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A Phase II Study to Evaluate the Efficacy and Safety of PTK787 in Patients With Metastatic Cutaneous Melanoma

Phase 2
18 Years
Open (Enrolling)
Cutaneous Melanoma

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Trial Information

A Phase II Study to Evaluate the Efficacy and Safety of PTK787 in Patients With Metastatic Cutaneous Melanoma



- To determine the response rate in patients with unresectable metastatic cutaneous
melanoma treated with vatalanib.


- To determine the time to progression in these patients.

- To determine the 6-month and 1-year survival of these patients.

- To determine the overall survival of these patients.

- To determine the safety and toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral vatalanib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed at 8 weeks and then periodically

Inclusion Criteria


- 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)


- 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

- Ulcerative disease

- Uncontrolled nausea

- Vomiting

- Diarrhea which might result in malabsorption

- Any known malabsorption syndrome

- Bowel obstruction

- Inability to swallow the capsules/tablets


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate as assessed by RECIST every 8 weeks

Safety Issue:


Principal Investigator

Pippa Corrie, PhD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

Cambridge University Hospitals NHS Foundation Trust


United States: Federal Government

Study ID:




Start Date:

February 2006

Completion Date:

Related Keywords:

  • Cutaneous Melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma
  • Skin Neoplasms