A Phase II study to evaluate the efficacy and safety of PTK787 in patients with metastatic cutaneous melanoma
| ISRCTN | ISRCTN00191981 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00191981 |
| ClinicalTrials.gov (NCT) | NCT00563823 |
| Clinical Trials Information System (CTIS) | 2005-004710-33 |
| Protocol serial number | CAMEL 02 |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust (UK) |
| Funder | Addenbrookes Charities Research Advisory Committee |
- Submission date
- 15/02/2006
- Registration date
- 04/04/2006
- Last edited
- 19/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Pippa Corrie
Scientific
Scientific
Oncology Centre
Box 193
Cambridge University Hospitals NHS Foundation Trust
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 216083 |
|---|---|
| pippa.corrie@addenbrookes.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional, open-label, uncontrolled, phase II study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A Phase II study to evaluate the efficacy and safety of PTK787 in patients with metastatic cutaneous melanoma |
| Study acronym | PTK787 |
| Study objectives | To determine the efficacy of PTK787 in patients with metastatic cutaneous melanoma in terms of objective response rate |
| Ethics approval(s) | Approved by the South East Medical Research Ethics Committee on 13/02/2006, reference number 06/MRE01/10 |
| Health condition(s) or problem(s) studied | Metastatic cutaneous melanoma |
| Intervention | Prior to commencing treatment with PTK787/ZK222584, patients will undergo the following interventions: 1. Dynamic contrast enhanced magnetic resonance imaging (MRI) scan of liver metastases 2. Tumour and adjacent tissue biopsy 3. Blood sample to measure soluble markers |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | PTK787/ZK222584 |
| Primary outcome measure(s) |
Objective response rate |
| Key secondary outcome measure(s) |
1. Time to progression |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 34 |
| Key inclusion criteria | 1. Life expectancy >12 weeks 2. Performance status 0, 1 or 2 (Eastern Cooperative Oncology Group [ECOG] performance scale) 3. Presence of one or more bi-dimensionally measurable lesions, either clinically or radiologically (by chest x-ray, computerised tomography [CT] or conventional magnetic resonance imaging [MRI] scan as appropriate) using response evaluation criteria in solid tumors (RECIST) criteria 4. Age >18 years 5. Hb >10 g/dl, platelets >100,000 mm^3, white cell count (WCC) >3.0 x 10^9 /l, absolute neutrophil count (ANC) >1.5 x 10^9 /l 6. Bilirubin <1.5 x upper limit of normal (ULN), alkaline phosphatase <3 x ULN, transaminases <3 x ULN, (or alkaline phosphatase and transaminases <5 if liver metastases are present) 7. Creatinine <1.5 x ULN 8. Measured creatinine clearance >50 ml/min and total urinary protein <500 mg per 24 hours 9. Written informed consent provided by the patient 10. Patients of both genders with reproductive potential not employing an effective method of birth control, 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. 11. Prior adjuvant therapy is allowed, as long as it was completed at least six months previously 12. One line of prior chemotherapy for advanced disease is allowed, as long as the best response to this treatment was complete response, partial response or stable disease, determined after a minimum of two cycles of planned treatment, using RECIST criteria 13. Prior radiotherapy is allowed, however measurable target lesions must not have been irradiated 14. Patients must not have a history of other malignant disease other than adequately treated non-melanomatous skin cancer or in situ carcinoma of the cervix |
| Key exclusion criteria | 1. Patients who have received a first line therapy for advanced disease, when the initial response was documented to be disease progression, using RECIST criteria 2. Any previous chemotherapy, immunotherapy or investigational agent within the last four weeks 3. Any other serious or uncontrolled illness, which in the opinion of the investigator makes it undesirable for the patient to enter the trial 4. Any medical or psychiatric condition, which would influence the ability to provide informed consent 5. Patients with a history of renal (e.g. glomerulonephritis) or renal vascular disease 6. Acute or chronic active liver disease (e.g. hepatitis, cirrhosis) 7. Surgery within two weeks of entry into the trial 8. Incomplete recovery from previous surgery or non-surgical treatment 9. History or presence of central nervous system (CNS) disease i.e. primary brain tumour, malignant seizures, clinically symptomatic CNS metastases or carcinomatous meningitis 10. Any of the following concurrent severe and/or uncontrolled medical conditions, which could compromise participation in the trial: a. Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen b. Unstable angina pectoris c. Symptomatic congestive heart failure d. Myocardial infarction under six months prior to randomisation e. Serious uncontrolled cardiac arrhythmia f. Uncontrolled diabetes g. Active or uncontrolled infection h. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK222584 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhoea which might result in malabsorption, any known malabsorption syndrome, bowel obstruction, or inability to swallow the capsules/tablets) 11. Patients who are taking warfarin or other similar oral anticoagulants that are metabolised by the cytochrome P450 system, heparin is acceptable 12. Pregnant or lactating women 13. Women of childbearing potential must have a negative serum pregnancy test with 48 hours of trial entry |
| Date of first enrolment | 03/01/2006 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Oncology Centre
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2010 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/03/2020: EudraCT number added. Added EudraCT link to basic results (scientific).
