Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies
- Registration Number
- NCT03394144
- Lead Sponsor
- AstraZeneca
- 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 Japanese patients with advanced solid malignancies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description C1:AZD9150, C2:AZD9150+Durvalumab AZD9150, Durvalumab After confirmed safety with Cohort 1, Cohort 2 will open
- Primary Outcome Measures
Name Time Method Safety and tolerability in terms of adverse events 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. Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
- Secondary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax) From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months. Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.
Overall response rate Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months. Defined as the proportion of subjects who achieve a response.
Duration of Response Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months. Defined as the interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause.
Area under the plasma concentration-time curve (AUC) From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months. PK parameters will be derived using standard non-compartmental methods.
Trial Locations
- Locations (1)
Research Site
🇯🇵Matsuyama-shi, Japan