Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04541225
Status:
TERMINATED
Last Update Posted:
2023-07-14
First Post:
2020-08-21
Brief Title:
Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors
Sponsor:
Nuvation Bio Inc
Organization:
Nuvation Bio Inc
Study Overview
Official Title:
Phase 12 Dose Escalation Safety Pharmacokinetics and Efficacy Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
At the time of study termination NUV-422-02 was a first-in-human open-label Phase 1 dose escalation study designed to evaluate the safety and efficacy of NUV-422 The study population comprised adults with recurrent or refractory high-grade gliomas HGGs metastatic breast cancer mBC with and without brain metastases and recurrent or refractory metastatic castration-resistant prostate cancer mCRPC All patients self-administered NUV-422 orally in 28-day cycles 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