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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02460991
Other study ID # SOLACE
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date November 2015
Est. completion date June 5, 2017

Study information

Verified date January 2021
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, multicenter study that will be conducted at up to 40 centers in the United States and Outside United States (OUS). Participants in the study will be randomly assigned to receive either ONCO-DOX or sorafenib treatment. This study will evaluate the study participants' outcomes (medical condition) after being treated with ONCO-DOX and compare it to those treated with sorafenib alone.


Description:

This is a prospective, two-arm, stratified then randomized (1:1), open label, controlled, multicenter Phase III trial to evaluate the safety and efficacy of ONCOZENE™ Microspheres loaded with doxorubicin (ONCO-DOX) in comparison with orally administered sorafenib in patients with unresectable, locally-advanced hepatocellular carcinoma (HCC). Patients will be stratified by ECOG Performance Status 0 versus 1, portal vein invasion (yes vs. no), and alpha feto protein <400 versus ≥400. They will then be randomized at each site within each stratum. The study will be conducted at up to 40 centers in the United States, Europe & Asia. Enrolled patients will be randomized with equal allocation by study site. Patients will be followed for two years after the onset of treatment. The study will assess prospectively the efficacy and safety of DEB-TACE (ONCO-DOX) in patients with unresectable, locally-advanced HCC. The primary objective of this study is to compare the overall survival between DEB-TACE (ONCO-DOX) and sorafenib treatment groups.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date June 5, 2017
Est. primary completion date June 5, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Written Informed Consent 2. =18 years of age 3. Diagnosis of HCC 4. Locally advanced HCC 5. Preserved liver function 6. Eastern Cooperative Oncology Group 0 or 1 Exclusion Criteria: 1. Presence of extra-hepatic spread of disease. 2. Macrovascular invasion of lobar portal vein branches or main portal vein. 3. Candidate for surgical resection, transplantation, or local ablation. 4. Prior intra-arterial embolization, chemotherapy or systemic therapy for HCC. 5. Any contraindication for TACE. 6. Platelet count <50,000/mm3 or international normalized ratio >1.5. 7. Previous treatment with anthracycline antibiotics (e.g. Doxorubicin) or sorafenib. 8. Unstable coronary artery disease or recent myocardial infarct (i.e. within 1 year). 9. Known ejection fraction < 50%. 10. Current infections requiring antibiotic therapy. 11. Suffering from a known bleeding disorder. 12. Renal insufficiency (serum creatinine > 2 mg/dL). 13. Aspartate aminotransferase and/or alanine transaminase >5 times upper limit of normal. 14. Presence of advanced liver disease. 15. Any contraindication for doxorubicin administration: 16. Any co-morbid condition or social situation, which has a high likelihood of causing poor compliance with the study protocol or jeopardizes the patient's safety. 17. Patient has another primary tumor, with the exception of conventional basal cell carcinoma, superficial bladder cancer, melanoma in situ, or treated prostate cancer currently without biochemical or radiographic evidence of active disease 18. Participation in a clinical trial of an investigational device or drug within 4 weeks of study entry. 19. Pregnant or breast-feeding patients.

Study Design


Intervention

Device:
DEB-TACE

Drug:
Sorafenib


Locations

Country Name City State
United States University of Maryland Medical Center Baltimore Maryland
United States University of Alabama Hospital Birmingham Alabama
United States MD Anderson Cancer Center Houston Texas
United States University of Southern California Los Angeles California
United States University of Louisville Louisville Kentucky
United States Oregon Health & Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Proportion Achieved Tumor Response The proportion of patients in each group that achieve complete response (CR), partial response (PR), and stable disease (SD) will be presented and compared across treatment groups. 2 years
Other FACT-Hep Quality of Life FACT-Hep quality of life instrument validated in patients with Hepatic cancer. 2 years
Primary Overall Survival Overall survival in HCC subjects with minimum follow-up of subjects to at least one year 1 year
Secondary Time to Progression Time to progression (TTP) determined by radiological assessment using mRECIST criteria 2 years
Secondary Time to Extrahepatic Spread Time to Extrahepatic Spread for each subject 2 years
Secondary Proportion Progression Free Proportion Progression-Free (PPF) at one year 1 year
Secondary Frequency of Treatment Emergent Adverse Events The frequency of treatment emergent adverse events at 30 day, 3, 6, 9, 12, 18, and 24-months following the initial treatment. The proportions of patients in each arm experiencing treatment emergent adverse events will be presented descriptively with the number experiencing the event, the number evaluated, the percentage, and the exact two-sided 95% confidence interval. 2 years
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