Ignite Creation Date:
2024-05-06 @ 9:38 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03034200
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2017-01-25
Brief Title:
Phase 2 Study of ONC201 in Neuroendocrine Tumors
Sponsor:
Peter Anderson
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase 2 Study of ONC201 in Neuroendocrine Tumors
Status:
COMPLETED
Status Verified Date:
2022-04
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 this study is to learn if a new drug ONC201 can make tumors become smaller or go away completely Investigators also want to learn if ONC201 can prevent new deposits of cancer from appearing in new places in participants metastases A phase 2 study of ONC201 in PC-PG pheochromocytoma-paraganglioma and other neuroendocrine tumors will determine whether inhibition of DRD2 a member of the dopamine receptor family is safe in unresectable recurrent locally advanced refractory or metastatic neuroendocrine cancers including PC-PG desmoplastic small round cell tumor DSRCT Ewing sarcoma PNET or any other neuroendicrine tumor with a catecholamine or dopamine biomarker or autocrine or paracrine dependence on dopamine including cholangiocarcinoma and adrenal cortical carcinoma
ONC201 is an investigational experimental agent and has a favorable safety profile in phase 1 and early phase 2 clinical trials in advanced cancers This study design has been chosen to see whether ONC201 is associated with reduction of anti-hypertension medications safety and significant efficacy against neuroendocrine tumors especially PC-PG
ONC201 is an investigational experimental agent and has a favorable safety profile in phase 1 and early phase 2 clinical trials in advanced cancers This study design has been chosen to see whether ONC201 is associated with reduction of anti-hypertension medications safety and significant efficacy against neuroendocrine tumors especially PC-PG
Detailed Description:
Primary Objective To demonstrate objective responses using MRI or CT andor PET-CT imaging The same CT or MRI imaging to assess disease burden at study entry will be compared at week 6 and 3 months Patients without progression at 3 months will continue treatment and have imaging at 6 9 and 12 months after study entry Metabolic response andor biomarkers will be compared with study entry PET-CT and scans at 6 weeks 3 months and 12 months
Secondary Objectives Progression - free Survival This will be calculated according to Response Evaluation Criteria In Solid Tumors RECIST or development of new disease
Overall survival Overall survival will be determined by email or telephone contact
Study Design Phase 2 open-label fixed dose study Metastatic neuroendocrine tumors including PC-PG are rare diseases
The current recommended phase II dose of 625 mg orally on 2 consecutive days every week will be used The same imaging at study entry will be used at subsequent time points CT or MRI for week 6 and 3 6 9 and 12 months Imaging modality choice will be influenced by the quality of prior scans of the subject and will be ordered so clinical comparison is possible
Because of travel and lodging considerations associated with the COVID-19 pandemic some information by the study teamPI may be obtained using virtual visits and 2nd read of scans sent to Cleveland Clinic
Secondary Objectives Progression - free Survival This will be calculated according to Response Evaluation Criteria In Solid Tumors RECIST or development of new disease
Overall survival Overall survival will be determined by email or telephone contact
Study Design Phase 2 open-label fixed dose study Metastatic neuroendocrine tumors including PC-PG are rare diseases
The current recommended phase II dose of 625 mg orally on 2 consecutive days every week will be used The same imaging at study entry will be used at subsequent time points CT or MRI for week 6 and 3 6 9 and 12 months Imaging modality choice will be influenced by the quality of prior scans of the subject and will be ordered so clinical comparison is possible
Because of travel and lodging considerations associated with the COVID-19 pandemic some information by the study teamPI may be obtained using virtual visits and 2nd read of scans sent to Cleveland Clinic
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