Clinical trial · Interventional
A Study To Evaluate The Efficacy And Safety of The Investigational Drug PF-03446962 (A Monoclonal Antibody With Antiangiogenic Features) In Combination With Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients Affected By Recurrent Liver Cancer
A Phase 2, Randomized, Double Blind Study To Evaluate The Efficacy, Safety, Pharmacodynamics And Pharmacokinetics Of The Anti-alk-1 Monoclonal Antibody Pf-03446962 In Combination With Best Supportive Care Vs. Placebo Plus Best Supportive Care In Adult Patients With Advanced Hepatocellular Carcinoma Following Failure Of Sorafenib
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): See termination reason in detailed description.
Summary
Brief summary (as posted)
The primary purpose of the study is to explore whether treatment with PF-03446962 and best supportive care is better than placebo plus best supportive care in prolonging survival of patients affected by recurrent liver cancer. In addition, the study will explore if adding PF-03446962 to best supportive care is safe, how PF-03446962 is metabolized, if there are patients' characteristics (biomarkers) that may predict response to PF-03446962, and if PF-03446962 has any effect on the patients' quality of life.
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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Supportive Care | Other | — | UNRESOLVED |
| PF-03446962 | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PF 03446962 plus best supportive care (BSC)
- interventionNames
- Drug: PF-03446962
- Other: Best Supportive Care
- type
- PLACEBO_COMPARATOR
- label
- Placebo plus best supportive care (BSC)
- description
- Placebo, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first
- interventionNames
- Other: Placebo
- Other: Best Supportive Care
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- From first randomization to date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of locally advanced or metastatic liver cancer obtained by histology/cytology or by imaging * Documented progression on or after treatment with sorafenib, confirmed by the Investigator upon review of appropriate imaging documentation * Child Pugh Class A disease * ECOG \[Eastern Cooperative Oncology Group\] Performance Status (PS) 0 or 1 * Mandatory tumor biopsy at study entry (pre-randomization, unless already collected after sorafenib progression but within 3 months of enrollment and no systemic anticancer therapies received) Exclusion Criteria: * Prior systemic treatment for advanced liver cancer other than sorafenib-including therapy * Prior local therapy within 2 weeks of starting the study treatment * Presence of main portal vein invasion by liver cancer
References
Publications (0)
Data not yet available