Clinical trial · Interventional
Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)
A Phase 1b, Open-Label Study of Sorafenib With BIIB022 in Subjects With Advanced Hepatocellular Carcinoma
NCT00956436CI-TRIAL-00012075completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIIB022 | Drug | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sorafenib Monotherapy
- description
- Sorafenib Monotherapy
- interventionNames
- Drug: Sorafenib
- type
- EXPERIMENTAL
- label
- Sorafenib with BIIB022
- description
- Sorafenib with BIIB022
- interventionNames
- Drug: BIIB022
Primary outcomes (1)
- measure
- To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.
- timeFrame
- 6 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST. * Child-Pugh score A5 or A6. * ECOG Performance Status of ≤2. Exclusion Criteria: * Known central nervous system or brain metastases. * Prior anti-IGF-1R therapy. * Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if subjects have documented disease progression according to modified RECIST. * Concurrent anticancer therapy. * History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure. * Acute hepatitis * Fibrolamellar HCC Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.