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Antarelix

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Hormone Antagonists

Participants receive teverelix TFA loading dose on Day 0 (120 mg SC + 120 mg IM) and teverelix TFA maintenance doses of 120 mg SC at week 6 and 6-weekly thereafter up to week 24

Participants receive teverelix TFA loading dose on Day 0 (180 mg SC + 180 mg IM) and teverelix TFA maintenance doses of 180 mg SC at week 6 and 6-weekly thereafter up to week 24

Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24

teverelix TFA 120 mg

Teverelix TFA 360 mg Day 0 and 180 mg every 6 weeks from week 6 to week 24

teverelix TFA 180 mg

Albertas Ulys, MD

The purpose of this study is to assess the safety and efficacy of teverelix TFA in the treatment of advanced prostate cancer

After being informed about the study and potential risks, all patients giving written informed consent will undergo an up to 7 day screening period to determine eligibility for study entry. On Day 0, patients who meet the eligibility requirements will be enrolled in an open-label manner and will receive a loading dose of teverelix TFA (one subcutaneous (SC) injection in the abdomen and one intramuscular (IM) injection in the buttock). Patients will then receive maintenance doses of teverelix TFA (one SC injection in the abdomen) at 4- or 6-weekly intervals up to week 24. The patients will return for a final assessment 4 weeks after their last maintenance dose injection.

The initial dosing regimen to be tested (Group 1) is:

Loading Dose = 120 mg teverelix TFA SC + 120 mg teverelix TFA IM Maintenance Dose = 120 mg teverelix TFA SC every 6 weeks

If this dosing regimen is unsuccessful (more than 2 (of 20) patients fail treatment) then recruitment to Group 1 will end and enrollment in Group 2 will open.

The dosing regimen that may be tested (Group 2) is:

Loading Dose = 180 mg teverelix TFA SC + 180 mg teverelix TFA IM Maintenance Dose = 180 mg teverelix TFA SC every 6 weeks

If this dosing regimen is unsuccessful (more than 6 (of 60) patients fail treatment) then recruitment to Group 2 will end and the study will be terminated.

Adaptive design - enrollment will open in Group 1 (6-weekly dosing regimen). Only if Group 1 dosing regimen is unsuccessful will enrollment open in Group 2 (4-weekly dosing regimen)

Teverelix Evaluated in Advanced Prostate Cancer

An Adaptive Phase 2, Open-Label, Multicentre Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix Trifluoroacetate, a GnRH Antagonist, in Participants With Advanced Prostate Cancer

Proportion of participants achieving castration level with serum T \<0.5 ng/mL at Day 28.

Proportion of participants achieving castration level with serum T \<0.2 ng/mL at Day 28

Proportion of participants achieving castration level with serum T \<0.5 ng/mL at Day 42

Proportion of participants achieving profound castration level (0.2 ng/mL) with serum T \<0.5 ng/mL at Day 42

Proportion of participants achieving a T castration rate over 168 days of treatment period

Proportion of participants achieving profound castration rate (\<0.2 ng/mL) over 168 days of treatment period

Mean time to T levels falling below castration level (\<0.5 ng/mL) for the first time

Mean time to (first) overstep of T castration level after achieving castration

Proportion of participants achieving castration level for LH (LH \<1.1 U/L) at Day 28

Proportion of participants with effective LH castration rate over 168 days of treatment period

Mean time to LH levels falling below castration level (LH \<1.1 U/L) for the first time

Mean time to (first) overstep of LH castration level after achieving castration

Area under the concentration time-curve from time zero up to the last quantifiable concentration at time point t (Ct), calculated using the linear up/log down trapezoidal rule.

Area under the concentration time-curve from time zero up to the concentration at time point t1 after which the concentrations start to rise again towards a second peak, calculated using the linear up/log down trapezoidal rule. t1 will be determined after review of the concentration-time profiles (immediate release component of total observed AUC).

Maximum observed concentration after administration

Maximum observed concentration after administration from zero up to time point t1

Maximum observed concentration after administration from time point t1 up to time point t

Time of the last quantifiable concentration

Apparent terminal elimination rate constant

Apparent terminal plasma half-life, calculated as: ln 2 / lambda-z

Area under the concentration time-curve from time zero up to infinity (∞),calculated using the linear up/log down trapezoidal rule.

Number of participants with a PSA response of ≥50 percent reduction at the Day 168 visit

Number of participants with a PSA response of ≥120 percent reduction at the Day 168 visit

Percent change from baseline in serum PSA concentration at each visit

Mean serum PSA concentration at each visit

Mean serum LH concentration at each visit

Mean serum FSH concentration at each visit

Number of participants with treatment-emergent AEs

Mean changes in vital signs at each visit during the 168-day treatment period, compared to baseline

Incidence of abnormal laboratory tests results

Percentage of participants with ISRs at each visit during the 168 days treatment period

Spots Global Cancer Trial Database for teverelix tfa 180 mg