Health TrialsbyHealthPanel

Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma

ConditionsAdvanced Pheochromocytoma and ParagangliomaPCPG
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • ONC206

    Drug

    150 mg BID TIW

  • ONC206: Dose 1

    Drug

  • ONC206: Dose 2

    Drug

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Stage 1 ParticipantsExperimental treatment 1 intervention
Group B: Stage 2: Dose 1Experimental treatment 1 intervention
Group C: Stage 2: Dose 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

ORR defined as the number of participants with a confirmed complete response (CR) or partial response during the study, as per RECIST v1.1.

Time frame
Up to 36 months.

Secondary outcomes

1

Duration of Response (DOR)

Time frame
Up to 36 months.
2

Time to Response (TTR)

Time frame
Up to 36 months.
3

Disease Control Rate (DCR)

Time frame
Up to 36 months.
4

Progression Free Survival (PFS) by RECIST v1.1

Time frame
Up to 36 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jazz Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
Apply now