The prospective study of the clinical efficacy/adverse event of regorafenib in unresectable metastatic and advanced colorectal cancer

The prospective study of the clinical efficacy/adverse event of regorafenib in unresectable metastatic and advanced colorectal cancer - Prediction of the Efficacy/Adverse event of Regorafenib in advanced Colorectal cancer (PEARC study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000015404

Enrollment

Registered

2014-10-10

Start date

2014-08-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Unresectable metastatic and advanced colorectal cancer. 2. with sufficient organ function. 3. with written informed consent.

Exclusion criteria

Exclusion criteria: 1. with potent drug affected activity of CYP3A4 or UGT1A9, and with potent drug affected blood concentration of regorafenib. 2. Pregnant female, possibly pregnant females and females feeding babies. 3. with uncontrollable hypertension (systolic >150 mmHg or diastolic >90 mmHg even with hypotensives) 4. with a history of embolism, ischemic heart disease, unstable angina, heart failure or cerebrovascular disease. 5. with severe allergy. 6. Any other patients whom the physician in charge of the study judges to be unsuitable.

Design outcomes

Primary

Measure	Time frame
To evaluate the association with clinical efficacy/adverse event of regorafenib	—

Secondary

Measure	Time frame
To explore the potent polymorphisms and biomarkers	—

Countries

Japan

Contacts

Public ContactHiroyuki Shibata

Akita University Hospital Department of Clinical Oncology

minoue@med.akita-u.ac.jp018-884-6262

Outcome results