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 - Not available

Phase 1

• Conditions: unresectable advanced melanoma; MedDRA version: 5.0 Level: LLT Classification code 10027150

• Registration Number: EUCTR2005-001161-34-GB
• Lead Sponsor: Pharma Mar SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-13
• Study Completion: 2010-10-19
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified