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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01938612 on ClinicalTrials.gov