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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C1:AZD9150, C2:AZD9150+Durvalumab | Experimental | After confirmed safety with Cohort 1, Cohort 2 will open |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD9150, Durvalumab | Drug | After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Kashiwa | 277-8577 | Japan | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36270753 | Derived | 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. |
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| ID | Term |
|---|---|
| C000610954 | danvatirsen |
| C000613593 | durvalumab |
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| 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. |
| 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. |
| 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. |
| Matsuyama |
| 791-0280 |
| Japan |