Pharmacokinetics of Regorafenib by endogenous cortisol 6beta-hydroxylation clearance and potential of personalized use.

Pharmacokinetics of Regorafenib by endogenous cortisol 6beta-hydroxylation clearance and potential of personalized use. - PK study of Regorafenib

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016747

Enrollment

Registered

2015-03-09

Start date

2014-11-17

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, GIST

Interventions

Administration of regorafenib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with histopathologically confirmed colorectal cancer or GIST. 2. Completed prior chemotherapy more than 14 days and resolved toxicity to <= Grade1. 3. Patients 20 years or older. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. 5. Survival more than 3 months. 6. Adequate organ functions (listed below) are preserved within 7 days prior to initiation of study treatment. i. Neutrophil >=1,500/mm3 ii. Hemoglobin >=9.0 g/dl iii. Platelets >=100,000/mm3 iv. Total bilirubin <= 2.0 ml/dl v. AST and ALT <= 100 IU/l vi. Serum creatinine <= 1.5 mg/dl vii. Systolic blood pressure < 150 mmHg and diastolic blood pressure < 90 mmHg. 7. Patients with written informed consent.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled infection(exclude hepatitis B and C ). 2. With unstable angina and cardiac infarction within 6 months. 3. With arterial or venous thrombotic or embolic events such as cerebrovascular accident, pulmonary embolism, deep vein thrombosis within 6 months. 4. Any surgical treatments within 4 weeks. 5. With a history of severe systemic diseases such as uncontrolled diabetes mellitus, cirrhosis. 6. With active multiple cancer. 7. Clinically significant mental disorder. 8. Pregnant or lactating women or women of childbearing potential. 9. Taking CYP3A4 inhibitors or inducers(eg, phenytoin, carbamazepine, rifampin, phenobarbital, ketoconazole, macrolide antibiotics). If administration is stopped even before a week of study treatment, eligible is possible. 10. patients with administration of steroids. 11. Other conditions not suitable for this study.

Design outcomes

Primary

Measure	Time frame
Adverse events	—

Secondary

Measure	Time frame
OS PFS RR	—

Countries

Japan

Contacts

Public ContactNaohiro Okano

School of Medicine, Kyorin University Department of Internal Medicine, Medical Oncology

naohiro-okano@ks.kyorin-u.ac.jp0422-47-5511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026