Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies

Sponsor
AstraZeneca
Study ID
NCT03394144
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Malignancies

Eligibility Criteria

Sex
ALL
Age
20 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD9150, Durvalumab — DRUG
    After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT

Study Details

This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.

Key Dates

Start date
Jan 30, 2018
Status verified
Jun 2019
Primary completion
Apr 12, 2019
Completion
Apr 12, 2019

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: C1:AZD9150, C2:AZD9150+Durvalumab
    After confirmed safety with Cohort 1, Cohort 2 will open

Primary Outcome Measure

Safety and tolerability in terms of adverse events [ Time Frame: From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months. ]

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