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
- Advanced solid tumors for which standard treatment does not exist or is no longer
- For chemotherapy combination treatment, must be suitable for treatment with either
gemcitabine or pemetrexed.
- Relatively good overall health other than cancer.
- 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
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, Karnofsky performance status
Outcome Time Frame:
Weekly for first two treatment cycles, then every 2-4 weeks
Judith Ochs, MD
United States: Food and Drug Administration
- Solid Tumors
- Advanced Solid Malignancies
- Phase I,
- solid tumors,
- advanced solid malignancies,
- dose escalation,
- combination treatment,
- TRK inhibitor