NCT01721148

A Phase I Multiple Ascending Dose Study of ASLAN002 in Subjects With Advanced or Metastatic Solid Tumours

A Phase I Multiple Ascending Dose Study of ASLAN002 (BMS 777607) in Subjects With Advanced or Metastatic Solid Tumours

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: ASLAN Pharmaceuticals · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There is a great need for new therapies for carcinomas that have progressed on or not responded to current therapy. There are no approved Met targeted agents in standard clinical use. In the population of subjects with advanced carcinomas that are unresponsive to standard of care, and based on the relatively safe, reversible and monitorable toxicity profile of ASLAN002 in non clinical studies, the potential for benefit from ASLAN002 outweighs the potential risks for toxicity. The purpose of this study is to identify the maximum tolerated dose of ASLAN002 in subjects with advanced or metastatic solid tumours, as well as to define the overall safety profile of ASLAN002.

Detailed description

The purpose of the study is * To identify the maximum tolerated dose (MTD) of ASLAN002 in subjects with advanced or metastatic solid tumours * To define the overall safety profile of ASLAN002 * To assess the effects of ASLAN002 on overall cardiac function as measured by blood pressure (BP), heart rate (HR), electrocardiogram (ECG) changes, and left ventricular function Secondary: * To characterize the pharmacokinetics (PK) of ASLAN002 and its N-oxide metabolite, following single and multiple dosing * To provide a preliminary assessment of anti-tumour activity, as assessed by the Overall Response Rate (ORR) and changes from baseline in tumour size

Conditions

• Malignant Solid Tumour

Interventions

Type	Name	Description
DRUG	ASLAN002( BMS 777607)	100mg, 200mg, 300mg, 450mg, 600mg

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2012-11-05
• Last updated: 2017-01-25