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

JRCT ID: jRCT2011210012

Registered date:25/05/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: unresectable advanced or recurrent BRAF-mutant colorectal cancer
• Date of first enrollment: 12/03/2021
• Target sample size: 220
• Study type: Observational

Outcome(s)

Primary Outcome

[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)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include 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
• Exclude criteria: patients who have not received BRAFTOVI and/or MEKTOVI

Related Information

• Primary Sponsor: Kuro Toshihiko