Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT06190899
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
54 participants
INTERVENTIONAL
2024-01-01
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Phase 1 Dose Finding (2 Parts)
o Part 1: DLT evaluation and determination of tolerated doses
* Part 2: Determination of RP2D
* Phase 2 Dose Expansion
TREATMENT
NONE
Study Groups
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Phase 1 Arm 1
Arm 1 - 120 mg of gedatolisib (administered once weekly for 3 weeks on/1 week off) in combination with darolutamide 600 mg (two 300 mg tablets) orally administered twice daily (equivalent to a total daily dose of 1200 mg on Days 1-28 of each cycle)
Gedatolisib
Gedatolisib is a potent reversible inhibitor that selectively targets all Class I PI3K isoforms and mTOR.
Darolutamide
Darolutamide is a novel androgen receptor inhibitor that has been studied and received approval for treatment of patients with nonmetastatic CRPC and in metastatic hormone-sensitive prostate cancer.
Phase 1 Arm 2
Arm 2 - 180 mg of gedatolisib (administered once weekly for 3 weeks on/1 week off) in combination with darolutamide 600 mg (two 300 mg tablets) orally administered twice daily (equivalent to a total daily dose of 1200 mg on Days 1-28 of each cycle)
Gedatolisib
Gedatolisib is a potent reversible inhibitor that selectively targets all Class I PI3K isoforms and mTOR.
Darolutamide
Darolutamide is a novel androgen receptor inhibitor that has been studied and received approval for treatment of patients with nonmetastatic CRPC and in metastatic hormone-sensitive prostate cancer.
Phase 2
The recommended Phase 2 dose (RP2D) of gedatolisib (administered once weekly for 3 weeks on/1 week off) in combination with darolutamide 600 mg (two 300 mg tablets) orally administered twice daily (equivalent to a total daily dose of 1200 mg on Days 1-28 of each cycle)
Gedatolisib
Gedatolisib is a potent reversible inhibitor that selectively targets all Class I PI3K isoforms and mTOR.
Darolutamide
Darolutamide is a novel androgen receptor inhibitor that has been studied and received approval for treatment of patients with nonmetastatic CRPC and in metastatic hormone-sensitive prostate cancer.
Interventions
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Gedatolisib
Gedatolisib is a potent reversible inhibitor that selectively targets all Class I PI3K isoforms and mTOR.
Darolutamide
Darolutamide is a novel androgen receptor inhibitor that has been studied and received approval for treatment of patients with nonmetastatic CRPC and in metastatic hormone-sensitive prostate cancer.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without a small cell component and with \<10% neuroendocrine type cells
3. Subjects must have metastatic castration-resistant prostate cancer (mCRPC; i.e., developed progression of metastases following surgical castration or during medical androgen ablation therapy)
4. Metastatic disease identified by conventional imaging: computed tomography (CT), magnetic resonance imaging (MRI), or technetium 99m-methyl diphosphonate (99mTc-MDP) bone scintigraphy. Measurable and non-measurable disease are allowed, but metastases visible only on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) will not be allowed for eligibility purposes.
5. Progressive mCRPC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with modifications as specified in Prostate Cancer Working Group 3 (PCWG3) criteria as defined by at least one of the following criteria:
5.1. Prostate-specific antigen (PSA) progression defined as a minimum of 2 rising PSA levels with a minimum of a 1-week interval between each determination. A minimum PSA of 1.0 ng/mL is required for study entry.
5.2. Soft-tissue progression defined as an increase ≥20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. 5.3. Progression of bone disease (measurable disease) or 2 or more new bone lesions by bone scan.
6. Continued primary androgen deprivation with luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist) if the subject has not undergone bilateral orchiectomy
7. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1
8. Progression during treatment with one next-generation androgen receptor signaling inhibitor for metastatic disease (e.g., abiraterone, enzalutamide, apalutamide, darolutamide)
9. Completion of prior treatment with an androgen receptor inhibitor (ARi) ≥4 weeks before the first dose of the study drug
10. At least 2 weeks beyond treatment with a targeted therapy or major surgery and at least 3 weeks beyond any other systemic anticancer therapy and/or radiation therapy, and resolution of all toxicities related to prior therapies or surgical procedures to baseline (except alopecia, Grade 1 peripheral neuropathy)
11. Adequate bone marrow, hepatic, renal and coagulation function
Exclusion Criteria
2. Adenocarcinoma of the prostate with a small cell component, and with ≥10% neuroendocrine type cells
3. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (AKT) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor
4. Prior treatment with chemotherapy or radiopharmaceutical therapy for mCRPC (except prior chemotherapy plus ADT for castration-sensitive disease, including docetaxel plus darolutamide).
5. Subjects with uncontrolled type 1 or type 2 diabetes
9\. Known and untreated, or active, brain or leptomeningeal metastases. Subjects with previously treated central nervous system (CNS) metastases may be enrolled in the study if they meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment within at least 4 weeks prior to randomization 10. History of clinically significant cardiovascular abnormalities 11. Gastrointestinal tract disease resulting in an inability to absorb oral medication as well as history of inflammatory bowel disease 12. Unable to swallow oral medication tablets/capsules
18 Years
MALE
No
Sponsors
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Celcuity Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Nadene Zack, MS
Role: STUDY_DIRECTOR
Celcuity Inc
Locations
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Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Centre Jean Perrin
Clermont-Ferrand, , France
Institut Paoli-Calmettes
Marseille, , France
Centre Antoine Lacassagne
Nice, , France
Institut Gustave Roussy
Villejuif, , France
Hospital Clinic Barcelona
Barcelona, , Spain
Institut Catala d'Oncologia
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Instituto Valenciano de Oncología
Valencia, , Spain
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospita
Cambridge, , United Kingdom
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital
Southampton, , United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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CELC-G-201
Identifier Type: -
Identifier Source: org_study_id
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