ASLAN001 in Combination With Oxaliplatin and Capecitabine or Oxaliplatin and 5-FU With Leucovorin
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 18
Summary
- Conditions
- Solid Tumors
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
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 mFolf...
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.
Tracking Information
- NCT #
- NCT02435927
- Collaborators
- Aslan Pharmaceuticals
- National Medical Research Council (NMRC), Singapore
- Investigators
- Principal Investigator: Matthew CH Ng National Cancer Centre, Singapore
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