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Advanced Colorectal CancerPhase 1/2NCT02826837

LEAC-102 for Advanced Colorectal Cancer

A Phase 1/2 study testing LEAC-102 500mg capsule and FOLFOX + Bevacizumab/Cetuximab in people with Advanced Colorectal Cancer, run by Taiwan Leader Biotech Corp..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Advanced Colorectal Cancer
What is being tested?
LEAC-102 500mg capsule and FOLFOX + Bevacizumab/Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Sep 2022to 1 Feb 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 38Show fewer
  • 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
  • Requirement for ongoing systemic steroid, or immunosuppressive agents
  • Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily oral LEAC-102 treatment
  • Active clinically serious infection
  • Known history of HIV or hepatitis B or C Note: HIV = human immunodeficiency virus
  • Uncontrolled psychiatric disorder or altered mental status precluding informed consent or necessary testing
  • 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
  • Significant cardiovascular disease, including:
  • Active clinically symptomatic left ventricular failure
  • 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
  • Uncontrolled hypertension: Blood pressure >140/90 mmHg on more than 2 antihypertensive medications
  • Myocardial infarction, severe angina, or unstable angina within 12 weeks prior to start of Cycle 1 of FOLFOX + Bevacizumab/Cetuximab administration
  • History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)
  • Significant gastrointestinal disorder(s) that would, in the opinion of the Principal Investigator, prevent absorption of an orally available agent
  • Has received an investigational agent within 4 weeks of entering this study
  • 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:
  • Established use of oral, injected or implanted hormonal methods of contraception.
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
  • 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.

Trial locations and contacts

No sites are listed yet.

Cora Chen, Ph.D, contact

+886-978723555

cora_chen@twleaderlife.com

About this study

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

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

Being tested
LEAC-102 500mg capsule and FOLFOX + Bevacizumab/Cetuximab
Keywords
Advanced Colorectal Cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LEAC-102 500mg capsule and FOLFOX + Bevacizumab/CetuximabDrug

    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)

Study groups in NCT02826837
Study groupRoleWhat they receive
LEAC-102 and FOLFOX+Bevacizumab/CetuximabExperimentalThe 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)
Receives: Drug: LEAC-102 500mg capsule and FOLFOX + Bevacizumab/Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose

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

    Measured: Week 4

Secondary outcomes (12)

  1. Incidence of adverse events (AEs)

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

  2. Incidence of serious adverse events (SAEs)

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

  3. Response rate

    Measured: Week 24

  4. Progression free survival

    Measured: Week 24

  5. Overall survival

    Measured: Week 24

  6. Incidences of myelosuppression

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22,24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2016 (estimated)
  2. Study start1 Sep 2022 (estimated)
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion1 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02826837
Sponsor's protocol ID
LEAC-102-01
Status last verified
Sep 2021
First submitted
7 Jun 2016
Last updated
6 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LEAC-102 500mg capsule and FOLFOX + Bevacizumab/Cetuximab in people with Advanced Colorectal Cancer, run by Taiwan Leader Biotech Corp..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cora Chen, Ph.D, (+886-978723555, cora_chen@twleaderlife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (time frame: Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02826837.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.

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