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Trial record 1 of 1 for:    NCT00247676
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An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer

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ClinicalTrials.gov Identifier: NCT00247676
Recruitment Status : Completed
First Posted : November 2, 2005
Results First Posted : February 2, 2010
Last Update Posted : February 18, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 1, 2005
First Posted Date  ICMJE November 2, 2005
Results First Submitted Date  ICMJE January 6, 2010
Results First Posted Date  ICMJE February 2, 2010
Last Update Posted Date February 18, 2010
Study Start Date  ICMJE February 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2010)
  • Best Overall Response [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ]
  • Objective Response (CR or PR) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2005)
Overall confirmed objective response rate
Change History Complete list of historical versions of study NCT00247676 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
  • Duration of Objective Response (CR or PR) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death due to cancer ]
  • Clinical Benefit Response (CR, PR, or SD With Duration ≥12 Weeks) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or SD with duration of at least 12 weeks on study ]
  • Best Overall Response of PR or SD With Duration ≥12 Weeks [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or SD with duration of at least 12 weeks or death due to cancer ]
  • Progression-Free Survival (Overall ITT) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death ]
  • Progression-Free Survival (ITT Child Pugh Class A Subject Population) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death ]
  • Time to Tumor Progression (Overall ITT) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ]
  • Time to Tumor Progression (ITT Child Pugh Class A Subject Population) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ]
  • Overall Survival (Overall ITT) [ Time Frame: From start of study treatment until death. ]
  • Overall Survival (ITT Child Pugh Class A Subject Population) [ Time Frame: From start of study treatment until death. ]
  • 1-Year Survival Probability [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter up until 1 year. ]
  • Trough Plasma Concentrations (Ctrough) of Sunitinib [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ]
  • Ctrough of SU-012662 (Metabolite of Sunitinib) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ]
  • Ctrough of Total Drug (Sunitinib + SU-012662) [ Time Frame: Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ]
  • Dose-Corrected Ctrough of Sunitinib [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ]
  • Dose-Corrected Ctrough of SU-012662 (Metabolite of Sunitinib) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ]
  • Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) [ Time Frame: Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ]
  • Circulating Endothelial Cells (CECs) and Circulating Endothelial Progenitor Cells (CEPs) [ Time Frame: Cycle 1 (Days 1, 14), Cycle 2 (Days 1, 28), Cycle 5 (Day 1) ]
  • Tissue Tumor Markers Assessed by Tumor Biopsy [ Time Frame: Day 28 of Cycle 1 (optional) ]
  • Plasma Concentration of Vascular Endothelial Growth Factor (VEGF) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28) ]
  • Plasma Concentration of VEGF-C [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28) ]
  • Plasma Concentration of Soluble VEGF Receptor-2 (sVEGFR-2) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28) ]
  • Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28) ]
  • Plasma Concentration of Soluble KIT (sKIT) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2005)
Clinical Benefit Rate, Duration of Response, Progression-free survival; Time to progression; Overall survival; Probability of survival at 1 year, safety, pk, biomarkers
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer
Official Title  ICMJE An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma
Brief Summary The study will consist of two parts. In Part 1 the study will start enrolling 38 patients and then further 25 patients up to a total of 63 eligible patients. If the study gives good results it can be expanded to a total of 160 patients. SU011248 will be administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg [milligrams] with provision for dose reduction based on tolerability. All patients will receive repeated cycles of SU011248 until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liver Neoplasms
  • Unresectable Hepatocellular Carcinoma
Intervention  ICMJE Drug: Sunitinib (SU011248)
Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.
Other Name: SU011248, Sutent
Study Arms  ICMJE Experimental: A
Intervention: Drug: Sunitinib (SU011248)
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 Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2009)
37
Original Enrollment  ICMJE
 (submitted: November 1, 2005)
160
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed diagnosis of hepatocellular carcinoma
  • Patients must present with disease not amenable to curative surgery (i.e. either hepatectomy, or liver transplant).
  • Evidence of measurable disease by radiographic technique
  • Adequate organ function.

Exclusion Criteria:

  • Prior treatment with any systemic treatment for liver cancer
  • Presence of clinically relevant ascites
  • Severe hemorrhage <4 weeks of starting study treatment.
  • Diagnosis of second malignancy within last 3 years
  • History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
  • Known human immunodeficiency virus (HIV)
  • Serious acute or chronic illness
  • Current treatment on another clinical trial
  • Pregnant 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 France,   Korea, Republic of,   Taiwan
Removed Location Countries Greece,   Hong Kong
 
Administrative Information
NCT Number  ICMJE NCT00247676
Other Study ID Numbers  ICMJE A6181055
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2010

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