ≥ 60,000/mm3

- Absolute neutrophil count (ANC) ≥ 1500/mm3

- Hemoglobin ≥ 8.5 g/dL

- Total bilirubin ≤ 3 mg/dL

- Alanine aminotransaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 times
upper limit of normal (ULN)

- Amylase and lipase ≤ 1.5 times ULN

- Calculated or measured creatinine clearance (CrCl) ≥ 30 mL/min

- Prothrombin time (PT)-international normalized ratio (INR) ≤ 2.3 or PT ≤ 6
seconds above control

Key Exclusion Criteria:

1. Previous or concurrent cancer that is distinct in primary site or histology from HCC,
EXCEPT cervical and breast carcinoma in situ, adequately treated basal cell or
squamous cell carcinoma of the skin, or superficial bladder tumors (Ta, Tis & T1)

2. Renal failure requiring hemo- or peritoneal dialysis

3. History of cardiac disease

4. Active clinically serious infections. Hepatitis B is allowed if no active replication
is present. Hepatitis C is allowed if no antiviral treatment is required

5. Known history of human immunodeficiency virus (HIV) infection

6. Known history or symptomatic metastatic brain or meningeal tumors

7. Clinically significant gastrointestinal (GI) bleeding, serious nonhealing wound and
ulcer within 3 months prior to study entry, or bone fracture within 30 days prior to
study entry

8. History of organ allograft

9. Known or suspected allergy to the investigational agent or any agent given in
association with this trial

10. Inability to swallow medication, inability or unwillingness to comply with the drug
administration requirements, or GI condition that could interfere with the oral
absorption or tolerance of treatment

11. Uncontrolled diabetes

12. Any contraindication to oral hydration (e.g., preexisting cardiac impairment or fluid
restriction)

13. Uncontrolled ascites

14. Pleural effusion or ascites that causes respiratory compromise (NCI-CTCAE ≥ Grade 2
dyspnea).

15. Women who are pregnant and/or breastfeeding

16. Prior use of any systemic anticancer chemotherapy for HCC

17. Prior use of systemic investigational agents for HCC

18. Concomitant treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors

19. Known hypersensitivity or intolerance to dexamethasone or 5-HT3 antagonist
We found this trial at
6
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Burlington, California
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Denver, Colorado 80218
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