Safety and Tolerability of ASLAN001 in Combination With Cisplatin and 5-FU or Cisplatin and Capecitabine

NCT02648425 | Completed Phase 1 DMC

• 1 other identifier: ASLAN001-002
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Solid Tumor

Keywords

ASLAN001; Varlitinib

Outcome Measures

Primary Outcomes (2)

• 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.

  First 2 cycles

• Safety and Tolerability of ASALN001

  Safety and tolerability as evaluated with: Adverse events.

  Baseline to post-dose

Secondary Outcomes (6)

• Preliminary assessment of the efficacy

  Along the study duration

• Pharmacokinetics profile (AUC) of ASLAN001

  Along the study duration

• Pharmacokinetics profile (Cmax) of ASLAN001

  Along the study duration

• Pharmacokinetics profile (Cmin) of ASLAN001

  Along the study duration

• Pharmacokinetics profile (RacAUC0-6) of ASLAN001

  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.

Study Arms (2)

Regimen A / Amended Regimen A

EXPERIMENTAL

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

EXPERIMENTAL

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

Interventions

ASLAN001 DRUG

ASLAN001 400mg BID daily; ASLAN001 500mg BID daily; or ASLAN001 300mg BID daily

Also known as: ARRY-334543, Varlitinib

Regimen A / Amended Regimen A; Regimen B

cisplatin + capecitabine DRUG

Cisplatin 80 mg/m2 IV infusion and capecitabine 1,000 mg/m2 orally BID for 14 days every 3 weeks

Regimen B

cisplatin + 5-fluorouracil (or+ Leucovorin) DRUG

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.

Regimen A / Amended Regimen A

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients 20 years of age or older at the time written informed consent is obtained.
• 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.

You may not qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ and hematological function as evidenced by the following laboratory studies within 14 days prior to enrolment:
• Hematological function, as follows:
• Absolute neutrophil count ≥ 1.5 x 109/L.
• Platelet count ≥ 100 x 109/L.
• Hemoglobin ≥ 9 g/dL.
• Coagulation function, as follows:
• Partial thromboplastin time or activated partial thromboplastin time ≤ 1.5 x upper limit of normal (ULN) per institutional laboratory normal range.
• International normalized ratio ≤ 1.5.
• Renal function, as follows:
• Creatinine clearance ≥ 50 mL/min as calculated by Cockcroft-Gault formula.
• Hepatic function, as follows:
• Total bilirubin ≤ 1.5 x ULN.
• AST and ALT ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases are present).
• Patients with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy.

Sponsors & Collaborators

• ASLAN Pharmaceuticals: lead

Study Sites (3)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Interventions

ARRY-334543; Cisplatin; Capecitabine; Fluorouracil; Leucovorin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• ASLAN Pharma

  ASLAN Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2015
• First Posted: January 7, 2016
• Study Start: August 5, 2014
• Primary Completion: June 12, 2017
• Study Completion: September 15, 2017
• Last Updated: October 25, 2018

Record last verified: 2018-10

Locations

HK (1); TW (2)