At a glance
ClinicalIndex Comparison Record- ✓Unresectable, recurrent, locally advanced, refractory, or metastatic neuroendocrine tumor including pheochromocytoma-paraganglioma (PC-PG), DSRCT, Ewing Sarcoma or PNET, or any neuroendocrine tumor with catecholamine or dopamine biomarker or autocrine or paracrine dependence on dopamine including cholangiocarcinoma and adrenal cortical carcinoma (ACC)
- ✓Age 14 years or older
- ✓At least 1 lesion detectable on CT, MRI, or 18FDG PET-CT
- ✓Ability to understand and willingness to sign written informed consent
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Study of ONC201 in Neuroendocrine Tumors
In Brief
A Phase 2 clinical trial evaluating ONC201 for Recurrent Neuroendocrine Tumor and Metastatic Neuroendocrine Tumor. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
625mg ONC201 will be given on two consecutive days each week