Clinical trial · Interventional
Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Patients With Advanced Solid Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Termination of study enrolment to Part C, Cohort 3 (08 July 2013) was based on the analysis of data from Study D2610C00004. Data were available from 33 patient
Summary
Brief summary (as posted)
This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.
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 (3)
- type
- EXPERIMENTAL
- label
- Part A
- description
- Ascending doses of AZD4547 administered orally to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD)
- interventionNames
- Drug: AZD4547
- type
- EXPERIMENTAL
- label
- Part B
- description
- Dose expansion phase, at the RD defined in Part A
- interventionNames
- Drug: AZD4547
- type
- EXPERIMENTAL
- label
- Part C
- description
- Expansion phase in patients with FGFR1 and FGFR2 amplified tumours commencing at the RD defined from Part A
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 149 Years
Show eligibility criteria text
Inclusion Criteria: * Minimum life expectancy of 12 weeks * The presence of a solid, malignant tumour that is resistance to standard therapies or for which no standard therapies exist * In the expansion for the study patients must have a tumour at least 1cm in size that can be measure using a CT or MRI scan, and provide a tumour sample to the sponsor company for testing of FGFR1 and/or 2 amplification * Expansion, 5 groups of advanced cancer * Solid tumours,FGFR1 and/or FGFR2 gene amplified * Squamous NSCLC, FGFR1 gene low \& high amplified * Gastric adenocarcinoma, including the lower oesophagus/gastro-oesophageal junction, FGFR2 gene low \& high amplified * Aged at least 25 years Exclusion Criteria: * Treatment with any other chemotherapy, immunotherapy or anticancer agents within 3 weeks before the first dose of study * An inability to be able to take the study medication * A bad reaction to AZD4547 or any drugs similar to it in structure or class.
References
Publications (0)
Data not yet available