non-resectable metastatic malignant melanoma
Conditions
Interventions
Product Name: PTK787/ZK222584
Product Code: PTK/ZK
Pharmaceutical Form: Tablet
Current Sponsor code: PTK787/ZK 222584
Other descriptive name: (4-chlorophenyl)[4-(4-pyridylmethyl)phthalazin-1-yl]ammoni
Sponsors
Univeristy Hospital Schleswig-Holstein
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed nonresectable metastatic melanoma Stage III or IV (AJCC 2002) including patients with unknown primary melanoma, 2) Progressive disease, defined as an increase of tumour volume according to RECIST criteria, within the last 6 months, 3) Fulfilling the minimum RECIST requirements for evaluation of tumor response, 4) At least two cutaneous or soft tissue lesions that can be biopsized prior to and after treatment, respectively, 5) Able to undergo either contrast-enhanced CT scan or contrast-enhanced MRI scan for tumor assessment, 6) Life expectancy greater than 3 months, 7) ECOG performance status 18 years, 9) Able to swallow and retain intact investigational drug tablets, 10) Willingness and ability to adhere to the study requirements as outlined in the protocol, 11) Agreement to use a highly effective method of birth control throughout the study period and 3 months thereafter for sexually active males and females of childbearing potential. Barrier contraceptives must be used throughout the trial. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. 12) Able to provide informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) One or more previous systemic therapies for metastatic melanoma, excluding prior systemic therapy given for high-risk primary tumor, lymph node metastasis, or other regional (AJCC stage III) disease spread as postoperative adjuvant therapy. 2) Anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy, and hormone therapy) delivered within 4 weeks prior to the 1st dose of study drug, and 2 weeks prior for palliative “spot” radiotherapy to bone metastases), 3) History of uveal melanoma, 4) Female patients who are pregnant or breast feeding. Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to administration of study treatment. 5) Impaired organ and bone marrow function defined as one or more of the following: - Absolute neutrophil count (ANC) 1.5 x ULN, - ASAT (SGOT)/ALAT (SGPT) > 3x ULN (5x if liver metastases are present) 6) History or presence of central nervous system (CNS) disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis) 7) Another malignancy in the 5 years prior to enrollment other than non melanoma skin cancer, or cervix carcinoma in situ, 8) Major Surgery 1.5* upper limit of normal (ULN) OR - Proteinuria based on dip stick reading positive > +1 OR - if the dip stick result is +1, total urinary protein > 500 mg and measured creatinine clearance 9 g/dL) 19) Other uncontrolled concomitant condition, including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, uncontrolled diabetes, seizure disorder 20) Psychiatric illness/social situations that would limit compliance with study requirements, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study 21) Human immunodeficiency virus (HIV) infection, 22) Prior enrollment into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of PTK-ZK on metastatic melanoma either as a single agent treatment or in combination with standard chemotherapy according to RECIST criteria. Further to evaluate the safety and tolerability of PTK-ZK in patients with metastatic melanoma either as a single agent treatment or in combination with standard chemotherapy;Secondary Objective: A side study shall evaluate anti-angiogenic and anti-lymphangiogenic effects of PTK-ZK and possible markers for treatment response in blood and tissue specimens;Primary end point(s): Overall response defined by RECIST criteria | — |
Countries
Germany
Outcome results
None listed