Advanced Solid MalignanciesPhase 1NCT03394144
Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies
A Phase 1 study testing AZD9150, Durvalumab in people with Advanced Solid Malignancies, run by AstraZeneca at 2 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 to 120 years
- Conditions the study is for
- Advanced Solid Malignancies
- What is being tested?
- AZD9150, Durvalumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesJapan
- Study dates
- 30 Jan 2018to 12 Apr 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
- Conditions
- Advanced Solid Malignancies
- Being tested
- AZD9150, Durvalumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9150, DurvalumabDrug
After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT
| Study group | Role | What they receive |
|---|---|---|
| C1:AZD9150, C2:AZD9150+Durvalumab | Experimental | After confirmed safety with Cohort 1, Cohort 2 will open Receives: Drug: AZD9150, Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.
Measured: 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
Defined as the proportion of subjects who achieve a response.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start30 Jan 2018
- Primary completion12 Apr 2019
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid MalignanciesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394144
- Sponsor's protocol ID
- D5660C00017
- Status last verified
- Jun 2019
- First submitted
- 10 Nov 2017
- Last updated
- 24 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36270753
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03394144
- Acronym / sponsor ID
- D5660C00017
- Conditions
- Advanced Solid Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C1:AZD9150, C2:AZD9150+Durvalumab | Experimental | Drug: AZD9150, DurvalumabAfter confirmed safety with Cohort 1, Cohort 2 will open |
Who may qualify
- Ages
- 20 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD9150, DurvalumabAfter confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT | Drug | C1:AZD9150, C2:AZD9150+Durvalumab |
Primary outcome
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
4 secondary outcomes
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.
Overall response rate
Time frame: Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.
Duration of Response
Time frame: 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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Derived from this study: PubMed 36270753Nishina 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD9150, Durvalumab in people with Advanced Solid Malignancies, run by AstraZeneca at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03394144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019.