Ignite Creation Date:
2024-05-06 @ 9:51 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03099499
Status:
TERMINATED
Last Update Posted:
2024-01-16
First Post:
2017-03-23
Brief Title:
Single Agent ONC201 in Recurrent or Metastatic Endometrial Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Phase 2 Study of Single Agent ONC201 in Recurrent or Metastatic Endometrial Cancer
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ONC201 is a small molecule which selectively targets the G protein-coupled receptor DRD2 Downstream of target engagement ONC201 activates the integrated stress response ISR in tumor cell leading to inactivation of Akt and extracellular signal-regulated kinase ERK signaling as well as induction of the TRAIL pathway ONC201 also inhibits dopamine receptor 2 DRD2 resulting in anti-tumor responses in preclinical models Single agent ONC201 has been examined in open-label Phase I studies in patients with advanced treatment refractory solid malignancies Due to its differential anti-proliferative and pro-apoptotic response in tumor cells treatment was overall well tolerated and the recommended phase II dose of ONC201 was set at 625mg every three weeks An additional dose-escalation phase I study NCT02609230 is further evaluating weekly versus three week dosing in patients with advanced solid tumors and multiple myeloma Preliminary data from these phase I studies suggests a possible clinical benefit in patients with advanced chemo-refractory endometrial cancers with at least one mixed response noted in a patient with clear cell histology
Hypothesis Single agent ONC201 will demonstrate clinical benefit in women with recurrent or metastatic endometrial cancers especially in those women with alterations in the Phosphoinositide 3 kinase PI3KAktmammalian target of Rapamycin mTOR pathway
Hypothesis Single agent ONC201 will demonstrate clinical benefit in women with recurrent or metastatic endometrial cancers especially in those women with alterations in the Phosphoinositide 3 kinase PI3KAktmammalian target of Rapamycin mTOR pathway
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