A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients with Advanced Solid Tumours
Study identifier:D4190C00002
ClinicalTrials.gov identifier:NCT01938612
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients with Advanced Solid Tumours
Medical condition
Advanced Solid Tumors
Phase
Phase 1
Healthy volunteers
No
Study drug
MEDI4736, tremelimumab
Sex
All
Actual Enrollment
269
Study type
Interventional
Age
20 Years - 130 Years
Date
Study Start Date: 12 Sept 2013
Primary Completion Date: 01 Mar 2018
Study Completion Date: 25 Nov 2020
Study design
Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2022 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI4736 Q2W Evaluate MEDI4736 given every 2 weeks | Drug: MEDI4736 MEDI4736 will be administered by IV infusion every 14, 21 or 28 days. |
| Experimental: MEDI4736 Q3W Evaluate MEDI4736 given every 3 weeks | Drug: MEDI4736 MEDI4736 will be administered by IV infusion every 14, 21 or 28 days. |
| Experimental: MEDI4736 Dose Expansion evaluate MEDI4736 given every 2 weeks | Drug: MEDI4736 MEDI4736 will be administered by IV infusion every 14, 21 or 28 days. |
| Experimental: MEDI4736 Q4W Evaluate MEDI4736 given every 4 weeks | Drug: MEDI4736 MEDI4736 will be administered by IV infusion every 14, 21 or 28 days. |
| Experimental: MEDI4736 combined with another drug evaluate MEDI4736 in combination with another drug given every 4 weeks | Drug: tremelimumab tremelimumab is administered by IV infusion every 4 weeks |
Contacts
Investigators
Principal Investigator
Robert Iannone
Astrazeneca
