A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.

  • STATUS
    Recruiting
  • End date
    Feb 15, 2024
  • participants needed
    80
  • sponsor
    AstraZeneca
Updated on 24 July 2021
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (3.5 mi away) Contact
+42 other location

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).

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 tissue metastasis (per Response Evaluation Criteria in Solid Tumours [RECIST v1.1]) or bone-only metastasis (per Prostate Cancer Working Group 3 [PCWG3 criteria]). There will be no formal comparisons between treatment arms.

AZD4635 plus durvalumab (Arm A) will consist of 80 participants with mCRPC previously treated with one or more approved new hormonal agent(s) (NHAs) and one or more taxanes or participants who are taxane ineligible.

AZD4635 plus durvalumab plus cabazitaxel (Arm B) will consist of 80 participants mCRPC previously treated with docetaxel and one prior NHA.

As of November 2020, the Sponsor stopped enrolment in Arm A following decisions at the program level, not related to any safety issues. Ongoing participants in Arm A may continue treatment as planned.

Details
Condition Progressive Metastatic Castrate-Resistant Prostate Cancer, Progressive Metastatic Castrate-Resistant Prostate Cancer, Progressive Metastatic Castrate-Resistant Prostate Cancer, Progressive Metastatic Castrate-Resistant Prostate Cancer, Progressive Metastatic Castrate-Resistant Prostate Cancer, Progressive Metastatic Castrate-Resistant Prostate Cancer, Progressive Metastatic Castrate-Resistant Prostate Cancer, Progressive Metastatic Castrate-Resistant Prostate Cancer, Progressive Metastatic Castrate-Resistant Prostate Cancer, Progressive Metastatic Castrate-Resistant Prostate Cancer, Progressive Metastatic Castrate-Resistant Prostate Cancer, Progressive Metastatic Castrate-Resistant Prostate Cancer, Progressive Metastatic Castrate-Resistant Prostate Cancer, Progressive Metastatic Castrate-Resistant Prostate Cancer, Progressive Metastatic Castrate-Resistant Prostate Cancer
Treatment durvalumab, Cabazitaxel, AZD4635
Clinical Study IdentifierNCT04495179
SponsorAstraZeneca
Last Modified on24 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Alanine aminotransferase (ALT) 2.5 upper limit of normal (ULN) if no demonstrable liver metastases or 5 ULN in the presence of liver metastases
Adequate organ function for Arm A as demonstrated by all of the following laboratory
values
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
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
TBL 2.0 ULN in the case of known Gilbert syndrome with normal direct bilirubin
Prior therapy with one or more lines of taxanes (eg, docetaxel and/or cabazitaxel)
Participants in Arm A must have received the following prior therapy
Alternatively, must be taxane-ineligible
AST and/or ALT 1.5 ULN
TBL ULN
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
Prior docetaxel (taxane) in either hormone-sensitive or hormone-refractory settings
values
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
TBL 2.0 ULN in the case of known Gilbert syndrome with normal direct bilirubin
Participants who meet inclusion criteria for Arm B will be allocated preferentially to that arm until recruitment to that arm is completed
Participants in Arm B must have received the following prior therapy

Exclusion Criteria

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
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
Creatinine clearance <40 mL/min (calculated by Cockcroft-Gault equation)
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