Ignite Creation Date:
2024-05-06 @ 10:35 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03303339
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2017-09-06
Brief Title:
Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia AML
Sponsor:
Cardiff Oncology
Organization:
Cardiff Oncology
Study Overview
Official Title:
A Phase 1b2 Study of PCM-075 Onvansertib in Combination With Either Low-Dose Cytarabine or Decitabine in Subjects With Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2022-12
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:
The purpose of the phase 1b2 study is to determine whether Onvansertib given orally daily for 5 consecutive days every 28 days is safe and tolerable in adult patients who have relapsedrefractory Acute Myeloid Leukemia AML or are ineligible for intensive induction therapy and to determine the maximum tolerated dose and recommended phase 2 dose of Onvansertib in combination with decitabine or Onvansertib in combination with low-dose cytarabine In the phase 2 portion of the study Onvansertib in combination with decitabine will be studied to provide further data on the safety profile of the combination and to preliminarily assess the activity of the chosen combination in patients with untreated AML who are not candidates for aggressive induction therapy or who have received one prior treatment for their AML
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1201-6416 | OTHER | WHO | None |