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

NCT01911273 | Terminated Phase 2 Results DMC

• 2 other identifiers: A84710052013-001426-26
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Carcinoma, Hepatocellular

Keywords

Hepatocellular carcinoma; monoclonal antibody; ALK-1; best supportive care

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS was the duration from date of randomization to date of death due to any cause. For participants who are alive, overall survival was censored at the last contact. Death was determined from adverse event (AE) data where outcome was death or from follow-up contact data where the participant current status was death.

  From first randomization to date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization

Secondary Outcomes (12)

• Time to Tumor Progression (TTP)

  Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.

• Progression-Free Survival (PFS)

  Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.

• Objective Response Rate (ORR) - Percentage of Participants With Objective Response

  Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.

• Duration of Response (DR)

  From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization

• Percentage of Participants With Disease Control Rate (DCR) at 16 Weeks

  From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization

Study Arms (2)

PF 03446962 plus best supportive care (BSC)

EXPERIMENTAL

Drug: PF-03446962; Other: Best Supportive Care

Placebo plus best supportive care (BSC)

PLACEBO COMPARATOR

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

Other: Placebo; Other: Best Supportive Care

Interventions

PF-03446962 DRUG

PF 03446962 7 mg/kg, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first

PF 03446962 plus best supportive care (BSC)

Best Supportive Care OTHER

BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life

PF 03446962 plus best supportive care (BSC)

Placebo OTHER

Placebo will consist of Saline (0.9% w/v Sodium Chloride Injection, USP or NS)

Placebo plus best supportive care (BSC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Kinki University Hospital, Department of Gastroenterology and Hepatology

Ōsaka-sayama, Osaka, 589-8511, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

ascrinvacumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Limitations and Caveats

This study was prematurely terminated due to a Sponsor decision not to pursue the clinical development of PF-03446962 as monotherapy in second-line hepatocellular carcinoma.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: July 30, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 28, 2015
• Results First Posted: June 29, 2015

Record last verified: 2015-10

Locations

JP (3); US (1)