unresectable advanced melanoma MedDRA version: 5.0 Level: LLT Classification code 10027150
Conditions
Interventions
Product Name: plitidepsin (Aplidin)
Product Code: APL
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Plitidepsin
Sponsors
Pharma Mar SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 within 14 days prior to first infusion: ·Aspartate aminotransferase (AST) = 2.5 x ULN ·Alanine aminotransferase (ALT) = 2.5 x ULN 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
Exclusion criteria
Exclusion criteria: 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: . History or presence of unstable angina, myocardial infarction, valvular heart disease or congestive heart failure ·Previous mediastinal radiotherapy ·Uncontrolled arterial hypertension despite optimal therapy ·Any grade of Cardiac arrhythmia according to CTCAE v3.0 (see Appendix 6) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 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 · Dose limiting toxicities | — |
Countries
Spain, United Kingdom
Outcome results
None listed