Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer : A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
This is a Phase 1/2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and pharmacokinetics of gedatolisib, a pan-PI3K/mTOR inhibitor, in combination with darolutamide, a next-generation androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer following progression on a next-generation androgen receptor inhibitor. The aim of the Phase 1 portion of the study is to evaluate dose limiting toxicities and to determine the recommended Phase 2 dose. The aim of the Phase 2 portion of the study is to further assess the safety and preliminary efficacy of the drug combination..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 09. Apr. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: January 5, 2024, Last downloaded: ClinicalTrials.gov processed this data on April 17, 2024, Last updated: April 17, 2024 |
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| Study ID: |
NCT06190899 |
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| Veröffentlichungen zur Studie: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG009544844 |
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| 245 | 1 | 0 | |a Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer |b A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: January 5, 2024, Last downloaded: ClinicalTrials.gov processed this data on April 17, 2024, Last updated: April 17, 2024 | ||
| 520 | |a This is a Phase 1/2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and pharmacokinetics of gedatolisib, a pan-PI3K/mTOR inhibitor, in combination with darolutamide, a next-generation androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer following progression on a next-generation androgen receptor inhibitor. The aim of the Phase 1 portion of the study is to evaluate dose limiting toxicities and to determine the recommended Phase 2 dose. The aim of the Phase 2 portion of the study is to further assess the safety and preliminary efficacy of the drug combination. | ||
| 650 | 2 | |a Prostatic Neoplasms | |
| 650 | 2 | |a Prostatic Neoplasms, Castration-Resistant | |
| 650 | 2 | |a Genital Diseases | |
| 650 | 2 | |a Urogenital Diseases | |
| 650 | 2 | |a Prostatic Diseases | |
| 650 | 2 | |a Genital Diseases, Male | |
| 650 | 2 | |a Male Urogenital Diseases | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Recruiting | |
| 650 | 4 | |a Phase: Phase 1, Phase 2 | |
| 650 | 4 | |a 610 | |
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