Clinical trial · Interventional
SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
A Phase II Study of SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
NCT00577382CI-TRIAL-00025084completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acral Lentiginous Malignant Melanoma | Acral Lentiginous Melanoma | ALIAS | 0.90 |
| Mucosal Lentiginous Melanoma | Mucosal Lentiginous Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sunitinib
- description
- 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.
- interventionNames
- Drug: Sunitinib
Primary outcomes (1)
- measure
- 2-month Progression-free Survival Rate
- timeFrame
- Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months.
- description
- 2-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 2 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTBuchbinder 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. PMID 26264378