EUCTR2020-000209-10-DE
Active, not recruiting
Phase 1
A Phase II, Open-label Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination with Durvalumab and in Combination with Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC) - AARDVARC
ConditionsProgressive Metastatic Castrate-Resistant Prostate CancerMedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsJevtana
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Progressive Metastatic Castrate-Resistant Prostate Cancer
- Sponsor
- AstraZeneca AB
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Participant must be 18 years of age inclusive at the time of signing the
- •informed consent.
- •2 Histologically confirmed adenocarcinoma of the prostate.
- •3 Known castrate\-resistant disease.
- •4 Evidence of disease progression \=6 months.
- •5 Body weight \>30 kg at screening.
- •6 Willingness to adhere to the study treatment\-specific contraception
- •requirements.
- •7 Adequate bone marrow reserve and organ function.
- •8 Adequate organ function for Arm A as demonstrated by all of the
Exclusion Criteria
- •1 Active brain metastases or leptomeningeal metastases.
- •2 There must be no requirement for immunosuppressive doses of
- •systemic corticosteroids for at least 2 weeks prior to study enrollment.
- •3 History of pneumonitis, 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.
- •4 As judged by the Investigator, any evidence of severe or uncontrolled
- •systemic diseases.
- •5 Creatinine clearance \<40 mL/min (calculated by Cockcroft\-Gault
Outcomes
Primary Outcomes
Not specified
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