Phase 2
N=25
Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma
Paraganglioma · Pheochromocytoma
Bottom Line
View on ClinicalTrials.gov: NCT00843037 ↗Enrolled (actual)
25
Serious AEs
40.0%
Results posted
Oct 2024
Primary outcome: Primary: Clinical Benefit Rate (CBR) Which is Defined as Either a Partial Response (PR) Complete Response (CR) or Stable Disease (SD) for ≥ 12 Weeks Measured Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. — 19; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sunitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Health Network, Toronto
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Benefit Rate (CBR) Which is Defined as Either a Partial Response (PR) Complete Response (CR) or Stable Disease (SD) for ≥ 12 Weeks Measured Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. |
19; 4 | — |
| SECONDARY Biochemical Response (BCR) of > 20% Drop in 24-hour Urinary Metanephrines, Catecholamines or Serum Chromogranin A, Sustained for > 12-week Period |
7; 5; 7; 5; 4; 1 | — |
| SECONDARY Overall Survival |
112 | — |
| SECONDARY Time to Progression |
13.4 | — |
| SECONDARY Overall Response Rate (PR) + (CR) |
3; 20 | — |
Summary
This is an open-label phase II study of an investigational drug, sunitinib malate in patients with advanced malignant paraganglioma or phaeochromocytoma cancer. Paragangliomas (PGs) are tumours that arise from the para-sympathetic system in the head and neck and sympathetic system in the thorax and abdomen. Paragangliomas that secrete hormones (catecholamines) from the adrenal glands are called pheochromocytomas (PCs). In this study, patients whose disease has advanced or spread despite prior standard therapy, will receive sunitinib for 4-weeks followed by a 2-week rest period, for up to 12 months, in the absence of disease progression. Sunitinib is an investigational drug, which has been shown to shrink tumours in several tumour models. The study will evaluate the efficacy as well as the toxicity profile of sunitinib when used as an alternative treatment for patients with PG/PC tumours.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of malignant paraganglioma or pheochromocytoma and either evidence of metastases or unresectability.
- Evidence of recent disease progression (radiological, biochemical, symptomatic).
- Measurable disease defined as that which can be measured in at least one dimension with a minimum size of 10 mm by CT scan.
- ECOG 0-2.
- Life expectancy of greater than 24 weeks.
- Age > 18 years.
- Patients must have normal organ and marrow function.
- Patients must have PT/INR/PTT within 1.2 X the upper limit
- Patients may have had prior radiation therapy. A minimum of 28 days must have elapsed between the end of radiotherapy and registration onto the study.
- Previous Surgery: Previous major surgery is permitted provided that it has been at least 28 days prior to patient registration
- Laboratory Requirements Parameter Limit granulocytes (AGC) > 1.5 x 109/L platelets > 100 x 109/L bilirubin 1g urinary protein/24hrs
Data sourced from ClinicalTrials.gov (NCT00843037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.