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Completed

NCT Number: NCT03394144

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

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.

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Key information

Conditions

Advanced Solid Malignancies

Age range

20 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Kashiwa, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD9150, Durvalumab

Drug

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

Primary outcomes

  1. Safety and tolerability in terms of adverse events

    Time frame: 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 outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: 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.

  2. Overall response rate

    Time frame: 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.

  3. Duration of Response

    Time frame: 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.

  4. Area under the plasma concentration-time curve (AUC)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 9, 2018
Registry last updated
Jun 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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