Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT02435927
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2015-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ASLAN001 in Combination With Oxaliplatin and Capecitabine or Oxaliplatin and 5-FU With Leucovorin
Sponsor:
National Cancer Centre, Singapore
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: