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Report for Clinical Trial NCT02435927
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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.
NCT02435927 Solid Tumors
2 Interventions
Name: ASLAN001+ CAPOX (Oxaliplatin, capecitabine)
Description: ASLAN001 in combination with oxaliplatin and capecitabine
Type: Drug
Group Labels: 1 ASLAN001 + CAPOX
Name: ASLAN001 + mFolfox6 (5-FU, leucovorin)
Description: ASLAN001 in combination with 5-FU and leucovorin
Type: Drug
Group Labels: 1 ASLAN001 + mFolfox6
Primary Outcomes
Measure: Maximum tolerated dose (MTD) of ASLAN001 when used in combination with Oxaliplatin and Capecitabine (CAPOX) or Oxaliplatin and 5-FU with leucovorin (mFolfox6) Time: one year
Secondary Outcomes
Measure: Pharmacokinetic parameter Area under the plasma concentration time curve (AUC) Time: Day 1 and Day 15 of Cycle 1 and Day 1 of Cycle 3
Measure: Pharmacokinetic parameter Maximum plasma concentration (Cmax) Time: Day 1 and Day 15 of Cycle 1 and Day 1 of Cycle 3
Measure: Pharmacokinetic parameter Minimum (trough) plasma concentration (Cmin) Time: Day 1 and Day 15 of Cycle 1 and Day 1 of Cycle 3
Measure: Efficacy of ASLAN001 when given in combination in CAPOX or mFolfox6 as measured by the objective response rate (ORR) Time: one year
Purpose: Treatment
Allocation: Non-Randomized
Parallel Assignment
There is one SNP
SNPs
5. Patients undergoing mandatory biopsy in dose expansion of a non-DLT cohort should have
any of the following:
- known HER2 or EGFR dysregulation
- Patients with T790M mutation will be excluded. --- T790M ---
HPO Nodes