A Phase 2 Study of ONC206 in Advanced Pheochromocytoma and Paraganglioma
Jazz Pharmaceuticals
Summary
This is a two-stage Phase 2 trial evaluating the efficacy and safety of ONC206 in participants with Pheochromocytoma and Paraganglioma (PCPG).
Description
Two-Stage Study to evaluate ONC206 as monotherapy doses: Stage 1: Participants will receive 150mg ONC206 twice daily, on three consecutive days per week (BID TIW) in each 28-day cycle. * Part A: Initial number of participants will be monitored. * Part B: If a set number of participants have a response, then more participants will be enrolled and treated. Stage 2: If Stage 1 meets the planned response, the study will proceed, and participants will be randomized 1:1 to receive 1 of 2 ONC206 dose levels.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: 1. Has histologically confirmed pheochromocytoma or paraganglioma that is unresectable as determined by the Investigator. 2. 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. 3. Must have measurable disease per RECIST v1.1, as assessed by the Investigator. 4. 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 d…
Interventions
- DrugONC206
150 mg BID TIW
- DrugONC206: Dose 1
- DrugONC206: Dose 2
Locations (9)
- UCLALos Angeles, California
- StanfordPalo Alto, California
- U of ColoradoAurora, Colorado
- U of MichiganAnn Arbor, Michigan
- Mayo-RochesterRochester, Minnesota
- Washington UniversitySt Louis, Missouri