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NCT Number: NCT07035886

A Study to Monitor the Fruzaqla Treatment of Adults With Metastatic Colorectal Cancer (mCRC) in South Korea

The purpose of this study is to estimate the proportion of all adverse events (AEs) including serious adverse events (SAEs) occurring with the use of fruquintinib among adult participants who have been administered fruquintinib as per the approved indications.

Recruiting

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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

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonsei University Hospital

Seoul, 03722, South Korea

Location status: Recruiting

Location contact

Beom Seung-Hoon

PRINCIPAL_INVESTIGATOR

Site Contact

CONTACT

[email protected]

82-10-3356-7610

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age greater than or equal to (>=)18 years.
  • Participants who are initiate treatment or will be treated with Fruzaqla according to the approved label of South Korea.
  • Participant voluntarily consent to participate in the study.

Exclusion criteria

  • Participants for whom Fruzaqla is contraindicated or those with risks that should avoid starting Fruzaqla, as per the product label.
  • Participants actively participating in other interventional clinical trial(s) on mCRC treatments.
  • Pregnant or breastfeeding women.

Treatment and study plan

No intervention

Other

As this is an observational study, no intervention will be administered.

Primary outcomes

  1. Number of Participants with Any Adverse Events (AEs), Adverse Drug Reaction (ADRs), Expected and Unexpected AEs and ADRs

    Time frame: Up to approximately 6 years

  2. Number of Participants with Any Serious Adverse Events (SAEs), Serious Adverse Drug Reaction (SADRs), Expected and Unexpected SAEs and SADRs, AEs Leading to Death

    Time frame: Up to approximately 6 years

  3. Number of Participants with AEs with Grade 3 or Higher

    Time frame: Up to approximately 6 years

  4. Number of Participants who Reported the Events Related to Important Risks in the Risk Management Plan (RMP)

    Time frame: Up to approximately 6 years

Secondary outcomes

  1. Overall Survival (OS) Rate

    Time frame: Up to 6 months

    OS rate is the percentage of participants who are alive for 6 months after their start date of Fruzaqla capsule.

  2. Progression Free Survival (PFS) Rate

    Time frame: Up to 6 months

    PFS rate is the percentage of participants who have not experienced progression or death for 6 months after their start date of Fruzaqla capsule.

  3. Objective Response Rate (ORR)

    Time frame: Up to 18 treatment cycles (approximately up to 18 months)

    ORR is defined as the percentage of participants achieving a best response of complete response (CR) or partial response (PR).

  4. Disease Control Rate (DCR)

    Time frame: Up to 18 treatment cycles (approximately up to 18 months)

    DCR is defined as the percentage of participants achieving a best response of CR, PR, or Stable Disease (SD).

  5. Median Overall Survival (mOS)

    Time frame: Up to 18 treatment cycles (approximately up to 18 months)

    OS will be defined as the time from the start date of Fruzaqla to the date of death from any cause. The mOS is the time at which 50% of participants are expected to have died from any cause.

  6. Median Progression Free Survival (mPFS)

    Time frame: Up to 18 treatment cycles (approximately up to 18 months)

    PFS will be defined as the time from the start date of Fruzaqla capsule to the date of documented progression or death from any cause. Tumor assessment will be performed by routine clinical practice of the investigators. The mPFS is the time at which 50% of participants are expected to have experienced disease progression or died from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Post-Marketing Surveillance (Usage Results Study) of Fruzaqla Capsule (Fruquintinib) for the Approved Indications in South Korea

Important dates

Study start
2025
Primary completion
2029
Study completion
2031
First posted
Jun 25, 2025
Registry last updated
Feb 27, 2026

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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