Clinical Study of Previously Untreated Patients With Malignant Melanoma

Sponsor

Clavis Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00232726

Collaborator

(none)

Enrollment

Locations

21.9

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Previously untreated patients with malignant melanoma receive a new chemotherapy drug currently under development. CP-4055 is given intravenously on days 1-5 every four weeks until complete response or disease progression.

Condition or Disease	Intervention/Treatment	Phase
Malignant Melanoma Neoplasm Metastasis	Drug: CP-4055 (ELACYT)	Phase 2

Detailed Description

This is an international multicentre phase II clinical study conducted in the USA and Europe. Previously untreated patients over 18 years, with metastatic malignant melanoma are eligible for inclusion if they fulfil all inclusion- and exclusion criteria. 16 or 42 patients will be enrolled in Pittsburgh USA, Lund Sweden and Oslo Norway.

The new development drug CP-4055 is administered for five consecutive days (Day 1 to 5) in a 4 week schedule (one cycle). The dose is 200 mg/m2/day.

A patient will continue treatment until complete response or until (s)he is withdrawn from the Clinical Study because of disease progression, unacceptable toxicity or any other reason described in the clinical study protocol.

Efficacy is assessed at baseline and end of every second cycle with CT or MRI.

Safety assessments are done at each visit. Blood samples are taken and haematological and biochemical parameters are assessed for safety.

Any adverse events are recorded and reported.

The clinical study has been approved by the relevant Independent Ethical Committees/Institutional Review Boards and Concerned Regulatory Authority as appropriate. It is conducted according to ICH Good Clinical Practice, the Declaration of Helsinki, and applicable national law and regulations.

Patients who give an additional consent will have two additional, and not mandatory, procedures performed:

Biopsy (tissue sample) from particular tumours (taken only at baseline for identification of tumour genes)
Serum samples (from blood drawn at baseline and at end of the cycle 2 for protein sequences analyses, proteomics)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Non-Randomised, Multicentre, Phase II Clinical Study of CP-4055 in Chemotherapy-Naïve Patients With Metastatic Malignant Melanoma

Study Start Date :

Sep 1, 2005

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

Objective tumour response []

Secondary Outcome Measures

Time to progression []
Duration of tumour response []
Safety and tolerability of treatment []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with histologically or cytologically confirmed stage IV or unresectable stage III non-ocular malignant melanoma who have not undergone prior chemotherapy for the treatment of melanoma (chemotherapy-naïve)
Measurable disease according to Response Criteria in Solid Tumours (RECIST)
Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
Age 18 years or more
Life expectancy > 3 months
Signed informed consent
Adequate haematological and biological functions:
Bone marrow function:

Neutrophils ≥ 1.5 x 10^9/L
Platelets ≥ 100 x 10^9/L
Hemoglobin (Hb) ≥ 10 g/dL

Hepatic function:

AST/ALT ≤ 2.5 times institutional upper limit of normal (ULN). If liver metastases, ≤ 5 times institutional ULN.
Serum bilirubin and alkaline phosphatase ≤ 1.5 times institutional ULN

Renal function:
Creatinine ≤ 1.5 times institutional ULN

Exclusion Criteria:

Known brain metastases
Diagnosis of ocular malignant melanoma
Radiotherapy to more than 30% of bone marrow
Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
Prior immunotherapy and/or chemotherapy for the treatment of melanoma
Requirement of concomitant treatment with a non-permitted medication:
Alternative drugs
High doses of vitamins
History of allergic reactions to Ara-C or egg
Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled intercurrent illness including ongoing or active infection)
Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
Pregnancy, breastfeeding, or absence of adequate contraception for both male and female fertile patients
Known positive status for HIV and/or hepatitis B or C
Drug and/or alcohol abuse
Any reason why, in the Investigator's opinion, the patient should not participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213-2584
2	The Norwegian Radium Hospital	Oslo		Norway	NO-0310
3	University Hospital	Lund		Sweden	SE-221 85