Phase 2
N=52
SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
Mucosal Lentiginous Melanoma · Acral Lentiginous Malignant Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00577382 ↗Enrolled (actual)
52
Serious AEs
44.2%
Results posted
Dec 2016
Primary outcome: Primary: 2-month Progression-free Survival Rate — .52; .52 proportion of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sunitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2-month Progression-free Survival Rate |
.52; .52 | — |
| SECONDARY Best Overall Response Rate |
0.095; 0.065 | — |
| SECONDARY Overall Survival |
7.7; 6.8 | — |
| SECONDARY Time to Progression |
2.7; 3.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00577382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.