A Phase 1 interventional study of BN83495 (Cohort 1) and BN83495 (Cohort 2) in Prostate Cancer, sponsored by Ipsen. Completed at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-15.
Sponsored by Ipsen · Phase 1, Interventional, and Treatment
The purpose of the study is to evaluate the pharmacodynamic profile and safety of BN83495 in patients with prostate cancer with disease progression while on androgen ablative therapy
Evaluate the PD profile of BN83495 after 28 days of daily oral administration in patients with locally advanced or metastatic prostate cancer on androgen ablative therapy and with rising prostatic specific antigen
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 17 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
6 patients have been enrolled, the cohort has been completed.
Drug: BN83495 (Cohort 1)
6 patients have been enrolled in cohort 2, the cohort has been completed.
Drug: BN83495 (Cohort 2)
5 patients have been enrolled in cohort 3. The cohort was closed after the 5th patient enrolled.
Drug: BN83495 (Cohort 3)
20 mg daily BN83495 for 28 days
40 mg daily BN83495 for 28 days
60 mg daily BN83495 for 28 days
Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints
Time frame: 28 days
Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression)
Time frame: Each visit through day 28/29
Pharmacokinetic assessments/Pharmacodynamic assessments
Time frame: Pre-determined timepoints from baseline to day 28/29
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Ipsen