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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: PF-03446962; Other: Placebo; Other: Best Supportive Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01911273

2013-001426-26 (EudraCT Number)

A8471005

Details and patient eligibility

About

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.

Full description

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

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3 participants in 2 patient groups, including a placebo group

PF 03446962 plus best supportive care (BSC)

Experimental group

Treatment:

Other: Best Supportive Care

Other: Best Supportive Care

Drug: PF-03446962

Placebo plus best supportive care (BSC)

Placebo Comparator group

Description:

Placebo, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first

Treatment:

Other: Best Supportive Care

Other: Best Supportive Care

Other: Placebo