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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

Last updated on November 12, 2019

FOR MORE INFORMATION
Study Location
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatocellular Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01911273
Pfizer
Terminated
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

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Hepatocellular Carcinoma
NCT03289533
All Genders
20+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionThis 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Hepatocellular
Intervention  ICMJE
  • Drug: PF-03446962
    PF 03446962 7 mg/kg, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first
  • Other: Best Supportive Care
    BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life
  • Other: Placebo
    Placebo will consist of Saline (0.9% w/v Sodium Chloride Injection, USP or NS)
  • Other: Best Supportive Care
    BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.
Study Arms  ICMJE
  • Experimental: PF 03446962 plus best supportive care (BSC)
    Interventions:
    • Drug: PF-03446962
    • Other: Best Supportive Care
  • Placebo Comparator: Placebo plus best supportive care (BSC)
    Placebo, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first
    Interventions:
    • Other: Placebo
    • Other: Best Supportive Care
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 15, 2014)
3
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2013)
180
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion DateJuly 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01911273
Other Study ID Numbers  ICMJE A8471005
2013-001426-26 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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