NCT02435927

ASLAN001 in Combination With Oxaliplatin and Capecitabine or Oxaliplatin and 5-FU With Leucovorin

Phase I Study to Evaluate the Safety and Tolerability of ASLAN001 in Combination With Oxaliplatin and Capecitabine or Oxaliplatin and 5-FU With Leucovorin

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, open-label, dose escalation study of ASLAN001 given in combination with CAPOX or mFolfox6, in patients with metastatic solid tumours, whom are suitable to receive CAPOX or mFolfox6, or with tumours that have dysregulated EGFR or HER2 signaling.

Detailed description

The study will use standard 3+3 design to determine the MTD (maximum tolerated dose) of ASLAN001 in combination with fixed dose of Oxaliplatin/Capecitabine (CAPOX) or 5-FU/leucovorin (mFolfox6). MTD of ASLAN001 in combination with CAPOX will first be determined followed by the combination with mFolfox6. The recommended Phase II dose will be the highest dose of the combination therapy that is considered to be tolerated in 6 patients.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	ASLAN001+ CAPOX (Oxaliplatin, capecitabine)	ASLAN001 in combination with oxaliplatin and capecitabine
DRUG	ASLAN001 + mFolfox6 (5-FU, leucovorin)	ASLAN001 in combination with 5-FU and leucovorin

Timeline

• Start date: 2014-08-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2015-05-06
• Last updated: 2021-04-28

Locations

1 site across 1 country: Singapore