Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05252390
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2022-01-28
Brief Title:
NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
Sponsor:
Nuvation Bio Inc
Organization:
Nuvation Bio Inc
Study Overview
Official Title:
Phase 12 Safety and Efficacy Study of NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
NUV-868-01 is a first-in human open- label Phase 12 dose escalation and expansion study in patients with advanced solid tumors The Phase 1 and 1b portions include patients with advanced solid tumors and are designed to determine the safety and the doses of NUV-868 to be used as monotherapy and in combination with olaparib or enzalutamide for the Phase 2 portion In Phase 2 NUV-868 in combination with olaparib or enzalutamide will be given to determine the safety and efficacy of these study treatments One cohort of patients with enzalutamide-naïve metastatic castration-resistant prostate cancer will be randomized to receive either NUV-868 monotherapy enzalutamide monotherapy or the combination of NUV-868 enzalutamide Patients will self-administer NUV-868 orally daily in 28-day cycles as monotherapy in Phases 1 and 2 In Phases 1b and 2 patients will self-administer NUV-868 orally daily in 28-day cycles in combination with olaparib or enzalutamide daily at standard prescribed doses Phase 1b or at the recommended Phase 2 combination dose RP2cD that is determined in Phase 1b Patients will be treated until disease progression toxicity withdrawal of consent or termination of the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None