A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients With Advanced Solid Tumours
NCT01938612 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 269
Last updated 2021-03-12
Summary
This is a phase I, open-label, multicentre study of MEDI4736 administered intravenously with a standard 3+3 dose-escalation phase to evaluate safety, tolerability, and pharmacokinetics in patients with advanced solid tumor followed by an expansion phase in patients with advanced solid tumors.
Conditions
Interventions
- DRUG
-
MEDI4736
MEDI4736 will be administered by IV infusion every 14, 21 or 28 days.
- DRUG
-
tremelimumab
tremelimumab is administered by IV infusion every 4 weeks
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Robert Iannone, MD · AstraZeneca
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 130 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-09-12
- Primary Completion
- 2018-03-01
- Completion
- 2020-11-25
Countries
- Japan
- South Korea
- Taiwan
Study Locations
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