Dovitinib in Neuroendocrine Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Stephen Keefe,MD, Principal Investigator
Beth Fox, MD , Sponsor Investigator
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01635907
First received: July 5, 2012
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Advanced Metastatic Paraganglioma
Advanced Metastatic Pheochromocytoma
Recurrent Paraganglioma
Recurrent Pheochromocytoma
Unresectable Paraganglioma
Unresectable Pheochromocytoma
Drug: Dovitinib
Phase 2

Abramson Cancer Center of the University of Pennsylvania has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Dovitinib in Adults With Advanced Malignant Pheochromocytoma or Paraganglioma

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Number of Adverse Events [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635907

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Stephen Keefe,MD, Principal Investigator
Beth Fox, MD , Sponsor Investigator
Investigators
Principal Investigator: Stephen Keefe, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01635907     History of Changes
Other Study ID Numbers: UPCC 23811
Study First Received: July 5, 2012
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Paraganglioma
Pheochromocytoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors

ClinicalTrials.gov processed this record on October 23, 2014