Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]-TAK-385 Oral Solution, Relugolix
TAK-385 · 7 trials · 4 indications
Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. The percentage of participants with a score of 1 or less is reported.
PBAC score was used to measure volume of menstrual blood loss. Participants used sanitary products designated by sponsor and recorded the numbers of tampons or towels used, clots and flooding in patient diary. Three diagrams used which represented a lightly, moderately stained or completely saturated pad/tampon. Following scores assigned: 1) 1, 5, or 20 points for each pad; 2) 1, 5, or 10 points for each tampon; 3) 1 or 5 points for each blood clot of \<1 cm/=1 cm/\>1 in longest diameter; 4) 5 points for each episode of flooding. The total PBAC score (sum of points) ranges from 0 to \>500.
Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (\<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter \[nmol/L\]) at all scheduled visits.
Measured by Dual-energy X-ray absorptiometry (DXA)
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit (Week 16)
Vital signs will include body temperature, sitting blood pressure and pulse (bpm).
NTx is one of the biochemical bone metabolism markers
BAP is one of the biochemical bone metabolism markers
Blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC).
Pelvic pain will be assessed using the VAS as pain evaluation scale.
DLTs were defined as treatment-related adverse events (AEs) that occurred within the first 28 days of treatment as per common terminology criteria for adverse events (CTCAE) version 4.03: any grade 3 or higher toxicity; QT/Fridericia corrected QT (QTcF) greater than (\>) 500 millisecond (msec) after treatment initiation; QT/QTcF interval prolongation \>60 msec postdose.
Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activity of daily living (ADL); Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities.
Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL; Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities. Here aspartate aminotransferase (AST) (glutamic-oxaloacetic transaminase \[GOT\]) High, creatine kinase (CK) (creatine phosphokinase \[CPK\]) High, prothrombin time (PT)-international normalized ratio (INR) High.
Here "BP" is blood pressure.
| Arm | Type | Description |
|---|---|---|
| Relugolix 40 mg | EXPERIMENTAL | Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix 40 mg, tablet, orally once daily before breakfast for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Relugolix placebo-matching tablet, orally, once daily before breakfast for 3 to 6 weeks in the run-in period, followed by relugolix placebo-matching tablet, orally once daily before breakfast for 12 weeks. |
| Leuprorelin 1.88 mg or 3.75 mg | ACTIVE_COMPARATOR | Relugolix placebo matching tablets, orally, once daily along with leuprorelin acetate placebo matching injection, SC, once in 4 weeks for 3 to 6 weeks in run-in period followed by leuprorelin acetate 1.88 mg or 3.75 mg, injection, SC, once in 4 weeks and relugolix placebo matching tablets, orally, once daily for 24 weeks in treatment period. |
| TAK-385 | EXPERIMENTAL | TAK-385 320 mg, tablets, orally, once, on Day 1, followed by TAK-385 120 mg, orally, once daily for 24 weeks. Each participant may have one upward dose adjustment of 40 mg for efficacy and/or one downward dose adjustment of 40 mg for safety during the study. |
| Degarelix | ACTIVE_COMPARATOR | Degarelix 240 mg, injection, subcutaneous, on Day 1, followed by degarelix 80 mg, injection, subcutaneous, once every four weeks, for 24 weeks. |
| TAK-385 10 mg QD | EXPERIMENTAL | - |
| TAK-385 20 mg QD | EXPERIMENTAL | - |
| TAK-385 40 mg QD | EXPERIMENTAL | - |
| Leuplin | OTHER | - |
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | EXPERIMENTAL | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
| Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | EXPERIMENTAL | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
| Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | EXPERIMENTAL | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
| Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | EXPERIMENTAL | TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
| Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg | EXPERIMENTAL | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. |
| Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg | EXPERIMENTAL | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. |
| Name | Type | Description |
|---|---|---|
| Relugolix | DRUG | Relugolix Tablets |
| Relugolix placebo | DRUG | Relugolix placebo-matching tablets |
| Leuprorelin | DRUG | Leuprorelin injection |
| Leuprorelin Placebo | DRUG | Leuprorelin placebo-matching injections |
| TAK-385 | DRUG | TAK-385 tablet |
| Degarelix | DRUG | Degarelix injection |
| Placebo | DRUG | TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks. |
| Leuprorelin acetate | DRUG | TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks |
Inclusion Criteria: Inclusion Criteria for Entering the Screening Period (at VISIT 1) 1. In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant signs and dates a written, informed consent form ...
TAK-385 is an investigational small molecule developed by Takeda Pharmaceutical Company Limited. It has been studied in Phase 2 clinical trials for endometriosis, uterine fibroids, and prostate cancer, including hormone treatment-naive participants with prostate cancer. It is an oral therapy and has not been approved for any indication.
TAK-385 has been studied for the treatment of endometriosis, uterine fibroids, and prostate cancer, including hormone treatment-naive participants with prostate cancer. All clinical trials of TAK-385 have been completed, and the drug remains investigational. It is not approved for any of these indications.
TAK-385 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the clinical trials evaluating TAK-385 in endometriosis and prostate cancer. The drug is an investigational small molecule and has not been approved for commercial use.
TAK-385 is in Phase 2 development. Its clinical program includes Phase 2 trials in endometriosis and localized prostate cancer, plus a Phase 1 trial in hormone treatment-naive participants with prostate cancer. All trials have been completed, and TAK-385 is not FDA approved.
TAK-385 has been evaluated in completed trials including NCT01458301 and its long-term extension NCT01452685 in endometriosis, NCT02135445 in localized prostate cancer, and NCT02141659 in hormone treatment-naive prostate cancer. These trials enrolled a total of 884 participants across Japan, the United States, and the United Kingdom.
Yes, [14C]-TAK-385 Oral Solution and TAK-385 40 mg are alternative names for TAK-385, the investigational small molecule developed by Takeda Pharmaceutical Company Limited. These names refer to the same drug candidate studied in clinical trials for endometriosis, uterine fibroids, and prostate cancer.