Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJazz Pharmaceuticals
About this trial
This is a two-stage Phase 2 trial evaluating the efficacy and safety of ONC206 in participants with Pheochromocytoma and Paraganglioma (PCPG).
Eligibility criteria
Qualifiers
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 dose of study treatment.
Disqualifiers
Has known hypersensitivity to ONC206 or any excipient used in the ONC206 study treatment formulation.
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.
Trial design
Treatments tested in this trial
- ONC206
- ONC206: Dose 1
- ONC206: Dose 2
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov