LEAC-102 for Advanced Colorectal Cancer

NCT02826837 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: LEAC-102-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of LEAC-102 in Combination with FOLFOX + Bevacizumab/Cetuximab in Subjects with Advanced Colorectal Cancer

Conditions

Advanced Colorectal Cancer

Keywords

Advanced Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  First two cycles of FOLFOX + Bevacizumab/Cetuximab for advanced Colorectal Cancer (cycle length = 2 weeks)

  Week 4

Secondary Outcomes (12)

• Incidence of adverse events (AEs)

  Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24

• Incidence of serious adverse events (SAEs)

  Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24

• Response rate

  Week 24

• Progression free survival

  Week 24

• Overall survival

  Week 24

Study Arms (1)

LEAC-102 and FOLFOX+Bevacizumab/Cetuximab

EXPERIMENTAL

The subjects will be administered folinic acid (Leucovorin; LV), Fluorouracil (5-FU) and Oxaliplatin (FOLFOX) + Bevacizumab/Cetuximab by intravenous infusion. Cycles repeat every 2 weeks. Dose and schedule modifications may be made at the treating physician's discretion. A standard 3+3 trial design will be used for LEAC-102 dose escalation cohorts.The dosing of LEAC-102 will be divided into 3 cohorts, the subjects will receive LEAC-102 every day Cohort 1: LEAC-102 500 mg capsule, 3 capsules, three times per day for 24 weeks (oral), Cohort 2: LEAC-102 500 mg capsule, 4 capsules, three times per day for 24 weeks (oral), Cohort 3: LEAC-102 500 mg capsule, 5 capsules, three times per day for 24 weeks (oral)

Drug: LEAC-102 500mg capsule and FOLFOX + Bevacizumab/Cetuximab

Interventions

LEAC-102 500mg capsule and FOLFOX + Bevacizumab/Cetuximab DRUG

The subjects will be administered FOLFOX + Bevacizumab/Cetuximab by intravenous infusion. Cycles repeat every 2 weeks. Dose and schedule modifications may be made at the treating physician's discretion. A standard 3+3 trial design will be used for LEAC-102 dose escalation cohorts.The dosing of LEAC-102 will be divided into 3 cohorts, the subjects will receive LEAC-102 every day Cohort 1: LEAC-102 500 mg capsule, 3 capsules, three times per day for 24 weeks (oral), Cohort 2: LEAC-102 500 mg capsule, 4 capsules, three times per day for 24 weeks (oral), Cohort 3: LEAC-102 500 mg capsule, 5 capsules, three times per day for 24 weeks (oral)

LEAC-102 and FOLFOX+Bevacizumab/Cetuximab

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged at least 20 years old
• Histologically or cytologically confirmed measurable and/or evaluable advanced (stage III/IV) colorectal cancer that can be accurately assessed by CT/MRI scan (RECIST v1.1) for which regimen of FOLFOX + Bevacizumab/Cetuximab is arranged by the investigator
• Subjects may be treatment naïve, or may have received therapy for colorectal cancer.
• ECOG performance status ≤ 2 and life expectancy ≥ 12 months Note: ECOG = Eastern Cooperative Oncology Group
• Dated and signed informed consent

You may not qualify if:

• Primary CNS malignancies or clinically active CNS metastases Note: CNS = central nervous system
• Ascertained hypersensitivity to any component of investigational product or FOLFOX + Bevacizumab/Cetuximab that the subject will be treated
• Any of the following hematologic abnormalities:
• Hemoglobin \< 10.0 g/dL,
• ANC \< 1,500/μL,
• Platelets \< 100,000 /μL Note: ANC = absolute neutrophil count
• Any of the following serum chemistry abnormalities:
• Total bilirubin \> 1.5 × ULN,
• AST or ALT \> 2.5 × ULN,
• Gamma-GT \> 2.5 x ULN,
• Alk-P \> 2.5 x ULN,
• serum albumin \< 3.0 g/dL,
• creatinine \> 1.5 × ULN,
• any other ≥ Grade 3 laboratory abnormality at baseline (other than those listed above)
• Note: ULN = upper limit of normal. AST = aspartate transaminase, ALT: alanine transaminase, Gamma-GT = Gamma-glutamyl transferase, Alk-P = alkaline phosphatase

Sponsors & Collaborators

• Taiwan Leader Biotech Corp.: lead

MeSH Terms

Interventions

Bevacizumab; Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Cora Chen, Ph.D,

CONTACT

+886-978723555; cora_chen@twleaderlife.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: July 11, 2016
• Study Start: September 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: October 6, 2021

Record last verified: 2021-09