Study to Assess the Safety and Preliminary Efficacy of AZD0156 at Increasing Doses Alone or in Combination With Other Anti-cancer Treatment in Patients With Advanced Cancer
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- AstraZeneca
- Study ID
- NCT02588105
- Phase
- PHASE1
- Status
- Completed
Conditions
- Advanced Solid Tumours
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 130 Years
- Healthy Volunteers
- Not accepted
Interventions
- AZD0156 — DRUGAll patients will receive AZD0156 as a monotherapy or in combination to assess safety and tolerability.
- Olaparib — DRUGModule 1 combination with olaparib
- irinotecan — DRUGModule 2 combination with irinotecan/FOLFIRI
- Fluorouracil — DRUGModule 2 combination with irinotecan/FOLFIRI
- Folinic Acid — DRUGModule 2 combination with irinotecan/FOLFIRI
Study Details
The purpose of this study is to determine whether AZD0156 is safe, what is the best dose to give, and how it is processed by the body when given alone or in combination with other agents. The study will also collect some initial information about how effective it is.
Key Dates
- Start date
- Nov 10, 2015
- Status verified
- Sep 2022
- Primary completion
- Sep 13, 2019
- Completion
- Jul 26, 2022
Study Design
- Enrollment
- 84 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Safety and TolerabilityAll patients will receive AZD0156 as a monotherapy or in combination with either olaparib, cytotoxic chemotherapies, or novel anti-cancer agents to assess safety and tolerability
Primary Outcome Measure
Safety and tolerability - Number of patients experiencing adverse events [ Time Frame: Informed consent until end of Safety Follow-up (approximately 6 months) ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Aurora | Colorado | 80045 | - |
| Research Site | New York | New York | 10033 | - |
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