An Open-label, Phase I Trial of Intravenous ASA404 Administered in Combination With Paclitaxel and Carboplatin in Japanese Patients With Non-Small Cell Lung Cancer (NSCLC)

Phase 1

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: ASA404

• Registration Number: NCT00674102
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-07
• Primary Completion: 2009-03
• Status Verified: 2016-04
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASA404	ASA404	-

Primary Outcome Measures

Name	Time	Method
To assess the safety profile and tolerability of ASA404 when administered in combination with paclitaxel and carboplatin in Japanese patients with non small cell lung cancer	First cycle

Secondary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetics profile of ASA404 in Japanese patients	every 2 cycles

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Tokyo, Japan