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
EudraCT/CTIS number	2005-004710-33
ClinicalTrials.gov number	NCT00563823
Secondary identifying numbers	CAMEL 02

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

Oncology Centre
Box 193
Cambridge University Hospitals NHS Foundation Trust
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)1223 216083
Email	pippa.corrie@addenbrookes.nhs.uk

Study information

Study design	Interventional, open-label, uncontrolled, phase II study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	PTK787/ZK222584
Primary outcome measure	Objective response rate
Secondary outcome measures	1. Time to progression 2. Survival at six months and one year 3. Overall survival 4. Safety and toxicity 5. Correlation of pharmacological and genetic markers to response 6. Correlation of tumour vascularity and permeability to response
Overall study start date	03/01/2006
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Oncology Centre

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Trust Research and Development Department
Box 146
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
England
United Kingdom

"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Hospital/treatment centre

Addenbrookes Charities Research Advisory Committee

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Results article	results	01/10/2010		Yes	No

Editorial Notes

19/03/2020: EudraCT number added. Added EudraCT link to basic results (scientific).