Clinical trial · Interventional
Vatalanib in Treating Patients With Metastatic Cutaneous Melanoma That Cannot be Removed by Surgery
A Phase II Study to Evaluate the Efficacy and Safety of PTK787 in Patients With Metastatic Cutaneous Melanoma
NCT00563823CI-TRIAL-00011540completedPhase 2ClinicalTrials.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)
RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with metastatic cutaneous melanoma that cannot be removed by surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vatalanib | Drug | Vatalanib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate as assessed by RECIST every 8 weeks
Secondary outcomes (4)
- measure
- Time to progression
- measure
- Survival at 6 months and 1 year
- measure
- Overall survival
- measure
- Toxicity as assessed by NCI CTCAE v3.0 at 2 weeks and then every 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic cutaneous melanoma * Unresectable disease * Measurable disease, defined as ≥ 1 bidimensionally measurable lesion by clinical or radiological techniques (i.e., chest x-ray, CT scan, or conventional MRI scan) using RECIST criteria * No history or presence of CNS disease (i.e., primary brain tumor, malignant seizures, clinically symptomatic CNS metastases, or carcinomatous meningitis) PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * Hemoglobin ≥ 10 g/dL * Platelet count ≥ 100,000/mm\^3 * WBC ≥ 3,000/mm\^3 * ANC ≥ 1,500/mm\^3 * Bilirubin ≤ 1.5 x upper limit of normal (ULN) * Alkaline phosphatase ≤ 3 x ULN (≤ 5 if liver metastases are present) * Transaminases ≤ 3 x ULN (≤ 5 if liver metastases are present) * Creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min * Total urinary protein ≤ 500 mg by 24-hour urine collection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * No history of other malignant disease except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No other serious or uncontrolled illness which, in the opinion of the investigator, precludes study entry * No medical or psychiatric condition that precludes giving informed consent * No history of renal disease (e.g., glomerulonephritis) or renal vascular disease * No acute or chronic active liver disease (e.g., hepatitis or cirrhosis) * No concurrent severe and/or uncontrolled medical conditions that would compromise participation in the study, including any of the following: * Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen * Unstable angina pectoris * Symptomatic congestive heart failure * Myocardial infarction within the past 6 months * Serious uncontrolled cardiac arrhythmia * Uncontrolled diabetes * Active or uncontrolled infection * No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib including, but not limited to, any of the following conditions: * Ulcerative disease * Uncontrolled nausea * Vomiting * Diarrhea which might result in malabsorption * Any known malabsorption syndrome * Bowel obstruction * Inability to swallow the capsules/tablets PRIOR CONCURRENT THERAPY: * Recovered from all prior therapy * Prior adjuvant therapy allowed * Prior radiotherapy allowed * Measurable target lesions must not have been irradiated * No more than one line of prior systemic therapy for advanced melanoma * More than 4 weeks since prior chemotherapy, immunotherapy, or investigational agent * More than 2 weeks since prior surgery * No concurrent warfarin or other similar oral anticoagulants that are metabolized by the cytochrome p450 system * Concurrent heparin allowed * Concurrent radiotherapy for symptomatic disease is allowed, provided the lesions being irradiated contribute ≤ 20% of the sum of the longest diameter for all target lesions being used to determine response
References
Publications (1)
- RESULTCook N, Basu B, Biswas S, Kareclas P, Mann C, Palmer C, Thomas A, Nicholson S, Morgan B, Lomas D, Sirohi B, Mander AP, Middleton M, Corrie PG. A phase 2 study of vatalanib in metastatic melanoma patients. Eur J Cancer. 2010 Oct;46(15):2671-3. doi: 10.1016/j.ejca.2010.07.014. Epub 2010 Aug 25. PMID 20800475