An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer
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ClinicalTrials.gov Identifier: NCT04089553 |
Recruitment Status :
Active, not recruiting
First Posted : September 13, 2019
Results First Posted : July 8, 2022
Last Update Posted : January 13, 2023
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Prostate Cancer Metastatic Castration-Resistant Prostate Cancer (mCRPC) |
Interventions |
Drug: AZD4635 Drug: Oleclumab Drug: Durvalumab |
Enrollment | 59 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Module 1 (AZD4635 75 mg + Durvalumab 1500 mg) | Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg) |
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Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first. | Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first. |
Period Title: Overall Study | ||
Started | 29 | 30 |
Completed | 4 | 12 |
Not Completed | 25 | 18 |
Reason Not Completed | ||
Death | 12 | 11 |
Lost to Follow-up | 2 | 2 |
Progressive disease | 0 | 1 |
Withdrawal by Subject | 5 | 2 |
Other | 6 | 2 |
Baseline Characteristics
Arm/Group Title | Module 1 (AZD4635 75 mg + Durvalumab 1500 mg) | Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg) | Total | |
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Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first. | Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first. | Total of all reporting groups | |
Overall Number of Baseline Participants | 29 | 30 | 59 | |
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Safety analysis set included all participants who received at least one dose of study drug.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 29 participants | 30 participants | 59 participants | |
72.2 (7.10) | 72.7 (7.33) | 72.5 (7.16) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 29 participants | 30 participants | 59 participants | |
Female |
0 0.0%
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0 0.0%
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0 0.0%
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Male |
29 100.0%
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30 100.0%
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59 100.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 29 participants | 30 participants | 59 participants | |
Hispanic or Latino |
4 13.8%
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2 6.7%
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6 10.2%
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Not Hispanic or Latino |
24 82.8%
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28 93.3%
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52 88.1%
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Unknown or Not Reported |
1 3.4%
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0 0.0%
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1 1.7%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 29 participants | 30 participants | 59 participants | |
American Indian or Alaska Native |
0 0.0%
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1 3.3%
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1 1.7%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
5 17.2%
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3 10.0%
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8 13.6%
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White |
23 79.3%
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24 80.0%
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47 79.7%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
1 3.4%
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2 6.7%
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3 5.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Name/Title: | Global Clinical Lead |
Organization: | AstraZeneca Clinical Study Information Center |
Phone: | 1-877-240-9479 |
EMail: | information.center@astrazeneca.com |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT04089553 |
Other Study ID Numbers: |
D8731C00001 GU 156 ( Other Identifier: Sarah Cannon Development Innovations, LLC ) 264471 ( Other Identifier: Parexel International (IRL) Limited ) |
First Submitted: | August 29, 2019 |
First Posted: | September 13, 2019 |
Results First Submitted: | June 14, 2022 |
Results First Posted: | July 8, 2022 |
Last Update Posted: | January 13, 2023 |