An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer

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NCT00247676

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Study Location
Pfizer Investigational Site
Clichy Cedex, , 92118, France
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Liver Neoplasms, Unresectable 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

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


- 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

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Liver Neoplasms, Unresectable Hepatocellular CarcinomaAn International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer
NCT00247676
  1. Clichy Cedex,
  2. Rennes Cedex,
  3. Saint Herrblain Cedex,
  4. Seoul,
  5. Seoul,
  6. Seoul,
  7. Seoul,
  8. Taipei,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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