A clinical pharmacology study of CH5424802 (JP28927)

A clinical pharmacology study of CH5424802 in patients with ALK-positive NSCLC

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222140

Enrollment

Registered

2013-07-10

Start date

2013-07-10

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

Non-small cell lung cancer

Interventions

investigational material(s) Generic name etc : CH5424802 (AF802) INN of investigational material : alectinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Invest

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -NSCLC -ECOG PS 0-1 -ALK-positive

Exclusion criteria

Exclusion criteria: -Prior treatment with CH5424802 -Meningeal metastases or brain metastases that are symptomatic or requiring treatment -Pregnatnt or lactating women

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics, safety PK: PK parameters (AUC, Cmax), Safety; adverse events, laboratory data	—

Secondary

Measure	Time frame
Response rate Measured by RECIST v1.1	—

Outcome results

None listed

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