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Dovitinib in Neuroendocrine Tumors

Primary Purpose

Advanced Metastatic Paraganglioma, Advanced Metastatic Pheochromocytoma, Recurrent Paraganglioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dovitinib
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Metastatic Paraganglioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with advanced, metastatic, recurrent or unresectable paraganglioma or pheochromocytoma. Pathology report or pathology slides (H&E) confirming histological diagnosis must be available at the time of enrollment.
  • Must have measurable disease by RECIST v1.1.
  • ECOG performance status 0, 1, 2
  • Age greater or equal to 18 years old
  • Adequate laboratory results; negative pregnancy test (females of childbearing potential)
  • Patients who give a written informed consent obtained according to institutional guidelines

Exclusion Criteria:

  • Patients with known untreated brain metastases are excluded. Patients having a history of brain metastasis that have been previously irradiated or resected greater than 3 months prior to enrollment and are clinically and radiographically stable will be considered for enrollment.
  • Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer)
  • Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies (but excluding nitrosurea, mitomycin-C, targeted therapy and radiation) less than or equal to 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
  • Patients who have received the last administration of nitrosurea or mitomycin-C less than or equal to 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
  • Patients who have received bevacizumab, sunitinib, sorafenib, or pazopanib less than or equal to 2 weeks prior to starting study drug, or who have not recovered (grade 1) from the side effects of these therapies.
  • Patients who have had radiotherapy less than or equal to 4 weeks prior to starting study drug, or less than or equal to 2 weeks prior to starting study drug in the case of localized radiotherapy (e.g. for analgesic purpose or for lytic lesions at risk of fracture), or who have not recovered from radiotherapy toxicities
  • Patients who have had therapeutic radiolabeled MIBG or other systemic radiolabeled therapy less than or equal to 4 weeks prior to starting study drug,
  • Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury less than or equal to 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
  • Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study (i.e. impaired cardiac function or clinically significant cardiac diseases, etc).
  • Pregnant or breastfeeding women or any subjects who refuse to use protocol required contraception
  • Patients unwilling or unable to comply with the protocol

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dovitinib

Arm Description

Outcomes

Primary Outcome Measures

to determine the objective response rate of dovitinib in subjects with advanced malignant pheochromocytoma or paraganglioma
using RECIST criteria

Secondary Outcome Measures

Full Information

First Posted
July 5, 2012
Last Updated
April 9, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01635907
Brief Title
Dovitinib in Neuroendocrine Tumors
Official Title
A Phase 2 Study of Dovitinib in Adults With Advanced Malignant Pheochromocytoma or Paraganglioma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is being conducted to evaluate whether the investigational drug Dovitinib, can shrink or slow the growth of cancer in patients with certain types of neuroendocrine tumors. This study will also further evaluate the safety of this drug.
Detailed Description
This investigator-initiated study is being conducted to evaluate whether the investigational drug, Dovitinib, can shrink or slow the growth of cancer in patients with certain types of neuroendocrine tumors (advanced malignant pheochromocytoma or paraganglioma). The primary endpoint will be response rate (Complete + Partial Response) determined by RECIST v 1.1. 25 subjects will be enrolled on this study at the University of Pennsylvania.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Metastatic Paraganglioma, Advanced Metastatic Pheochromocytoma, Recurrent Paraganglioma, Recurrent Pheochromocytoma, Unresectable Paraganglioma, Unresectable Pheochromocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dovitinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dovitinib
Primary Outcome Measure Information:
Title
to determine the objective response rate of dovitinib in subjects with advanced malignant pheochromocytoma or paraganglioma
Description
using RECIST criteria
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with advanced, metastatic, recurrent or unresectable paraganglioma or pheochromocytoma. Pathology report or pathology slides (H&E) confirming histological diagnosis must be available at the time of enrollment. Must have measurable disease by RECIST v1.1. ECOG performance status 0, 1, 2 Age greater or equal to 18 years old Adequate laboratory results; negative pregnancy test (females of childbearing potential) Patients who give a written informed consent obtained according to institutional guidelines Exclusion Criteria: Patients with known untreated brain metastases are excluded. Patients having a history of brain metastasis that have been previously irradiated or resected greater than 3 months prior to enrollment and are clinically and radiographically stable will be considered for enrollment. Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer) Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies (but excluding nitrosurea, mitomycin-C, targeted therapy and radiation) less than or equal to 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy Patients who have received the last administration of nitrosurea or mitomycin-C less than or equal to 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy Patients who have received bevacizumab, sunitinib, sorafenib, or pazopanib less than or equal to 2 weeks prior to starting study drug, or who have not recovered (grade 1) from the side effects of these therapies. Patients who have had radiotherapy less than or equal to 4 weeks prior to starting study drug, or less than or equal to 2 weeks prior to starting study drug in the case of localized radiotherapy (e.g. for analgesic purpose or for lytic lesions at risk of fracture), or who have not recovered from radiotherapy toxicities Patients who have had therapeutic radiolabeled MIBG or other systemic radiolabeled therapy less than or equal to 4 weeks prior to starting study drug, Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury less than or equal to 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study (i.e. impaired cardiac function or clinically significant cardiac diseases, etc). Pregnant or breastfeeding women or any subjects who refuse to use protocol required contraception Patients unwilling or unable to comply with the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Keefe, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Dovitinib in Neuroendocrine Tumors

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