Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer

NCT00699374

Last updated date
Study Location
Pfizer Investigational Site
Fountain Valley, California, 92708, United States
Contact
1-800-718-1021

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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

- Histologically-confirmed diagnosis of hepatocellular carcinoma

- presence of measurable disease by radiographic imaging

- Child-Pugh class A

- ECOG PS 0 or 1

- adequate organ function.

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


- Prior treatment with any systemic treatment for hepatocellular carcinoma


- prior local treatment within 4 weeks from entry


- presence of clinically relevant ascites


- severe hemorrhage <4 weeks of starting study treatment


- known HIV or serious acute or chronic illness


- current treatment on another clinical trial


- pregnancy or breastfeeding

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NCT00699374
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer
Official Title  ICMJE A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma
Brief Summary The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.
Detailed Description This study was terminated on April 22th, 2010, based on a higher incidence of serious adverse events in the sunitinib arm compared to the sorafenib arm, and the fact that sunitinib did not meet the criteria to demonstrate that it was either superior or non-inferior to sorafenib in the survival of patients with advanced hepatocellular cancer. Patients on sunitinib who are judged by the investigator as receiving clinical benefit may chose to remain on study and continue treatment with sunitinib until clinical benefit as per the investigator's judgment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Hepatocellular
Intervention  ICMJE
  • Drug: sunitinib malate
    sunitinib capsules at starting dose of 37.5 mg PO daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sunitinib dosing interruptions and/or reductions are allowed based on patient tolerability.
    Other Name: Sutent®
  • Drug: sorafenib
    sorafenib tablets at starting dose of 400 mg PO twice daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sorafenib dosing interruptions and/or reductions are allowed based on patient tolerability.
    Other Name: Nexavar®
Study Arms  ICMJE
  • Experimental: Arm A
    sunitinib arm
    Intervention: Drug: sunitinib malate
  • Active Comparator: Arm B
    sorafenib arm
    Intervention: Drug: sorafenib
Publications *

*   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: January 26, 2012)
1075
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2008)
1200
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically-confirmed diagnosis of hepatocellular carcinoma
  • presence of measurable disease by radiographic imaging
  • Child-Pugh class A
  • ECOG PS 0 or 1
  • adequate organ function.

Exclusion Criteria:

  • Prior treatment with any systemic treatment for hepatocellular carcinoma
  • prior local treatment within 4 weeks from entry
  • presence of clinically relevant ascites
  • severe hemorrhage <4 weeks of starting study treatment
  • known HIV or serious acute or chronic illness
  • current treatment on another clinical trial
  • pregnancy or breastfeeding
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 Australia,   Belgium,   Canada,   China,   France,   Germany,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Philippines,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00699374
Other Study ID Numbers  ICMJE A6181170
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP