TMX-67TLS Phase3 study

A phase 3, randomized, open-label, multi-center clinical study to observe the efficacy and safety of TMX-67 compared to allopurinol in patients with a malignant tumor receiving chemotherapy

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222348

Enrollment

100

Registered

2013-12-26

Start date

2013-12-26

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

Hyperuricemia associated with cancer chemotherapy

Interventions

investigational material(s) Generic name etc : TMX-67 INN of investigational material : Febuxostat Therapeutic category code : 394 Agents for treatment of gout Dosage and Administration for Investigat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with intermediate or high risk of tumor lysis syndrome (TLS)

Exclusion criteria

Exclusion criteria: 1)Patients with diagnosis of Laboratory TLS (LTLS) or Clinical TLS (CTLS). 2)Patients with severe hepatic insufficiency. 3)Patients with severe renal insufficiency. 4)Performance status of 3 to 4. etc

Design outcomes

Secondary

Measure	Time frame
Assessment of LTLS and CTLS through the treatment period	—

Primary

Measure	Time frame
Area under the curve of serum uric acid (sUA) from baseline to the evaluation visit	—

Outcome results

None listed

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