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COMPLETEDPHASE1

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

A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies

NCT03394144•AstraZeneca

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

20 - 120 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female patients must be at least 20 years of age.
•Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.
•Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).
•Adequate organ and marrow function
•Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol

Exclusion Criteria

•Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.
•Patients must have completed any previous cancer-related treatments before enrolment.
•Has active or prior autoimmune disease within the past 2 years
•Has active or prior inflammatory bowel disease or primary immunodeficiency
•Undergone an organ transplant that requires use of immunosuppressive treatment
•Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG
•Prior exposure to AZD9150 or any other anti PD (L)1 antibody.

Locations (2)

Research Site

Kashiwa, Japan

Research Site

Matsuyama, Japan

Key Dates

Start Date

January 30, 2018

Primary Completion Date

April 12, 2019

Completion Date

April 12, 2019

Last Updated

June 24, 2019

Enrollment

ACTUAL participants

Conditions

Advanced Solid Malignancies

Interventions

AZD9150, Durvalumab

DRUG

Phase I/Ib Trial of TIraGolumab, AtEzolizumab, and RadScopal Radiation in Patients With Advanced Solid Malignancies (TIGER)

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Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Phase I/Ib Trial of TIraGolumab, AtEzolizumab, and RadScopal Radiation in Patients With Advanced Solid Malignancies (TIGER)

Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies

Drug-drug Interaction Study With AZD5305 and Itraconazole in Patients With Advanced Solid Malignancies

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