SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
NCT00577382
ABOUT THIS STUDY
FOR MORE INFORMATION
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Pfizer Clinical Trials Contact Center
1-800-718-1021
- History of primary mucosal or acral/lentiginous melanoma
- Histologically documented stage III unresectable or IV metastatic melanoma
- ECOG Performance Status 0,1 or 2
- Estimated life expectancy of 6 months or greater
- 18 years of age or older
- Lab values as outlined in protocol
- Tumor blocks or slides must be available of either primary or metastatic tumor site for c-kit mutation testing
- Negative pregnancy test within 48 hours of starting treatment
- At least one measurable site of disease as defined by at least 1cm in greatest dimension
- Severe and/or uncontrolled medical disease
- Pregnant or nursing mothers
- Known brain metastasis. History of or known spinal cord compression, or carcinomatous
meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT
or MRI scan
- Less than 5 years free of another primary malignancy except: if the other primary
malignancy is not currently clinically significant nor requiring active intervention,
or if other primary malignancy is a basal cell skin cancer or cervical carcinoma in
situ
- Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
- Ongoing cardiac dysrhythmias of grade 2 or greater, atrial fibrillation, QTc interval
>450msec for males of >470 msec for females
- Hypertension that cannot be controlled by medication
- Any of the following within 12 months prior to starting treatment: myocardial
infarction, severe/unstable angina, coronary/peripheral artery bypass graft,
congestive heart failure, cerebrovascular accident or transient ischemic attack, or
pulmonary embolism
- NCI CTCAE version 3.0 grade 3 hemorrhage within 4 weeks of starting the study
treatment
- Concurrent treatment with warfarin
- Prior treatment with SU011248 or any other antiangiogenic agent
- No H2 blockers or proton pump inhibitors
- Known chronic liver disease
- Known HIV infection
- Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy
within 4 weeks prior to study entry
- Major surgery within 4 weeks prior to study entry
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
the normal range with medication
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Descriptive Information | ||||
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Brief Title ICMJE | SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma | |||
Official Title ICMJE | A Phase II Study of SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma | |||
Brief Summary | The purpose of this study is to evaluate how effective Sunitinib works in treating acral lentiginous and mucosal melanoma which has spread beyond the local region. Suninitib is a protein-tyrosine kinase inhibitor and acts as a c-kit inhibitor drug. It is believed to work by blocking signals on certain cancer cells which allow the malignant cells to multiply and spread due to a change in the genetic make up of the cancer cell. | |||
Detailed Description | OBJECTIVES: Primary
Secondary
| |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: Sunitinib
Other Names:
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Study Arms ICMJE | Experimental: Sunitinib
Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year. Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year. Intervention: Drug: Sunitinib | |||
Publications * | Buchbinder EI, Sosman JA, Lawrence DP, McDermott DF, Ramaiya NH, Van den Abbeele AD, Linette GP, Giobbie-Hurder A, Hodi FS. Phase 2 study of sunitinib in patients with metastatic mucosal or acral melanoma. Cancer. 2015 Nov 15;121(22):4007-15. doi: 10.1002/cncr.29622. Epub 2015 Aug 11. | |||
* 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 | 52 | |||
Original Estimated Enrollment ICMJE | 50 | |||
Actual Study Completion Date ICMJE | August 2014 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00577382 | |||
Other Study ID Numbers ICMJE | 06-145 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | F. Stephen Hodi, MD, Dana-Farber Cancer Institute | |||
Study Sponsor ICMJE | Dana-Farber Cancer Institute | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | |||
Verification Date | June 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |