Phase I-II multicenter, randomized, open-label, clinical and pharmacokinetic study of plitidepsin, administered alone or in combination with dacarbazine, as front-line therapy to subjects with unresectable advanced melanoma
- Conditions
- unresectable advanced melanomaMedDRA version: 5.0Level: LLTClassification code 10027150
- Registration Number
- EUCTR2005-001161-34-ES
- Lead Sponsor
- Pharma Mar SA, sociedad unipersonal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1.Voluntary written informed consent
2.Malignant melanoma histologically proven
3.Advanced melanoma
4.Age from 18 years
5. measurable disease
6.Recovery from any non-hematologic drug-related adverse event derived from previous treatment
7.Laboratory values
8.Performance status
9.Life expectancy > 3 months
10.Left ventricular ejection fraction (LVEF) within normal limits
11. negative serum pregnancy and Acceptable methods of contraception
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
1. prior systemic therapy for the treatment of metastatic melanoma
2.Subjects relapsing / progressing within 6 months after the end of adjuvant or neo-adjuvant systemic drug therapy for non-metastatic melanoma
3. loco-regional melanoma previously treated with loco-regional drug therapy with disease relapse or progression within the treated area
4.Subjects for whom surgery would be expected to result in cure or significant palliation
5.Less than 4 weeks from radiation therapy
6.Evidence of progressive CNS metastases or any symptomatic brain or leptomeningeal metastases
7.Other relevant diseases or adverse clinical conditions
8.Pregnant or lactating women
9.Limitation of the patient’s ability to comply with the treatment or follow-up procedures and visits defined in the study protocol
10.Known hypersensitivity to any component of the study drug products, including plitidepsin, dacarbazine, cremophor, mannitol, citrate, or ethanol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the efficacy of plitidepsin, alone or in combination with dacarbazine, in the front-line treatment of subjects with unresectable advanced melanoma<br><br>To determine the MTD and RD of plitidepsin administered in combination with dacarbazine to patients with advanced unresectable melanoma;Secondary Objective: To further study the pharmacokinetics of plitidepsin, including drug-drug pharmacokinetic interactions between plitidepsin and dacarbazine<br><br>To evaluate the safety and tolerability of plitidepsin, administered alone or in combination with dacarbazine, as front-line therapy of subjects with unresectable advanced melanoma;Primary end point(s): ·Efficacy<br>·Dose limiting toxicities
- Secondary Outcome Measures
Name Time Method