Clinical trial · Interventional
Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918
A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6918 Administered Daily as a Single Agent and in Combination Treatment in Adult Patients With Refractory 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): PK results demonstrate low and variable plasma concentrations so that achieving therapeutic concentrations is unlikely.
Summary
Brief summary (as posted)
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.
Conditions
Conditions (3)
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 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD6918 | Drug | — | UNRESOLVED |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- gemcitabine
- description
- gemcitabine administered in combination with AZD6918
- interventionNames
- Drug: gemcitabine
- type
- EXPERIMENTAL
- label
- pemetrexed
- description
- pemetrexed administered in combination with AZD6918
- interventionNames
- Drug: pemetrexed
- type
- EXPERIMENTAL
- label
- AZD6918
- description
- AZD6918 administered alone
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced solid tumors for which standard treatment does not exist or is no longer effective. * For chemotherapy combination treatment, must be suitable for treatment with either gemcitabine or pemetrexed. * Relatively good overall health other than cancer. Exclusion Criteria: * Poor bone marrow function (not producing enough blood cells). * Poor liver or kidney function. * Serious heart conditions * History of uncontrolled epilepsy, Parkinson's disease, Alzheimer's disease, brain tumor or any uncontrolled psychiatric or nervous system condition
References
Publications (0)
Data not yet available