A Phase 1 interventional study of ASLAN001 and cisplatin + capecitabine in Solid Tumor, sponsored by ASLAN Pharmaceuticals. Completed at 3 sites in 2 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-10-25.
Sponsored by ASLAN Pharmaceuticals · Phase 1, Interventional, and Treatment
This is a phase IB study to assess the safety and tolerability of ASLAN001 when given in combination with either Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine, with a view to identifying the recommended Phase II dose.
This is an open-label, Phase I, dose escalation study of ASLAN001 given in combination with Regimen A or Regimen B, in patients with metastatic solid tumors, eligible to receive the cisplatin/5-fluorouracil or cisplatin/capecitabine regimen.
Dose of ASLAN001 starts from 400mg BID; then, dose escalation to 500mg BID or dose de-escalation to 300mg BID will depend on DLTs observed in cohort.
Regimen A: Depends on preferred medical practice, Cohort 1A will receive ASLAN001 400 mg BID in combination with cisplatin 80 mg/m2 IV infusion and 5 fluorouracil 800 mg/m2/day IV infusion for 5 days every 3 weeks; or will receive ASLAN001 400 mg BID in combination with Cisplatin 35 mg/m2 24-hour infusion for day 1 and day 8, 5-fluorouracil 2,000 mg/m2 and Leucovorin 300mg/m2 24-hour infusion for day 1, day 8 and day 15 every 4 weeks.
Regimen B: Cohort 1B will receive ASLAN001 400 mg BID in combination with cisplatin 80 mg/m2 IV infusion and oral capecitabine 1,000 mg/m2 BID for 14 days every 3 weeks.
ASLAN Pharmaceuticals is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Regimen A: Patients with metastatic solid tumors eligible for treatment with cisplatin and 5-fluorouracil. The standard dose and schedule of cisplatin and 5-fluorouracil will be according to the preference of investigators and institutions.
Regimen B: Patients with metastatic solid tumors eligible for treatment with cisplatin in combination with capecitabine.
Hematological function, as follows:
Coagulation function, as follows:
Renal function, as follows:
Hepatic function, as follows:
Exclusion Criteria:
Regimen A: Cisplatin + 5-fluorouracil ASLAN001 daily in combination with: Cisplatin 80 mg/m2 IV infusion for 1 day and 5-fluorouracil 800 mg/m2/day IV infusion for 5 days every 3 weeks for up to 6 cycles. Or Amended Regimen A: Cisplatin + 5-fluorouracil + leucovorin ASLAN001 daily in combination with: Cisplatin 35 mg/m2 24-hour infusion for day 1 and day 8, 5-fluorouracil 2,000 mg/m2 and Leucovorin 300mg/m2 24-hour infusion for day 1, day 8 and day 15 every 4 weeks for up to 6 cycles.
Drug: ASLAN001 · Drug: cisplatin + 5-fluorouracil (or+ Leucovorin)
Regimen B: Cisplatin + capecitabine ASLAN001 daily in combination with: Cisplatin 60-80 mg/m2 IV infusion on Day 1 and capecitabine 1,000 mg/m2 orally BID for 14 days every 3 weeks for up to 6 cycles.
Drug: ASLAN001 · Drug: cisplatin + capecitabine
ASLAN001 400mg BID daily; ASLAN001 500mg BID daily; or ASLAN001 300mg BID daily
Also known as: ARRY-334543, Varlitinib
Cisplatin 80 mg/m2 IV infusion and capecitabine 1,000 mg/m2 orally BID for 14 days every 3 weeks
Cisplatin 80 mg/m2 IV infusion and 5-fluorouracil 800 mg/m2/day IV infusion for 5 days every 3 weeks; Or Cisplatin 35 mg/m2 24-hour infusion for day 1 and day 8, 5-fluorouracil 2,000 mg/m2 and Leucovorin 300mg/m2 24-hour infusion for day 1, day 8 and day 15 every 4 weeks.
Safety and Tolerability of ASALN001
Safety and tolerability as evaluated with: DLTs (in first 2 cycles); Maximum tolerated dose (MTD) of ASLAN001 in combination with cisplatin/capecitabine or cisplatin/5-FU will be determined.
Time frame: First 2 cycles
Safety and Tolerability of ASALN001
Safety and tolerability as evaluated with: Adverse events.
Time frame: Baseline to post-dose
Preliminary assessment of the efficacy
•To provide a preliminary assessment of the efficacy of ASLAN001 when given in combination in Regimen A or Regimen B as measured by the objective response rate (ORR).
Time frame: Along the study duration
Pharmacokinetics profile (AUC) of ASLAN001
To evaluate the pharmacokinetics of ASLAN001, when given in combination with Regimen A or Regimen B. Pharmacokinetic parameters including, but not limited to area under the plasma concentration-time curve (AUC) from 0 to 6 hours (AUC0-6).
Time frame: Along the study duration
Pharmacokinetics profile (Cmax) of ASLAN001
To evaluate the pharmacokinetics of ASLAN001, when given in combination with Regimen A or Regimen B. Pharmacokinetic parameters including, but not limited to maximum plasma concentration (Cmax).
Time frame: Along the study duration
Pharmacokinetics profile (Cmin) of ASLAN001
To evaluate the pharmacokinetics of ASLAN001, when given in combination with Regimen A or Regimen B. Pharmacokinetic parameters including, but not limited to minimum (trough) plasma concentration (Cmin).
Time frame: Along the study duration
Pharmacokinetics profile (RacAUC0-6) of ASLAN001
To evaluate the pharmacokinetics of ASLAN001, when given in combination with Regimen A or Regimen B. Pharmacokinetic parameters including, but not limited to accumulation ratio for AUC (RacAUC0-6).
Time frame: Pharmacokinetic measurements will be from Cycle 1 Day 1 to Cycle 3 Day 1 (each cycle is 28 days for Amended Regimen A, and 21 days for Regimen A and B.
Pharmacokinetics profile (Tmax) of ASLAN001
To evaluate the pharmacokinetics of ASLAN001, when given in combination with
Time frame: Along the study duration
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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ASLAN Pharmaceuticals