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

Advanced Solid Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394144
• Other study ID #: D5660C00017
• Status: Completed
• Phase: Phase 1
• Start date: January 30, 2018
• Est. completion date: April 12, 2019

Study information

• Verified date: June 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 12, 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 120 Years

Eligibility

Key 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

Key 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.

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Research Site	Kashiwa
Japan	Research Site	Matsuyama-shi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability in terms of adverse events	Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters	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.
Secondary	Maximum plasma concentration (Cmax)	Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.	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.
Secondary	Overall response rate	Defined as the proportion of subjects who achieve a response.	Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.
Secondary	Duration of Response	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.	Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.
Secondary	Area under the plasma concentration-time curve (AUC)	PK parameters will be derived using standard non-compartmental methods.	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.