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New treatment option for Advanced Pheochromocytoma and Paraganglioma
Official title Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma
ClinicalTrials.gov ID: NCT07282587
What this study is testing
What is ONC206?
ONC206 is an investigational medicine, given as an once-daily, being studied as a potential treatment for advanced pheochromocytoma and paraganglioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a two-stage Phase 2 trial evaluating the efficacy and safety of ONC206 in participants with Pheochromocytoma and Paraganglioma (PCPG).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has histologically confirmed pheochromocytoma or paraganglioma that is unresectable as determined by the Investigator.
- Has failed, is not a candidate for, or has declined standard of care treatment for PCPG. There is no limit on the number of prior systemic therapies.
- Must have measurable disease per RECIST v1.1, as assessed by the Investigator.
- Has adequately controlled blood pressure defined as blood pressure ≤150/90 mmHg and with no change in antihypertensive medications (for participants...
- Is ≥18 years of age.
You likely can't join if
- Has known hypersensitivity to ONC206 or any excipient used in the ONC206 study treatment formulation.
- Has active cardiac disease/condition including any of the following:
- Corrected QT interval (QTc) \>480 msec (based on the mean from triplicate electrocardiogram [ECGs] performed during Screening).
- History of documented congestive heart failure (New York Heart Association function classification III-IV).
- Unstable angina, acute myocardial infarction, or arterial bypass or percutaneous transluminal coronary angioplasty within 6 months before the first...
- Has previous exposure to ONC206 or dordaviprone (ONC201) from any source.
See the full eligibility criteria
- Has histologically confirmed pheochromocytoma or paraganglioma that is unresectable as determined by the Investigator.
- Has failed, is not a candidate for, or has declined standard of care treatment for PCPG. There is no limit on the number of prior systemic therapies.
- Must have measurable disease per RECIST v1.1, as assessed by the Investigator.
- Has adequately controlled blood pressure defined as blood pressure ≤150/90 mmHg and with no change in antihypertensive medications (for participants with concomitant hypertension) for at least 14 days before the first...
- Is ≥18 years of age.
- Is able to swallow oral tablets.
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2, assessed within 7 days before the first dose of study treatment.
- Has laboratory test results meeting the following parameters within 14 days before the first dose of study treatment
- Has an expected survival of at least 12 weeks, as predicted by the physician.
- Has pharmacologic control of catecholamine-associated symptoms if participant has functional disease.
- Has known hypersensitivity to ONC206 or any excipient used in the ONC206 study treatment formulation.
- Has active cardiac disease/condition including any of the following:
- Corrected QT interval (QTc) \>480 msec (based on the mean from triplicate electrocardiogram [ECGs] performed during Screening).
- History of documented congestive heart failure (New York Heart Association function classification III-IV).
- Unstable angina, acute myocardial infarction, or arterial bypass or percutaneous transluminal coronary angioplasty within 6 months before the first dose of study treatment.
- Has previous exposure to ONC206 or dordaviprone (ONC201) from any source.
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Exceptions include participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin...
- Has received any of the following interventions within the specified time periods before the first dose of study treatment or plans to receive any of the following interventions during study participation:
- a. Any prior anticancer therapy or investigational agents within 4 weeks or 5 half-lives, whichever is shorter. Note: Denosumab and zoledronic acid are permissible. \ \ i. Any treatment with somatostatin analog or...
- b. Strong cytochrome P450 (CYP) inhibitors within 14 days. c. Strong CYP inducers within 14 days. d. Any radiotherapy within 14 days. e. Any major surgery, open biopsy or significant traumatic injury within 1 month (30...
- Is pregnant, breastfeeding, or planning to become pregnant while receiving study treatment or within 3 months after the last dose.
- Has uncontrolled intercurrent illness or any other medical, psychiatric, or social condition that, in the opinion of the Investigator, may interfere with participant safety or the ability to comply with study...
- Has unresolved toxicities from previous locoregional, systemic, or any other therapies, defined as toxicities (other than Grade ≤2 neuropathy or alopecia) not yet resolved to the National Cancer Institute Common...
- Has an active infection that requires systemic therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Palo Alto, California, United States; Aurora, Colorado, United States; Ann Arbor, Michigan, United States; Rochester, Minnesota, United States; St Louis, Missouri, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.