Ignite Creation Date:
2024-05-06 @ 6:06 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05549661
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2022-09-19
Brief Title:
Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase 1 Study to Determine the Safety and Efficacy of Onvansertib A Novel Oral PLK1 Inhibitor in Patients With Proliferative Chronic Myelomonocytic Leukemia CMML RelapsedRefractory or Intolerant to Available Therapies
Status:
RECRUITING
Status Verified Date:
2024-06
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 evaluates the safety effectiveness and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia that has come back recurrent or that does not respond to treatment refractory Onvansertib is a drug that binds to and inhibits an enzyme called PLK1 preventing cancer cell proliferation and causing cell death
Detailed Description:
PRIMARY OBJECTIVE
I Characterization of adverse events AEs by type incidence severity graded by National Cancer Institute Common Terminology Criteria for Adverse Events NCI-CTCAE version 50 seriousness and relationship to treatment effects on vital signs and laboratory parameters changes from baseline in electrocardiograms ECGs physical examinations weight and Eastern Cooperative Oncology Group ECOG performance status
SECONDARY OBJECTIVES
I Efficacy complete response CR rate according to the 2015 myelodysplastic syndrome MDSmyeloproliferative neoplasm MPN International Working Group IWG criteria
II Overall remission rate ORR defined as CR complete cytogenetic remission partial remission CR complete cytogenetic remission CCR partial remission PR
III Volumetric spleen response rate as determined by ultrasound scan US IV Constitutional symptoms as assessed by the MPN-Symptom Assessment Form SAF total symptom score TSS
EXPLORATORY OBJECTIVES
I Onvansertib activity in RAS mutant subtypes of proliferative chronic myelomonocytic leukemia CMML
II Monocyte subset analysis by flow cytometry CD14CD16 III Relation of genomic backgrounds and changes as assessed by next generation sequencing NGS to response
IV Relation between changes in mutant circulating-tumor deoxyribonucleic acid ctDNA and response
V CR rate ORR and spleen response rate as per the 2015 MDSMPN IWG response criteria
VI Assessment of target engagement VII Expression levels of PLK1 and KMT2A
OUTLINE This is a dose-escalation study of onvansertib followed by a dose-expansion study
Patients receive onvansertib orally PO once daily QD on study Patients also undergo bone marrow aspiration and biopsy collection of blood samples and ultrasound imaging during screening and throughout the trial
I Characterization of adverse events AEs by type incidence severity graded by National Cancer Institute Common Terminology Criteria for Adverse Events NCI-CTCAE version 50 seriousness and relationship to treatment effects on vital signs and laboratory parameters changes from baseline in electrocardiograms ECGs physical examinations weight and Eastern Cooperative Oncology Group ECOG performance status
SECONDARY OBJECTIVES
I Efficacy complete response CR rate according to the 2015 myelodysplastic syndrome MDSmyeloproliferative neoplasm MPN International Working Group IWG criteria
II Overall remission rate ORR defined as CR complete cytogenetic remission partial remission CR complete cytogenetic remission CCR partial remission PR
III Volumetric spleen response rate as determined by ultrasound scan US IV Constitutional symptoms as assessed by the MPN-Symptom Assessment Form SAF total symptom score TSS
EXPLORATORY OBJECTIVES
I Onvansertib activity in RAS mutant subtypes of proliferative chronic myelomonocytic leukemia CMML
II Monocyte subset analysis by flow cytometry CD14CD16 III Relation of genomic backgrounds and changes as assessed by next generation sequencing NGS to response
IV Relation between changes in mutant circulating-tumor deoxyribonucleic acid ctDNA and response
V CR rate ORR and spleen response rate as per the 2015 MDSMPN IWG response criteria
VI Assessment of target engagement VII Expression levels of PLK1 and KMT2A
OUTLINE This is a dose-escalation study of onvansertib followed by a dose-expansion study
Patients receive onvansertib orally PO once daily QD on study Patients also undergo bone marrow aspiration and biopsy collection of blood samples and ultrasound imaging during screening and throughout the trial
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2022-07695 | REGISTRY | CTRP Clinical Trial Reporting Program | None |