Clinical trial · Interventional
Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Japanese Patients With Advanced Solid Malignancies
NCT01213160CI-TRIAL-00022765completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary purpose of this study is to explore the safety and tolerability of AZD4547 in Japanese patients with advanced solid malignancies.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Malignancies | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD4547 | Drug | Fexagratinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AZD4547
- interventionNames
- Drug: AZD4547
Primary outcomes (18)
- measure
- Assessment of adverse events (based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)general examination
- timeFrame
- General examination prior to IP administration in treatment cycles
- measure
- Assessment of adverse events (based on CTCAE version 4.0)general examination
- timeFrame
- General examination on day 1 in cycle 0
- measure
- Assessment of adverse events (based on CTCAE version 4.0)general examination
- timeFrame
- General examination day 21 in cycle 1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 150 Years
Show eligibility criteria text
Inclusion Criteria: \- Japanese patients with advanced solid malignancies Over 25 years old Relatively good overall health other than cancer Exclusion Criteria: \- Poor bone marrow function (not producing enough blood cells). Poor liver or kidney function. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the IP or previous significant bowel resection.
References
Publications (1)
- DERIVEDSaka H, Kitagawa C, Kogure Y, Takahashi Y, Fujikawa K, Sagawa T, Iwasa S, Takahashi N, Fukao T, Tchinou C, Landers D, Yamada Y. Safety, tolerability and pharmacokinetics of the fibroblast growth factor receptor inhibitor AZD4547 in Japanese patients with advanced solid tumours: a Phase I study. Invest New Drugs. 2017 Aug;35(4):451-462. doi: 10.1007/s10637-016-0416-x. Epub 2017 Jan 10. PMID 28070720