TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer (NCT04887506) | Clinical Trial Compass
CompletedPhase 3
TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer
United States107 participantsStarted 2021-05-05
Plain-language summary
The purpose of this study is to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Written informed consent obtained prior to any study-related procedure being performed
✓. Male patients at least 18 years of age or older at time of consent
✓. Pathologically confirmed adenocarcinoma of the prostate
✓. Ongoing therapy with a gonadotropin releasing hormone (GnRH) agonist or antagonist (unless patient has already had a bilateral orchiectomy) AND serum testosterone level \<50 ng/dL at screening
✓. Have either metastatic CSPC or metastatic CRPC (per protocol definitions).
✓. The following prior treatments and/or surgery for prostate cancer are allowed:
✓. CSPC:
✓. CRPC:
Exclusion criteria
✕. For mCSPC patients: any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer not specified as allowable treatment in Inclusion Criterion 6. For example, prior therapy with apalutamide or enzalutamide is prohibited as well as therapy with an investigational agent as described in Exclusion Criterion 16.
✕. For mCRPC patients:
✕. Initiation of bisphosphonate or denosumab therapy within 4 weeks prior to the start of study drug/reference product. Patients who are on a stable dose of these medications for at least 4 weeks at the time of starting study drug/reference product will be eligible.
What they're measuring
1
Serum Testosterone (ng/dL) Days 9 and 10 Average (Rounded-up), CR-ITT
. Therapy with estrogen within 4 weeks prior to the start of study drug
✕. Use of systemic glucocorticoids equivalent to \>10 mg prednisone daily. Patients who have discontinued or reduced dosing to the equivalent of ≤ 10 mg prednisone daily within 14 days prior to the start of study drug are eligible
✕. Known, symptomatic metastases to the brain or central nervous system involvement (patients with asymptomatic and neurologically stable disease for the past 4 weeks will be permitted)
✕. History of adrenal gland dysfunction defined as requiring treatment for adrenal insufficiency
✕. History of other malignancy within the previous 2 years (no longer being actively treated), with the exceptions of basal cell carcinoma, nonmuscle invasive bladder cancer that has been treated and is under surveillance, or other in-situ cancers with a low likelihood of recurrence