Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma (SNIPP)

January 25, 2023 updated by: University Health Network, Toronto

A Investigator Initiated Phase II Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be a single arm, open-label, phase II trial of sunitinib in patients with metastatic or locally advanced malignant paraganglioma or phaeochromocytoma. Oral sunitinib (50 mg) will be administered to all patients daily for the first four weeks of a six week study cycle, followed by a 2-week rest. Patients will be assessed for response to study treatment using MRI/CT scans as well as bio-chemical tests, and will receive the study treatment for up to 12 months or until disease progression.

Primary study outcomes include:

To assess the efficacy (response rate) of sunitinib given orally daily for 4 out of every 6 weeks in patients with advanced or metastatic paraganglioma/ pheochromocytoma.

To assess the toxicity of sunitinib in patients with advanced or metastatic paraganglioma/ pheochromocytoma.

To document effects of sunitinib on markers of biochemical activity of advanced or metastatic paraganglioma/ pheochromocytoma.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network, Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Hopital Notre-Dame du CHUM
  • Netherlands
      • Groningen, Netherlands
        • University Medical Centre Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 < 1.5XULN AST and ALT < 2.5 x ULN Amylase <1.5XULN Lipase <1.5XULN Calcium < 3 mmol/L creatinine < 2.0XULN

Exclusion Criteria:

  • History of other malignancies.
  • Patients with known brain metastases.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib.
  • Patients receiving concurrent treatment with other anti-cancer therapy given for paraganglioma or pheochromocytoma or other therapy or other investigational anticancer agents.
  • Patients who have received prior treatment with any other antiangiogenic agent or multi-targeted tyrosine kinase inhibitors are ineligible.
  • Patients with any of the following cardiovascular findings are to be excluded:
  • QTc prolongation or other significant ECG abnormalities.
  • Current or history of Class III or IV heart failure as defined by the NYHA functional classification system
  • Patients with prior anthracycline exposure, previous central thoracic radiation that included heart in radiation port, or a history of NYHA Class II cardiac function.
  • Poorly controlled hypertension
  • Myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry
  • History of venous thrombosis or pulmonary embolism in the past 3 months
  • History of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry
  • Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin
  • Patients with bowel obstruction or any condition that impairs their ability to swallow and retain sunitinib tablets.
  • Use of agents with proarrhythmic potential is not permitted during the study.
  • Must be able to stop prohibited selected CYP3A4 inhibitors/inducers prior to starting sunitinib
  • Patients with pre-existing hypothyroidism prior to enrolment are ineligible unless they are euthyroid on medication.
  • Pregnant or lactating women, positive pregnancy test, women of childbearing potential who do not agree to use adequate contraception prior to study entry and for the duration of study participation.
  • Known HIV-positive patients on combination antiretroviral therapy
  • Greater than +1 proteinuria on urinary dipstick if also >1g urinary protein/24hrs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open label - Sunitinib
Sunitinib, 50mg daily, once daily for 4 weeks followed by a 2-week break
Drug: Sunitinib
50 mg oral dose daily for 4 weeks, 2 week rest period (repeating 6 week cycles)
Other Names:
  • Sunitinib malate (suntinib; SU11248, SU011248, Sutent®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Every 12 weeks (2 cycles)
Every 12 weeks (2 cycles)

Secondary Outcome Measures

Outcome Measure
Time Frame
Biochemical response of > 20% drop in; 24-hour urinary metanephrines, catecholamines or serum chromogranin A, sustained for > 12-week period
Time Frame: Patient specific based on disease progression
Patient specific based on disease progression
Overall survival
Time Frame: Patient specific based on disease progression
Patient specific based on disease progression
Time to progression
Time Frame: Patient specific based on disease progression
Patient specific based on disease progression
Overall response rate (PR) + (CR)
Time Frame: Patient specific based on disease progression
Patient specific based on disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Pfizer

Investigators

  • Principal Investigator: Jennifer Knox, MD, FRCPC, The Princess Margaret Cancer Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2009

Primary Completion (Actual)

March 14, 2022

Study Completion (Actual)

March 14, 2022

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 12, 2009

First Posted (Estimate)

February 13, 2009

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNIPP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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