Status:
COMPLETED
Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies
Lead Sponsor:
AstraZeneca
Conditions:
Advanced Solid Malignancies
Eligibility:
All Genders
20-120 years
Phase:
PHASE1
Brief 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 Japane...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03394144
Start Date
January 30 2018
End Date
April 12 2019
Last Update
June 24 2019
Active Locations (2)
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1
Research Site
Kashiwa, Japan, 277-8577
2
Research Site
Matsuyama, Japan, 791-0280