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LEAC-102 for Advanced Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02826837
Recruitment Status : Not yet recruiting
First Posted : July 11, 2016
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Taiwan Leader Biotech Corp.

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

Condition or disease Intervention/treatment Phase
Advanced Colorectal Cancer Drug: LEAC-102 500mg capsule and FOLFOX + Bevacizumab/Cetuximab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LEAC-102 and FOLFOX+Bevacizumab/Cetuximab

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

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)





Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: Week 4 ]
    First two cycles of FOLFOX + Bevacizumab/Cetuximab for advanced Colorectal Cancer (cycle length = 2 weeks)


Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24 ]
  2. Incidence of serious adverse events (SAEs) [ Time Frame: Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24 ]
  3. Response rate [ Time Frame: Week 24 ]
  4. Progression free survival [ Time Frame: Week 24 ]
  5. Overall survival [ Time Frame: Week 24 ]
  6. Incidences of myelosuppression [ Time Frame: Weeks Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24 ]
  7. Change in white blood cells (WBCs) level at all post-treatment visits compared to baseline [ Time Frame: Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24 ]
  8. Change in platelet level at all post-treatment visits compared to baseline [ Time Frame: Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24 ]
  9. Change in hemoglobin level at all post-treatment visits compared to baseline [ Time Frame: Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24 ]
  10. Change in serum inflammatory cytokines level at all post-treatment visits compared to baseline [ Time Frame: Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24 ]
  11. Change in serum c-reactive protein level at all post-treatment visits compared to baseline [ Time Frame: Weeks 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24 ]
  12. Changes in global health/QoL standardized score at post-treatment visits compared to baseline [ Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects aged at least 20 years old
  2. 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
  3. Subjects may be treatment naïve, or may have received therapy for colorectal cancer.
  4. ECOG performance status ≤ 2 and life expectancy ≥ 12 months Note: ECOG = Eastern Cooperative Oncology Group
  5. Dated and signed informed consent

Exclusion Criteria:

  1. Primary CNS malignancies or clinically active CNS metastases Note: CNS = central nervous system
  2. Ascertained hypersensitivity to any component of investigational product or FOLFOX + Bevacizumab/Cetuximab that the subject will be treated
  3. Any of the following hematologic abnormalities:

    1. Hemoglobin < 10.0 g/dL,
    2. ANC < 1,500/μL,
    3. Platelets < 100,000 /μL Note: ANC = absolute neutrophil count
  4. Any of the following serum chemistry abnormalities:

    1. Total bilirubin > 1.5 × ULN,
    2. AST or ALT > 2.5 × ULN,
    3. Gamma-GT > 2.5 x ULN,
    4. Alk-P > 2.5 x ULN,
    5. serum albumin < 3.0 g/dL,
    6. creatinine > 1.5 × ULN,
    7. 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

  5. Requirement for ongoing systemic steroid, or immunosuppressive agents
  6. Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily oral LEAC-102 treatment
  7. Active clinically serious infection
  8. Known history of HIV or hepatitis B or C Note: HIV = human immunodeficiency virus
  9. Uncontrolled psychiatric disorder or altered mental status precluding informed consent or necessary testing
  10. Consumption of herbal preparations/supplements (except for a daily multivitamin/mineral supplement not containing herbal components) within 2 weeks prior to the start of Cycle 1 of FOLFOX + Bevacizumab/Cetuximab administration
  11. Significant cardiovascular disease, including:

    1. Active clinically symptomatic left ventricular failure
    2. Active hypertension (diastolic blood pressure > 100 mmHg). Subjects with a history of hypertension must have been on stable doses of anti-hypertensive drugs for ≥ 4 weeks prior to start of Cycle 1 of FOLFOX + Bevacizumab/Cetuximab administration
    3. Uncontrolled hypertension: Blood pressure >140/90 mmHg on more than 2 antihypertensive medications
    4. Myocardial infarction, severe angina, or unstable angina within 12 weeks prior to start of Cycle 1 of FOLFOX + Bevacizumab/Cetuximab administration
    5. History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)
  12. Significant gastrointestinal disorder(s) that would, in the opinion of the Principal Investigator, prevent absorption of an orally available agent
  13. Has received an investigational agent within 4 weeks of entering this study
  14. With any condition judged by the investigator that entering the trial may be detrimental to the subject

15 Female with childbearing potential who is lactating or has positive urine pregnancy test at Screening visit

16. Subject with either gender refuses to adopt at least two forms of birth control (at least one of which must be a barrier method) during the study and until 30 days after study treatment.

Note: Acceptable forms include:

  1. Established use of oral, injected or implanted hormonal methods of contraception.
  2. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
  3. Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository

17. Subjects with grade 2 or above chronic neuropathy

18. Subjects with known dihydropyrimidine dehydrogenase (DPD) deficiency.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826837


Contacts
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Contact: Cora Chen, Ph.D, +886-978723555 cora_chen@twleaderlife.com

Sponsors and Collaborators
Taiwan Leader Biotech Corp.
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Responsible Party: Taiwan Leader Biotech Corp.
ClinicalTrials.gov Identifier: NCT02826837    
Other Study ID Numbers: LEAC-102-01
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taiwan Leader Biotech Corp.:
Advanced Colorectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors