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Report for Clinical Trial NCT02435927

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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


1 T790M

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