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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 April 2022 |
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Main ID: |
EUCTR2004-001253-29-ES |
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Date of registration:
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16/09/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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13/05/2004 |
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Target sample size:
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34 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001253-29 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled:
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV):
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Countries of recruitment
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Spain
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Non Small Cell Lung Cancer Stage IIIB and IV after first Line Chemotherapy
MedDRA version: 5.0
Level: LLT
Classification code 10029514
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Intervention(s)
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Product Name: kahalalide
Pharmaceutical Form: Powder and solvent for solution for infusion
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
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Primary Outcome(s)
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Primary end point(s): Objective Response (Complete Response and Partial Response)
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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.
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Secondary Objective: Perfil de toxicidad, evaluacion farmacocinetica.
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Secondary ID(s)
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KF-B-005-04
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 07/05/2004
Contact:
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