Clinical trial · Interventional
Clinical Study of Previously Untreated Patients With Malignant Melanoma
A Non-Randomised, Multicentre, Phase II Clinical Study of CP-4055 in Chemotherapy-Naïve Patients With Metastatic Malignant Melanoma
NCT00232726CI-TRIAL-00000788completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CP-4055 (ELACYT) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective tumour response
Secondary outcomes (3)
- measure
- Time to progression
- measure
- Duration of tumour response
- measure
- Safety and tolerability of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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:
1. Neutrophils ≥ 1.5 x 10\^9/L
2. Platelets ≥ 100 x 10\^9/L
3. Hemoglobin (Hb) ≥ 10 g/dL
* Hepatic function:
1. AST/ALT ≤ 2.5 times institutional upper limit of normal (ULN). If liver metastases, ≤ 5 times institutional ULN.
2. 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 participateReferences
Publications (0)
Data not yet available
No reference posted for this study.