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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Clichy Cedex, , 92118 France
Contact
1-800-718-1021
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

- 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

NCT00247676
Pfizer
Completed
An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer

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An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer
An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma
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
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Liver Neoplasms
  • Unresectable Hepatocellular Carcinoma
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
Experimental: A
Intervention: Drug: Sunitinib (SU011248)


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
February 2009
February 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Korea, Republic of,   Taiwan
Greece,   Hong Kong
 
NCT00247676
A6181055
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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