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
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- AstraZeneca
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, Karnofsky performance status
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
gemcitabine
gemcitabine administered in combination with AZD6918
Intervention: gemcitabine (Drug)
pemetrexed
pemetrexed administered in combination with AZD6918
Intervention: pemetrexed (Drug)
AZD6918
AZD6918 administered alone
Intervention: AZD6918 (Drug)
Outcomes
Primary Outcomes
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, Karnofsky performance status
Time Frame: Weekly for first two treatment cycles, then every 2-4 weeks
Secondary Outcomes
- Pharmacokinetic effect of AZD6918 when administered alone and in combination with chemotherapy(According to protocol specified schedule, the number of PK samples collected during Cycle 1 (up to 28 days) based on treatment with AZD6918 alone or in combination with chemotherapy)