An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer
NCT00247676
Last updated date
ABOUT THIS STUDY
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
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
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
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
- Clichy Cedex,
- Rennes Cedex,
- Saint Herrblain Cedex,
- Seoul,
- Seoul,
- Seoul,
- Seoul,
- 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 |
| |||
| 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 | 37 | |||
| Original Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||