Dovitinib in Neuroendocrine Tumors

A Phase 2 Study of Dovitinib in Adults With Advanced Malignant Pheochromocytoma or Paraganglioma

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.

Study Overview

• Status: Completed
• Conditions: Unresectable Paraganglioma; Recurrent Pheochromocytoma; Advanced Metastatic Paraganglioma; Advanced Metastatic Pheochromocytoma; Recurrent Paraganglioma; Unresectable Pheochromocytoma
• Intervention / Treatment: Drug: Dovitinib

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dovitinib	Drug: Dovitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to determine the objective response rate of dovitinib in subjects with advanced malignant pheochromocytoma or paraganglioma	using RECIST criteria	2 years

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): April 11, 2016

Study Registration Dates

• First Submitted: July 5, 2012
• First Submitted That Met QC Criteria: July 9, 2012
• First Posted (ESTIMATE): July 10, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Recurrence; Pheochromocytoma; Paraganglioma
• Other Study ID Numbers: UPCC 23811