Actively Recruiting
Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma
Led by Jazz Pharmaceuticals · Updated on 2026-02-27
90
Participants Needed
9
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a two-stage Phase 2 trial evaluating the efficacy and safety of ONC206 in participants with Pheochromocytoma and Paraganglioma (PCPG).
CONDITIONS
Official Title
Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed pheochromocytoma or paraganglioma that cannot be surgically removed
- Failed, not a candidate for, or declined standard treatments for PCPG, with no limit on prior therapies
- Measurable disease according to RECIST v1.1 criteria
- Blood pressure controlled at or below 150/90 mmHg with no medication changes for at least 14 days before treatment
- At least 18 years old
- Able to swallow oral tablets
- ECOG Performance Status between 0 and 2 within 7 days before treatment
- Laboratory test results within acceptable ranges within 14 days before treatment
- Expected survival of at least 12 weeks as predicted by a physician
- Pharmacologic control of catecholamine-related symptoms if disease is functional
You will not qualify if you...
- Known allergy to ONC206 or any ingredient in the study treatment
- Active heart conditions including QTc over 480 msec, severe heart failure (NYHA class III-IV), unstable angina, recent heart attack, or recent coronary procedures within 6 months
- Previous treatment with ONC206 or dordaviprone (ONC201)
- Another progressing cancer requiring treatment within the past 2 years, except certain skin cancers and Von Hippel-Lindau disease tumors without immediate intervention
- Recent anticancer therapy or investigational treatments within 4 weeks or 5 half-lives, except denosumab and zoledronic acid
- Recent somatostatin analog or lanreotide treatment within 21 days before PET scan
- Use of strong cytochrome P450 inhibitors or inducers within 14 days
- Radiotherapy within 14 days
- Major surgery, open biopsy, or significant injury within 30 days
- Pregnant, breastfeeding, or planning pregnancy during treatment and up to 3 months after
- Uncontrolled illness or medical, psychiatric, or social conditions that may affect safety or study compliance
- Unresolved toxicities from prior treatments above Grade 2 neuropathy or alopecia
- Active infection requiring systemic therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
2
Stanford
Palo Alto, California, United States, 94604
Actively Recruiting
3
U of Colorado
Aurora, Colorado, United States, 80045
Not Yet Recruiting
4
U of Michigan
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
5
Mayo-Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
6
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Columbia University Medical Center
New York, New York, United States, 10032
Not Yet Recruiting
8
PENN
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
UTAH
Salt Lake City, Utah, United States, 84112
Not Yet Recruiting
Research Team
C
Clinical Trial Disclosure & Transparency
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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