Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
A Study to Investigate the Biological Effects of Saruparib (AZD5305) Alone, Darolutamide Alone, and in Combination Given Prior to Radical Prostatectomy in Men with Newly Diagnosed Prostate Cancer (ASCERTAIN).
Full description
An Open-label, Randomised, Phase-I, Multi-Centre Study to Investigate the Biological Effects of Saruparib (AZD5305) alone, Darolutamide alone, and in Combination Given Prior to Radical Prostatectomy in Men with Newly Diagnosed Prostate Cancer (ASCERTAIN).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including, active bleeding diatheses, or active infection including HepB, hepatitis C and HIV. Screening for chronic conditions is not required.
Participants with any known predisposition to bleeding (eg, active peptic ulceration, recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy).
Participants with history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). In case there is no Clinical MDS/AML suspicion, no specific screening for MDS/AML (by bone marrow/bone biopsy) is required.
Prior malignancy within 3 years of screening whose natural history, in the Investigator's opinion, has the potential to interfere with safety and efficacy assessments of the investigational regimen.
Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of TdP.
Any of the following cardiac criteria:
Other CVS diseases as defined by any of the following:
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of Saruparib (AZD5305).
History of prior malignancy, treated with chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, or other anticancer agent within 3 years of screening. Previously localised surgically treated malignancy is acceptable, if no evidence of recurrence.
Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
Prior treatment with any systemic or localised anti-cancer treatment for the localised prostate cancer.
During the 4 weeks prior to the first dose, receiving immune modulatory agents including but not limited to, continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent.
Concomitant use of medications or herbal supplements known to be:
Treatment with any investigational agents or study interventions from a previous clinical study within 5 half-lives or 3 weeks (whichever is longer) of the first dose of study treatment.
Participants with contraindication to darolutamide for treatment arms
Unable to comply with the visits and assessments.
In the opinion of the Investigators should not be included in this study.
No treatment arm only: if any participant meets exclusion 4, 9 or 11, they are not to be included in the study.
Primary purpose
Allocation
Interventional model
Masking
120 participants in 4 patient groups
Loading...
Central trial contact
AstraZeneca Clinical Study Information Center
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal