ASLAN001 in Combination With Oxaliplatin and Capecitabine or Oxaliplatin and 5-FU With Leucovorin

NCT02435927 | Unknown Phase 1

• 1 other identifier: ASLAN001-002SG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of ASLAN001 when used in combination with Oxaliplatin and Capecitabine (CAPOX) or Oxaliplatin and 5-FU with leucovorin (mFolfox6)

  one year

Secondary Outcomes (4)

• Pharmacokinetic parameter Area under the plasma concentration time curve (AUC)

  Day 1 and Day 15 of Cycle 1 and Day 1 of Cycle 3

• Pharmacokinetic parameter Maximum plasma concentration (Cmax)

  Day 1 and Day 15 of Cycle 1 and Day 1 of Cycle 3

• Pharmacokinetic parameter Minimum (trough) plasma concentration (Cmin)

  Day 1 and Day 15 of Cycle 1 and Day 1 of Cycle 3

• Efficacy of ASLAN001 when given in combination in CAPOX or mFolfox6 as measured by the objective response rate (ORR)

  one year

Study Arms (2)

ASLAN001 + CAPOX

EXPERIMENTAL

ASLAN001 + CAPOX: ASLAN001 twice daily in combination with oxaliplatin 130 mg/m2 intravenously on day 1 and capecitabine 850 mg/m2 orally twice daily on days 1 to 14 every 3 weeks

Drug: ASLAN001+ CAPOX (Oxaliplatin, capecitabine)

ASLAN001 + mFolfox6

EXPERIMENTAL

ASLAN001 + mFolfox6: ASLAN001 twice daily in combination with mFolfox6 (oxaliplatin 85 mg/m2 intravenously on day 1 and 5-FU bolus 400mg/m2 i.v on day 1 and as a continuous infusion 2400mg/ m2 over 46h and leucovorin 400mg/2 i.v on day 1) every 2 weeks

Drug: ASLAN001 + mFolfox6 (5-FU, leucovorin)

Interventions

ASLAN001+ CAPOX (Oxaliplatin, capecitabine) DRUG

ASLAN001 in combination with oxaliplatin and capecitabine

Also known as: eloxatin, xeloda

ASLAN001 + CAPOX

ASLAN001 + mFolfox6 (5-FU, leucovorin) DRUG

ASLAN001 in combination with 5-FU and leucovorin

Also known as: 5-Fluorouracil, Folinic acid

ASLAN001 + mFolfox6

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with metastatic solid tumours eligible for treatment with oxaliplatin in combination with capecitabine / 5-FU (fluorouracil) and leucovorin or who progressed following standard therapy or patients with EGFR (epidermal growth factor receptor ) or HER2 dysregulated tumours.

You may not qualify if:

• Eastern Cooperative Oncology Group 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: Prothrombin time and activated partial thromboplastin time ≤ 1.5 x upper limit of normal (ULN) per institutional laboratory normal range.
• 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. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases are present).
• 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.
• Co-expression of HER2 and EGFR
• Archival tumour sample is available for molecular profiling, unless undergoing tumour biopsy as part of the trial.
• Patients with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy.
• Patients receiving proton pump inhibitors or H2 antagonists for established, symptomatic gastro duodenal ulceration or gastroesophageal reflux disease. H2 antagonist can be prescribed after DLT (dose-limiting toxicity) period (the first 2 cycles) at the discretion of the investigator.
• Patients with unresolved toxicities of grade 2 or more from prior anti-cancer therapies excluding alopecia.
• Untreated or symptomatic central nervous system metastases. Patients with treated brain metastases stable for 3 months are eligible to enroll.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• ASLAN Pharmaceuticals: collaborator
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

National Cancer Centre

Singapore, 169610, Singapore

Location

MeSH Terms

Interventions

Oxaliplatin; Capecitabine; Fluorouracil; Leucovorin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; 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

• Matthew CH Ng

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

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: April 23, 2015
• First Posted: May 6, 2015
• Study Start: August 1, 2014
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

SG (1)