NCT03394144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2019

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

1.2 years

First QC Date

November 10, 2017

Last Update Submit

June 21, 2019

Conditions

Advanced Solid Malignancies

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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.

  • Overall response rate

    Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.

  • Duration of Response

    Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.

  • 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.

Study Arms (1)

C1:AZD9150, C2:AZD9150+Durvalumab

EXPERIMENTAL

After confirmed safety with Cohort 1, Cohort 2 will open

Drug: AZD9150, Durvalumab

Interventions

AZD9150, DurvalumabDRUG

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

C1:AZD9150, C2:AZD9150+Durvalumab

Eligibility Criteria

Age20 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Kashiwa, 277-8577, Japan

Location

Research Site

Matsuyama, 791-0280, Japan

Location

Related Publications (1)

  • Nishina T, Fujita T, Yoshizuka N, Sugibayashi K, Murayama K, Kuboki Y. Safety, tolerability, pharmacokinetics and preliminary antitumour activity of an antisense oligonucleotide targeting STAT3 (danvatirsen) as monotherapy and in combination with durvalumab in Japanese patients with advanced solid malignancies: a phase 1 study. BMJ Open. 2022 Oct 21;12(10):e055718. doi: 10.1136/bmjopen-2021-055718.

    PMID: 36270753DERIVED

MeSH Terms

Interventions

danvatirsendurvalumab

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2017

First Posted

January 9, 2018

Study Start

January 30, 2018

Primary Completion

April 12, 2019

Study Completion

April 12, 2019

Last Updated

June 24, 2019

Record last verified: 2019-06

Locations

JP(2)