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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521873-15-00 | Registry Identifier | EU CT Number |
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The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).
The study consists of two phases:
Phase I:
The Phase I part includes two groups: Part 1 will assess the combination of tulmimetostat with darolutamide (Group A), and Part 2 will assess tulmimetostat with abiraterone (Group B). The primary objective of Phase I is to determine the recommended dose escalations (RDEs) for each combination, with enrollment using a staggered approach between groups.
Participants in both groups will continue androgen deprivation therapy (ADT) to maintain castrate testosterone levels (<50 ng/dL or <1.7 nmol/L), as determined by the investigator based on local guidelines. In Group B, abiraterone will be administered with an oral corticosteroid (prednisone or prednisolone) per local prescribing information.
Phase II:
Phase II is a randomized, open-label, multicenter dose-expansion study to further evaluate the recommended dose(s) of tulmimetostat in combination with darolutamide and provide proof-of-concept for efficacy and safety. Participants will be randomized to receive tulmimetostat plus darolutamide or darolutamide alone.
Eligible participants include those with metastatic hormone-sensitive prostate cancer (mHSPC) who are either de novo or recurrent, without prior radioligand therapy, but who may have received prior taxane-based chemotherapy and/or androgen receptor pathway inhibitors (ARPIs), excluding darolutamide. The study evaluates tulmimetostat-based combinations as potential treatment options for men with mHSPC.
The study for each participant consists of a screening period, a study treatment period followed by a post treatment long-term follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: Group A (part 1) | Experimental | Tulmimetostat oral (PO) once a day (QD) escalating doses + Darolutamide 600 mg twice a day (BID) |
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| Phase I: Group B (part 2) | Experimental | Tulmimetostat PO QD escalating doses + Abiraterone 1000 mg PO QD |
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| Phase II: Arm 1 | Experimental | Tulmimetostat dose 1 PO + Darolutamide 600 mg PO BID |
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| Phase II: Arm 2 | Experimental | Tulmimetostat dose 2 PO + Darolutamide 600 mg PO BID |
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| Phase II: Arm 3 | Active Comparator | Darolutamide 600 mg PO BID |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tulmimetostat | Drug | Doses of tulmimetostat beyond DL1 once a day (QD) will be opened depending on outcome of Dose Escalation Meetings (DEM(s)) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I (Group A and Group B): Dose-limiting toxicities (DLTs) | A dose-limiting toxicity is defined as an adverse event or abnormal laboratory value, not clearly due to underlying disease or extraneous causes, that occurs within the first 28 days of treatment with tulmimetostat and meets any of the criteria specified in the protocol. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for all grading. For the purpose of dose-escalation decisions, DLTs will be considered and included in the Bayesian Logistic Regression Model (BLRM). | Up to 28 days |
| Phase I (Group A and Group B): Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) | The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0. | From date of randomization till 30 days safety fup, assessed up to approximately 79 months |
| Phase I (Group A and Group B): Number of Participants with dose adjustments | The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm. | From date of randomization till 30 days safety fup, assessed up to approximately 79 months |
| Phase I (Group A and Group B): Dose Intensity | Dose intensity (computed as the ratio of actual cumulative dose received and actual duration of exposure) and the relative dose intensity (computed as the ratio of dose intensity and planned dose intensity) will be summarized by means of descriptive statistics | From date of randomization till 30 days safety fup, assessed up to approximately 79 months |
| Phase I (Group A and Group B): Duration of exposure to each study drug | Duration of exposure (in months) to each study drug will be summarized by means of descriptive statistics |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I (Group A): Plasma concentrations of Tulmimetostat and Darolutamide | Tulmimetostat and Darolutamide pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels by treatment arms | Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days. |
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Key Inclusion Criteria:
Adult men ≥ 18 years old with de novo or recurrent mHSPC (without neuroendocrine or small cell features). The tumor lesion(s) may be located in the bone, soft tissue/visceral region, or both.
Participants must have castrate levels of testosterone, i.e., ≤ 50 ng/dL (≤ 1.7 nM).
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Adequate bone marrow and organ function
Prior ADT: Participants must have started ADT at least 1 month (at least 28 days) but no more than 12 months before study entry and be willing to continue ADT during treatment
Prior taxane use for mHSPC is permitted:
~ Phase I and II: Participants may have received, but not progressed on, one prior taxane-based therapy. Phase II: Limited to 25% participants with prior taxane use.
Prior ARPI is allowed in both Phase I and Phase II:
Prior ARPI use in biochemical recurrence (BCR) or curative treatment is allowed for any duration, provided therapy was discontinued and participant had no evidence of conventional imaging positive metastatic disease at that time
Prior ARPI use in mHSPC is permitted but not mandated. - If participants meet all study eligibility criteria, they are required to stop their prior ARPI after providing informed consent and remain off ARPI until Cycle 1 Day 1, when study treatment is initiated.
Other permitted prior local therapy for mHSPC:
Key Exclusion Criteria:
Participants with evidence of mCRPC or biochemical recurrence / PSA only disease or asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy and with normal PSA for ≥ 1 year prior to the start of study treatment.
Participants who have not received ARPI treatment for mHSPC and present with PSA levels of ≤0.5 ng/mL or those with prior/ongoing ARPI treatment presenting with PSA levels of ≤ 0.2 ng/mL prior to treatment assignment/randomization.
Participants with CNS metastases are excluded unless:
Concurrent use of first-generation anti-androgens (like bicalutamide). Prior use of a first-generation anti-androgen drug in the context of ADT initiation with a GNRH analog is allowed, provided it was administered for ≤14 days and the last dose was administered ≥7 days from the study entry.
Systemic ketoconazole is used as antineoplastic treatment for prostate cancer.
Previous exposure to radioligand therapy.
Treatment with any investigational agent within 28 days (or 5 half-lives, whichever is longer) prior to study entry.
Previous treatment with any Polycomb Repressive Complex 2 (PRC2) inhibitor, including but not limited to Enhancer of Zeste Homolog 2 (EZH2) inhibitors, EZH2/1 inhibitors, or embryonic ectoderm development (EED) inhibitors.
Herbal products that may decrease PSA levels within 4 weeks prior to the start of study drug treatment and while on study.
Participants taking prohibited medication(s) (e.g., strong CYP3A4 inducers or strong or moderate CYP3A4 inhibitors that cannot be stopped within 7 days or 5 half-lives (whichever is longer) prior to study treatment and for the duration of the study treatment or prohibited herbal product(s) that cannot be stopped 7 days prior to study treatment.
Other inclusion/exclusion criteria may apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | 1-888-669-6682 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294-3300 | United States |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Phase I (Part 1 and Part 2) = Open-label Phase II = Randomized
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| Darolutamide | Drug | 600 mg is administered orally BID |
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| Abiraterone | Drug | 1000 mg is administered orally QD |
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| From date of randomization till 30 days safety fup, assessed up to approximately 79 months |
| Phase II (Group A): Prostate-Specific Antigen (PSA) response rate of < 0.2 ng/mL | Prostate-Specific Antigen (PSA) response rate is defined as proportion of participants who achieved a decline in PSA to < 0.2 ng/mL at month 6 months, confirmed by a second PSA measurement ≥ 3 weeks later. | From date of randomization till 30 days safety fup, assessed up to approximately 79 months |
| Phase I (Group A): AUC of Tulmimetostat and Darolutamide | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast), Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) and Area under the concentration-time curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) will be listed and summarized using descriptive statistics. | Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days. |
| Phase I (Group A): Cmax of Tulmimetostat and Darolutamide | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics. | Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days. |
| Phase I (Group B): Plasma concentrations of Tulmimetostat and Abiraterone | Tulmimetostat and Abiraterone pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels by treatment arms | Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Day 2 (0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days. |
| Phase I (Group B): AUC of Tulmimetostat and Abiraterone | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast), Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) and Area under the concentration-time curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) will be listed and summarized using descriptive statistics. | Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Day 2 (0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days. |
| Phase I (Group B): Cmax of Tulmimetostat and Abiraterone | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics. | Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Day 2 (0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days. |
| Phase II (Group A): Radiographic progression free survival (rPFS) | Radiographic progression free survival (rPFS) is defined as the time between randomization and the first occurrence of disease progression as per PCWG3-modified RECIST v1.1 or death due to any cause | From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 79 months |
| Phase II (Group A):Overall survival (OS) | Overall survival (OS) is defined as the time between randomization to date of death due to any cause | From date of randomization until date of death from any cause, assessed up to approximately 79 months |
| Phase II (Group A): Objective response (OR) | Objective response (OR) is defined as a confirmed Complete Response (CR) or Partial Response (PR) per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST 1.1 as assessed by the Investigator | From date of randomization until date of confirmed Complete Response (CR) or Partial Response (PR), assessed up to approximately 79 months |
| Phase II (Group A): Best Overall response (BOR) | Best Overall response (BOR) is defined as the best response per PCWG3-modified RECIST 1.1 as assessed by the Investigator from the start of the treatment until disease progression/recurrence | From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 79 months |
| Phase II (Group A): Duration of response (DOR) | Duration of response (DOR) defined as time between first documented CR/PR and disease progression per PCWG3-modified RECIST 1.1 as assessed by the Investigator or death due to any cause | From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 79 months |
| Phase II (Group A): Prostate-Specific Antigen 50 (PSA50) | Prostate-Specific Antigen 50 (PSA50) is defined as a ≥ 50% decrease in PSA levels from baseline at any timepoint, confirmed by a second PSA measurement ≥ 3 weeks without any PSA progression in between | From date of randomization till 30 days safety fup, assessed up to approximately 79 months |
| Phase II (Group A): Prostate-Specific Antigen (PSA) Response of <0.1 ng/mL | Prostate-Specific Antigen (PSA) Response of <0.1 ng/mL is defined as PSA level < 0.1 ng/mL at any timepoint during the trial from randomization | From date of randomization till 30 days safety fup, assessed up to approximately 79 months |
| Phase II (Group A): Time to castration-resistant prostate cancer (CRPC) | Time to castration-resistant prostate cancer (CRPC) is defined as the time from randomization to the first occurrence of one of the following events: PSA progression, radiological progression by bone lesions, or radiological progression by soft tissue and visceral lesions | From date of randomization until date of PSA progression, radiological progression by bone lesions, or radiological progression by soft tissue and visceral lesions, whichever comes first, assessed up to approximately 79 months |
| Phase II (Group A): Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) | The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0. | From date of randomization till 30 days safety fup, assessed up to approximately 79 months |
| Phase II (Group A): Number of Participants with dose adjustments | The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm. | From date of randomization till 30 days safety fup, assessed up to approximately 79 months |
| Phase II (Group A): Dose Intensity | Dose intensity (computed as the ratio of actual cumulative dose received and actual duration of exposure) and the relative dose intensity (computed as the ratio of dose intensity and planned dose intensity) will be summarized by means of descriptive statistics | From date of randomization till 30 days safety fup, assessed up to approximately 79 months |
| Phase II (Group A): Duration of exposure to each study drug | Duration of exposure to each study drug will be summarized by means of descriptive statistics | From date of randomization till 30 days safety fup, assessed up to approximately 79 months |
| Phase II (Group A): Plasma concentrations of Tulmimetostat and Darolutamide | In selected number of participants receiving Tulmimetostat and Darolutamide combination therapy in Phase II, or in selected number of participants if only one dose level of Tulmimetostat is evaluated in combination with Darolutamide in Phase II, Tulmimetostat and Darolutamide pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels by treatment arms | Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days. |
| Phase II (Group A): AUC of Tulmimetostat and Darolutamide | In selected number of participants receiving tulmimetostat and darolutamide combination therapy in Phase II, or in selected number of participants if only one dose level of tulmimetostat is evaluated in combination with darolutamide in Phase II, venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast), Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) and Area under the concentration-time curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) will be listed and summarized using descriptive statistics. | Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days. |
| Phase II (Group A): Cmax of Tulmimetostat and Darolutamide | In selected number of participants receiving tulmimetostat and darolutamide combination therapy in Phase II, or in selected number of participants if only one dose level of tulmimetostat is evaluated in combination with darolutamide in Phase II, venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics. | Cycle 1-2: Day 1 (0 hour, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours). Cycle 1: Day 2 (Tulmimetostat only: 0 hour and 24 hours), Days 8 and 15 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days. |
| Phase II (Group A): Plasma concentrations of Tulmimetostat | Tulmimetostat pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels by treatment arms | Cycle 1-2: Day 1 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days. |
| Phase II (Group A): AUC of Tulmimetostat | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast), Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) and Area under the concentration-time curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) will be listed and summarized using descriptive statistics. | Cycle 1-2: Day 1 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days. |
| Phase II (Group A): Cmax of Tulmimetostat | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics. | Cycle 1-2: Day 1 (0 hour and 2 hours). Cycles 3-5: Day 1 (0 hour). 1 cycle = 28 days. |
| Phase II (Group A): Time to first symptomatic skeletal event (TTSSE) | Time to first symptomatic skeletal event (TTSSE) is defined as the time from randomization to the first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first | From randomization until the first occurrence of a new symptomatic bone fracture, spinal cord compression, tumor-related orthopedic surgery, radiation therapy for bone pain, or death, assessed up to 79 months. |
| Uni Of Iowa Hospitals And Clinics | Recruiting | Iowa City | Iowa | 52242 | United States |
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| University of Kansas Cancer Center | Recruiting | Westwood | Kansas | 66205 | United States |
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| Wichita Urology Group PA | Recruiting | Wichita | Kansas | 67226 | United States |
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| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| Medical University of South Carolina MUSC | Recruiting | Charleston | South Carolina | 29425 | United States |
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| Carolina Urologic Research Center | Recruiting | Myrtle Beach | South Carolina | 29572 | United States |
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| Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
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| Novartis Investigative Site | Withdrawn | Camperdown | New South Wales | 2050 | Australia |
| Novartis Investigative Site | Recruiting | Wollongong | New South Wales | 2500 | Australia |
| Novartis Investigative Site | Recruiting | Porto Alegre | Rio Grande do Sul | 90610-001 | Brazil |
| Novartis Investigative Site | Recruiting | Montreal | Quebec | H2X 1R9 | Canada |
| Novartis Investigative Site | Recruiting | Guangzhou | 510060 | China |
| Novartis Investigative Site | Recruiting | Créteil | 94010 | France |
| Novartis Investigative Site | Recruiting | Lille | 59020 | France |
| Novartis Investigative Site | Recruiting | Nantes | 44093 | France |
| Novartis Investigative Site | Recruiting | Jena | Thuringia | 07740 | Germany |
| Novartis Investigative Site | Recruiting | Essen | 45147 | Germany |
| Novartis Investigative Site | Recruiting | Hong Kong | 999077 | Hong Kong |
| Novartis Investigative Site | Recruiting | Budapest | H 1122 | Hungary |
| Novartis Investigative Site | Recruiting | Budapest | H-1083 | Hungary |
| Novartis Investigative Site | Recruiting | Szeged | 6725 | Hungary |
| Novartis Investigative Site | Recruiting | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Recruiting | Verona | VR | 37134 | Italy |
| Novartis Investigative Site | Recruiting | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 06591 | South Korea |
| Novartis Investigative Site | Recruiting | Madrid | 28034 | Spain |
| Novartis Investigative Site | Recruiting | Madrid | 28040 | Spain |
| Novartis Investigative Site | Recruiting | Madrid | 28222 | Spain |
| Novartis Investigative Site | Recruiting | Ankara | Sihhiye-Altindag | 06230 | Turkey (Türkiye) |
| Novartis Investigative Site | Recruiting | London | W1G 6AD | United Kingdom |
| ID | Term |
|---|---|
| D055534 | Bulbo-Spinal Atrophy, X-Linked |
| ID | Term |
|---|---|
| D009134 | Muscular Atrophy, Spinal |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D016472 | Motor Neuron Disease |
| D009468 | Neuromuscular Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C000607739 | darolutamide |
| C089740 | abiraterone |
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