Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606990
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Testing How the Body Responds to the Drug CX-5461 Pidnarulex in Patients With Metastatic Solid Cancers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Study of Pidnarulex Pharmacodynamics in Patients With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial tests the safety side effects and best dose of pidnarulex CX-5461 in treating patients with solid tumors that has spread from where it first started primary site to other places in the body metastatic Pidnarulex is an oral inhibitor of ribonucleic acid RNA polymerase I Pol I with potential antineoplastic activity It blocks a certain enzyme needed for cell division and deoxyribonucleic acid DNA repair and may kill cancer cells Giving pidnarulex may be safe tolerable andor effective in treating patients with metastatic solid tumors
Detailed Description:
PRIMARY OBJECTIVE
I To assess whether pidnarulex induces a Rad51 response which will be determined by an integral biomarker of percentage of cells with Rad51 nuclear foci in tumor biopsy specimens in patients with and without homologous repair deficiency HRD genetic mutations
SECONDARY OBJECTIVES
I To determine the safety and tolerability of pidnarulex II To determine the overall response rate complete responses plus partial responses in patients with advanced refractory solid tumors
III To measure the pharmacokinetics of pidnarulex IV To evaluate other DNA damage and repair signaling markers including Top2 G4 stabilization RPA32 pSer33-RPA32 γH2AX 53BP1 pSer8-RPA32 pKap1m and pNBS1
EXPLORATORY OBJECTIVES
I To examine genomic alterations in circulating tumor DNA ctDNA that may be associated with response or resistance
OUTLINE
Patients receive pidnarulex intravenously IV over 60 minutes on days 1 and 8 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo tissue sample collection at baseline and on study computed tomography CT or magnetic resonance imaging MRI and optionally undergo blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days
I To assess whether pidnarulex induces a Rad51 response which will be determined by an integral biomarker of percentage of cells with Rad51 nuclear foci in tumor biopsy specimens in patients with and without homologous repair deficiency HRD genetic mutations
SECONDARY OBJECTIVES
I To determine the safety and tolerability of pidnarulex II To determine the overall response rate complete responses plus partial responses in patients with advanced refractory solid tumors
III To measure the pharmacokinetics of pidnarulex IV To evaluate other DNA damage and repair signaling markers including Top2 G4 stabilization RPA32 pSer33-RPA32 γH2AX 53BP1 pSer8-RPA32 pKap1m and pNBS1
EXPLORATORY OBJECTIVES
I To examine genomic alterations in circulating tumor DNA ctDNA that may be associated with response or resistance
OUTLINE
Patients receive pidnarulex intravenously IV over 60 minutes on days 1 and 8 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo tissue sample collection at baseline and on study computed tomography CT or magnetic resonance imaging MRI and optionally undergo blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None