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Active, Not Recruiting

NCT Number: NCT06547385

Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer

To evaluate the tolerability and safety of combination of ONO-4578 and ONO-4538 and the standard of care XELOX + bevacizumab or the safety of combination of ONO-4578 and ONO-4538 and the standard of care FOLFOX + bevacizumab as first-line therapy in patients with unresectable, advanced, or recurrent colorectal cancer.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unresectable colorectal cancer
  • Life expectancy of at least 3 months
  • Patients with ECOG performance status 0 or 1

Exclusion criteria

  • Patients with severe complication
  • Patients are unable to swallow oral medications

Treatment and study plan

ONO-4578

Drug

Specified dose on specified days

ONO-4538

Drug

Specified dose on specified days

Other names: Nivolumab

Capecitabine

Drug

Specified dose on specified days

Other names: XELODA

Oxaliplatin

Drug

Specified dose on specified days

Other names: ELPLAT

Fluorouracil

Drug

Specified dose on specified days

Other names: 5-FU

Calcium Levofolinate Hydrateb

Drug

Specified dose on specified days

Other names: ISOVORIN

Bevacizumab

Drug

Specified dose on specified days

Other names: AVASTIN

Primary outcomes

  1. Incidence and severity of AEs and SAEs

    Time frame: up to 3years

  2. Incidence and severity of clinical laboratory abnormalities

    Time frame: up to 3years

  3. 12-lead electrocardiography (Heart rate)

    Time frame: up to 3years

  4. 12-lead electrocardiography (PR interval)

    Time frame: up to 3years

  5. 12-lead electrocardiography (RR interval)

    Time frame: up to 3years

  6. 12-lead electrocardiography (QRS width)

    Time frame: up to 3years

  7. 12-lead electrocardiography (QT interval)

    Time frame: up to 3years

  8. Chest X-ray test

    Time frame: up to 3years

  9. ECOG performance status

    Time frame: up to 3years

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: up to 3years

  2. Disease control rate (DCR)

    Time frame: up to 3years

  3. Overall survival (OS)

    Time frame: up to 3years

  4. Progression-free survival (PFS)

    Time frame: up to 3years

  5. Duration of response (DOR)

    Time frame: up to 3years

  6. Time to response (TTR)

    Time frame: up to 3years

  7. Best oveall response (BOR)

    Time frame: up to 3years

  8. Percentage of change in the sum of tumor diameters of target lesions

    Time frame: up to 3years

  9. Maximum percent change in the sum diameters of the target lesions

    Time frame: up to 3years

  10. Time course of tumor markers

    Time frame: up to 3years

  11. Plasma ONO-4578 concentration

    Time frame: up to 3years

  12. Serum ONO-4538 concentration

    Time frame: up to 3years

  13. Anti-ONO-4538 antibody

    Time frame: up to 3years

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

ONO-4578 Phase I Study An Open-label, Uncontrolled Study of First-line Combination Therapy of ONO-4578 and ONO-4538 With Standard Therapy XELOX Plus Bevacizumab or FOLFOX Plus Bevacizumab in Patients With Unresectable, Advanced or Recurrent Colorectal Cancer

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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