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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT03394144

Collaborator

(none)

Enrollment

Locations

Arm

14.4

Actual Duration (Months)

5.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Malignancies	Drug: AZD9150, Durvalumab	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 30, 2018

Actual Primary Completion Date :

Apr 12, 2019

Actual Study Completion Date :

Apr 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: C1:AZD9150, C2:AZD9150+Durvalumab After confirmed safety with Cohort 1, Cohort 2 will open	Drug: AZD9150, Durvalumab After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT

Arm

Intervention/Treatment

Experimental: C1:AZD9150, C2:AZD9150+Durvalumab

After confirmed safety with Cohort 1, Cohort 2 will open

Drug: AZD9150, Durvalumab

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Kashiwa		Japan	277-8577
2	Research Site	Matsuyama-shi		Japan	791-0280

Sponsors and Collaborators

AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT03394144

Other Study ID Numbers:

D5660C00017

First Posted:

Jan 9, 2018

Last Update Posted:

Jun 24, 2019

Last Verified:

Jun 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Durvalumab

Study Results

No Results Posted as of Jun 24, 2019