Phase 3 Study of BGB-A317 Versus Sorafenib in Patients With Unresectable HCC



Status:Recruiting
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:December 28, 2017
End Date:May 2022
Contact:Jeannie Hou, Senior Director
Email:clinicaltrials@beigene.com
Phone:1 (877) 828-5568

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RATIONALE-301: A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma

This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the
efficacy and safety of BGB-A317 versus sorafenib as a first-line systemic treatment in
patients with unresectable hepatocellular carcinoma. This study also includes a substudy
investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese
patients. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In
Substudy) before Japanese patients are recruited in this Phase 3 study.


Inclusion Criteria:

- 1. Histologically confirmed diagnosis of HCC

2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or
progressing after loco-regional therapy and not amenable to a curative treatment
approach

3. No prior systemic therapy for HCC (with the exception of HCC patients enrolled in
the safety run-in substudy [Japan only])

4. Measurable disease

5. Child-Pugh score A

6. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1

7. Adequate organ function

Exclusion Criteria:

- 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
histology

2. Tumor thrombus involving main trunk of portal vein or inferior vena cava

3. Loco-regional therapy to the liver within 28 days before randomization

4. Clinical evidence of portal hypertension with bleeding esophageal or gastric
varices at Screening, or within 6 months before randomization

5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring
therapeutic international normalized ratio monitoring (eg, warfarin or similar agents)
at Screening, or within 6 months before randomization/enrollment

6. Presence at Screening of active immune deficiency or autoimmune disease and/or
prior history of any immune deficiency or autoimmune disease that may relapse

7. Patient with any condition requiring systemic treatment with either corticosteroids
(> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication
within 14 days before randomization

8. History of interstitial lung disease or non-infectious pneumonitis, unless induced
by radiation therapy

9. QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450
msec at Screening
We found this trial at
9
sites
Tinley Park, Illinois 60487
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Tinley Park, IL
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Bengbu,
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Boston, MA
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Fullerton, California 92835
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Fullerton, CA
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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Harvey, IL
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460 West 10th Avenue
Kettering, Ohio 45409
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Kettering, OH
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Orange, California 92868
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Orange, CA
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San Antonio, Texas 78229
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San Antonio, TX
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White Plains, NY
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