38-502:BRAFTOVI/MEKTOVI Combination Therapy Specified Drug Use Survey(CRC)

38-502 : BRAFTOVI/MEKTOVI Combination Therapy Specified Drug Use Survey (Unresectable advanced or recurrent BRAF-mutant colorectal cancer that has progressed following chemotherapy)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2011210012

Enrollment

220

Registered

2021-05-25

Start date

2021-03-12

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

unresectable advanced or recurrent BRAF-mutant colorectal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients with unresectable advanced or recurrent BRAF-mutant colorectal cancer that has progressed following chemotherapy for whom BRAFTOVI/MEKTOVI Combination Therapy is performed

Exclusion criteria

Exclusion criteria: patients who have not received BRAFTOVI and/or MEKTOVI

Design outcomes

Primary

Measure	Time frame
[Safety]Occurrence status of adverse drug reactions and infections, Occurrence status of adverse drug reactions corresponding to specified safety concerns, Factors that are considered to affect safety Specified safety concerns: Cutaneous malignancies, palmar-plantar erythrodysaesthesia syndrome, eye disorders, cardiac dysfunction, hypertension, rhabdomyolysis, hepatic dysfunction, and haemorrhage [Efficacy]Antitumor effect and overall survival (OS)	—

Measure

Time frame

[Safety]Occurrence status of adverse drug reactions and infections, Occurrence status of adverse drug reactions corresponding to specified safety concerns, Factors that are considered to affect safety Specified safety concerns: Cutaneous malignancies, palmar-plantar erythrodysaesthesia syndrome, eye disorders, cardiac dysfunction, hypertension, rhabdomyolysis, hepatic dysfunction, and haemorrhage [Efficacy]Antitumor effect and overall survival (OS)

—

Contacts

Public ContactTakafumi Nakao

Ono Pharmaceutical Co.,LTD

pms_contact_ml@ono-pharma.com+81-662225501

Outcome results