Study on ONC206 for Advanced Pheochromocytoma and Paraganglioma
Sponsor: Jazz Pharmaceuticals
ClinicalTrials ID:NCT07282587
This clinical trial is testing the effectiveness and safety of a new drug, ONC206, for treating advanced Pheochromocytoma and Paraganglioma, which are rare types of tumors.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is being conducted in two stages to evaluate how well the drug ONC206 works and how safe it is for patients with advanced Pheochromocytoma and Paraganglioma. These are rare tumors that cannot be surgically removed. The trial will test different doses of ONC206 to find the most effective treatment plan.
Description
The study is divided into two stages:
Stage 1: Participants will take 150mg of ONC206 twice a day, three days a week, in a 28-day cycle. Initially, a small group of participants will be monitored. If enough participants show a positive response, more participants will be added to the study.
Stage 2: If Stage 1 shows promising results, the study will continue with participants randomly assigned to receive one of two different dose levels of ONC206.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with pheochromocytoma or paraganglioma that cannot be surgically removed.
- Have tried standard treatments without success or are not candidates for them.
- Have measurable disease based on specific medical criteria.
- Blood pressure must be controlled and stable for at least 14 days before starting the study.
- Must be 18 years or older.
- Able to swallow pills.
- Have a performance status score of 0 to 2, indicating good overall health.
- Meet specific laboratory test results before starting the study.
- Expected to live at least 12 more weeks.
- Have symptoms related to catecholamine under control if applicable.
Exclusion Criteria
- Allergic to ONC206 or its ingredients.
- Have certain heart conditions, such as prolonged QT interval or recent heart attack.
- Have previously taken ONC206 or a similar drug.
- Have another active cancer that needs treatment, except for certain skin cancers or non-threatening tumors.
- Have received certain treatments or medications within a specified time before starting the study.
- Pregnant, breastfeeding, or planning to become pregnant during or shortly after the study.
- Have uncontrolled illnesses or conditions that could interfere with the study.
- Have unresolved side effects from previous treatments.
- Have an active infection requiring treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCLA | 90095 | Los Angeles | California |
| Stanford | 94604 | Palo Alto | California |
| U of Colorado | 80045 | Aurora | Colorado |
| U of Michigan | 48109 | Ann Arbor | Michigan |
| Mayo-Rochester | 55905 | Rochester | Minnesota |
| Washington University | 63110 | St Louis | Missouri |
| Columbia University Medical Center | 10032 | New York | New York |
| PENN | 19104 | Philadelphia | Pennsylvania |
| UTAH | 84112 | Salt Lake City | Utah |
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