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Trial record 23 of 48 for:    Dovitinib

An Open-label, Multicenter, Phase II Study of Dovitinib in Advanced Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01964144
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
There has been no effective treatment for advanced thyroid cancer that is not amenable to surgery and that does not concentrate iodine. Response rates with chemotherapy have been so low that best supportive care has been the standard of care for most patients. In recent phase I and phase II clinical studies, dovitinib has shown activity as a single agent in solid tumors. Therefore, we will conduct a phase II, single-arm trial to determine the efficacy of dovitinib in radioactive iodine-refractory recurrent or metastatic thyroid cancer.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Drug: Dovitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dovitinib arm Drug: Dovitinib
Dovitinib 500mg (5 capsules x 100 mg/day) for 5 consecutive days and 2 days rest




Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 1 month after treatment ]
    Lesions measurements are performed by CT or MRI scan, evaluation by RECIST criteria v1.1



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven diagnosis of thyroid cancer (papillary, follicular/Hürthle cell variant, medullary)
  • Patients with metastatic or unresectable thyroid cancer for which curative measures (surgical resection, external-beam radiation therapy, or radioactive iodine) were no longer effective
  • Documented evidence of disease progression (based on radiographic imaging), according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, within 6 months before entry into the study for papillary follicular/Hürthle cell variant
  • Prior therapy with surgery, 131I treatment, chemotherapy, radiotherapy will be allowed, but not within 3 weeks of treatment.
  • Patients who received a prior biologic treatment (kinase inhibitor, vaccine or antibody-based therapy), except prior VEGFR/FGFR inhibitor therapy, can be allowed after 3 weeks of treatment.
  • Patients must have at least one measurable lesion, which has not been externally irradiated, as defined by RECIST criteria version 1.1
  • Age : 20-90
  • Performance status of Eastern Cooperative Oncology Group 0 to 2
  • Life expectancy > 3 months
  • Adequate bone marrow function: ANC≥1,500/uL, hemoglobin≥9.0 g/dL (can be corrected by transfusion) and platelet≥100,000/uL
  • Adequate renal function (creatinine<1.5 mg/dL)
  • Adequate liver function (total bilirubin <1.5 x ULN, trans-aminase <3 x ULN)
  • Adequate blood glucose and lipid level (at fasting cholesterol < 2xUNL, triglyceride < 2xUNL, HbA1c < 9%)
  • Patient compliance and geographic proximity that allow adequate follow up

Exclusion Criteria:

  • Patients with CNS metastases
  • 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) ≤ 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 ≤ 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
  • Patients who have received targeted therapy (e.g. sunitinib, sorafenib, pazopanib) ≤ 2 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
  • Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or ≤ 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
  • Pregnant or breast-feeding women
  • Fertile males not willing to use contraception, as stated above
  • Patients unwilling or unable to comply with the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964144


Locations
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Korea, Republic of
Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01964144     History of Changes
Other Study ID Numbers: 4-2012-0405
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Yonsei University:
thyroid cancer, dovitinib

Additional relevant MeSH terms:
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Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms