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
| Status: | Terminated |
|---|---|
| Conditions: | Liver Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2013 |
| End Date: | July 2014 |
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
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.
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.
This study was terminated on June 24th, 2014 due to change in strategy of PF-03446962
clinical development. There were no safety or efficacy concerns regarding the study behind
the decision to terminate the trial. The study was on temporary halt since March 10th and
there are currently no patients on treatment or in the process of being randomized
clinical development. There were no safety or efficacy concerns regarding the study behind
the decision to terminate the trial. The study was on temporary halt since March 10th and
there are currently no patients on treatment or in the process of being randomized
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
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