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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00674102 |
The safety, tolerability, efficacy and pharmacokinetics of ASA404 when administered in combination with paclitaxel and Carboplatin are assessed. ASA404 is administered intravenously every 21 days to Japanese patients with Non small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Non-Small Cell Lung Cancer |
Drug: ASA404 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Phase I Trial of Intravenous ASA404 Administered in Combination With Paclitaxel and Carboplatin in Japanese Patients With NSCLC |
Estimated Enrollment: | 12 |
Study Start Date: | April 2008 |
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Lab values within the range as defined below within 2 weeks of study registration (Note: without the use of growth factors or blood transfusions):
Aspartate transaminase (AST) and alanine transaminase (ALT)
≤ 2.5 x ULN
Exclusion criteria
Patients with any one of the following
Other protocol-defined inclusion/exclusion criteria may apply.
Contact: Novartis Pharma KK | +81-3-3498-6399 |
Japan | |
Recruiting | |
Tokyo, Japan | |
Recruiting | |
Osaka, Japan | |
Recruiting | |
Aichi, Japan | |
Recruiting | |
Shizuoka, Japan |
Study Chair: | Novartis | Novartis |
Study ID Numbers: | CASA404A1101 |
Study First Received: | May 5, 2008 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00674102 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Vascular disrupting agent Non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms |
Lung Diseases Carboplatin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |