Clinical and pharmacokinetic phase II study of one hour infusion of kahalalide F administered every week to patients with Non Small Cell Lung Cancer Stage IIIB with pleural effusion and stage IV, after first line chemotherapy
Phase 1
- Conditions
- on Small Cell Lung Cancer Stage IIIB and IV after first Line ChemotherapyMedDRA version: 5.0Level: LLTClassification code 10029514
- Registration Number
- EUCTR2004-001253-29-ES
- Lead Sponsor
- PharmaMar SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
Histologically proven diagnosis of Non Small Cell Lung Cancer Stage IIIB with pleural effusion and Stage IV ,with progressive disease within the last four months
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
Previous Chemotherapy within the last four weeks
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluar la actividad antitumoral de Kahalalide administrado en infusion semanal de una hora a pacientes con cancer de pulmon no microcitico, estadio IIIB con derrame pleural y estado IV , tras una primera linea de quimioterapia.;Secondary Objective: Perfil de toxicidad, evaluacion farmacocinetica.;Primary end point(s): Objective Response (Complete Response and Partial Response)
- Secondary Outcome Measures
Name Time Method