Clinical trial · Interventional
Human ADME Study of [14C]-AZD1390
A Phase I, Open-label Study to Assess the Absorption, Distribution, Metabolism, and Excretion (ADME) of AZD1390 After a Single Oral Dose of [14C]-AZD1390 in Participants With Advanced Solid Malignancies
NCT07643870CI-TRIAL-00114624not yet recruitingPhase 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)
This is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of \[14C\]-AZD1390.
Conditions
Conditions (1)
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 | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD1390 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AZD1390
- description
- Single dose of \[14C\]-AZD1390
- interventionNames
- Drug: AZD1390
Primary outcomes (38)
- measure
- The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
- timeFrame
- 6 Weeks
- description
- Amount excreted (Ae) (urine)
- measure
- The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
- timeFrame
- 6 Weeks
- description
- Cumulative Amount excreted (CumAe) (urine)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, no active anticancer treatment, * ECOG performance status of 0 or 1 with no deterioration over the 2 weeks, * Predicted life expectancy ≥ 12 weeks, * Adequate organ and marrow function, * Creatinine clearance ≥ 50 mL/min, * Regular bowel movements, * No cancer-associated cachexia (weight loss). Exclusion Criteria: * History or presence of myopathy or raised CK \> 5 × ULN at screening, * History of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, * History or presence of clinically significant hepatic disease, * History of epileptic disorder or any seizure history unrelated to tumour, * History of MDS/AML or with features suggestive of MDS/AML, * Predisposition to bleeding * History of persisting (\> 2 weeks) severe cytopenia * Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection * History of another primary malignancy * Persistent toxicities (CTCAE Grade ≥ 2), excluding alopecia, caused by previous anticancer therapy, * Spinal cord compression or brain metastases for at least 4 weeks
References
Publications (0)
Data not yet available
No reference posted for this study.