Dovitinib in Neuroendocrine Tumors

NCT01635907 | Completed Phase 2 DMC

• 1 other identifier: UPCC 23811
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Metastatic Paraganglioma; Advanced Metastatic Pheochromocytoma; Recurrent Paraganglioma; Recurrent Pheochromocytoma; Unresectable Paraganglioma; Unresectable Pheochromocytoma

Outcome Measures

Primary Outcomes (1)

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

  using RECIST criteria

  2 years

Study Arms (1)

Dovitinib

EXPERIMENTAL

Drug: Dovitinib

Interventions

Dovitinib DRUG

Dovitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Paraganglioma; Pheochromocytoma

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Stephen Keefe, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: April 11, 2016
• Last Updated: April 14, 2020

Record last verified: 2020-04

Locations

US (1)