Status:
COMPLETED
A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Progressive Metastatic Castrate-Resistant Prostate Cancer
Eligibility:
MALE
18-150 years
Phase:
PHASE2
Brief Summary
This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with metastatic castration-resistant prostate cancer (mCRPC).
Detailed Description
This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with mCRPC. Participants in each arm will be stratified by the presence of measurable soft tissu...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate.
- Known castrate-resistant disease.
- Evidence of disease progression ≤6 months.
- Body weight \>30 kg at screening.
- Willingness to adhere to the study treatment-specific contraception requirements.
- Adequate bone marrow reserve and organ function.
- Adequate organ function for Arm A as demonstrated by all of the following laboratory values:
- Alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤5 × ULN in the presence of liver metastases.
- Aspartate aminotransferase (AST) ≤2.5 × ULN if no demonstrable liver metastases or ≤5 × ULN in the presence of liver metastases
- Total bilirubin (TBL) ≤1.5 × ULN
- TBL ≤2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin
- Participants in Arm A must have received the following prior therapy:
- Maximum of 3 lines of therapy in the mCRPC setting
- Prior therapy with one or more NHAs (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide) in either hormone-sensitive or hormone-refractory settings
- Prior therapy with one or more lines of taxanes (eg, docetaxel and/or cabazitaxel)
- Alternatively, must be taxane-ineligible
- Prior therapy can be in either the hormone-sensitive or the hormone-refractory setting
- Adequate organ function for Arm B as demonstrated by all of the following laboratory values:
- AST and/or ALT ≤1.5 × ULN
- TBL ≤ ULN
- TBL ≤2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin
- Participants in Arm B must have received the following prior therapy:
- Prior docetaxel (taxane) in either hormone-sensitive or hormone-refractory settings
- Received no prior cytotoxic chemotherapy other than docetaxel for prostate cancer except for estramustine and except adjuvant/neo-adjuvant treatment completed \>3 years ago.
- Prior therapy with only one NHAs (eg, abiraterone acetate or enzalutamide; prior apalutamide is not permitted) for treatment of mCRPC in either hormone-sensitive or hormone-refractory settings.
- Be suitable to receive concomitant Granulocyte-colony stimulating factor during all cycles of cabazitaxel.
- Participants who meet inclusion criteria for Arm B will be allocated preferentially to that arm until recruitment to that arm is completed.
Exclusion
- Active brain metastases or leptomeningeal metastases.
- There must be no requirement for immunosuppressive doses of systemic corticosteroids for at least 2 weeks prior to study enrollment.
- History of pneumonitis requiring corticosteroids, second malignancy that is progressing and/or received active treatment ≤3 years before the first dose of study intervention, and hypersensitivity to polysorbate-80 if allocated to cabazitaxel.
- As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases.
- Creatinine clearance \<40 mL/min (calculated by Cockcroft-Gault equation).
- Prior exposure to immune-mediated therapy including.
- Ongoing treatment with warfarin (Coumadin).
- Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study intervention.
Key Trial Info
Start Date :
August 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04495179
Start Date
August 4 2020
End Date
August 8 2022
Last Update
August 9 2023
Active Locations (16)
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1
Research Site
Sacramento, California, United States, 95817
2
Research Site
Tampa, Florida, United States, 33612
3
Research Site
Atlanta, Georgia, United States, 30318
4
Research Site
St Louis, Missouri, United States, 63110