- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01964144
An Open-label, Multicenter, Phase II Study of Dovitinib in Advanced Thyroid Cancer
November 26, 2014 updated by: Yonsei University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 120-752
- Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Dovitinib arm
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Dovitinib 500mg (5 capsules x 100 mg/day) for 5 consecutive days and 2 days rest
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: 1 month after treatment
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Lesions measurements are performed by CT or MRI scan, evaluation by RECIST criteria v1.1
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1 month after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
October 9, 2013
First Submitted That Met QC Criteria
October 14, 2013
First Posted (Estimate)
October 17, 2013
Study Record Updates
Last Update Posted (Estimate)
December 2, 2014
Last Update Submitted That Met QC Criteria
November 26, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2012-0405
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thyroid Cancer
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National Cancer Institute (NCI)TerminatedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Anaplastic Thyroid Cancer | Stage III Follicular Thyroid Cancer | Stage III Papillary Thyroid CancerUnited States
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University of WashingtonNational Cancer Institute (NCI); GlaxoSmithKline; National Comprehensive Cancer...CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
-
University of PennsylvaniaCompletedMetastatic Medullary Thyroid Cancer | Metastatic Differentiated Thyroid Cancer | Metastatic Anaplastic Thyroid Cancer | Metastatic Poorly Differentiated Thyroid CancerUnited States
-
Massachusetts General HospitalEli Lilly and CompanyRecruitingThyroid Carcinoma | Thyroid Cancer | Papillary Thyroid Cancer | Metastatic Thyroid Cancer | Follicular Thyroid Cancer | Unresectable Thyroid Gland CarcinomaUnited States
-
Children's Hospital of PhiladelphiaBayerRecruitingCancer | Pediatric Cancer | Differentiated Thyroid Cancer | Cancer, ThyroidUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Thyroid Gland Medullary Carcinoma | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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National Cancer Institute (NCI)CompletedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage II Follicular Thyroid Cancer | Stage II Papillary Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteTerminatedThyroid Cancer, Medullary | Thyroid Cancer | Papillary Thyroid Cancer | Differentiated Thyroid Cancer | Poorly Differentiated Thyroid Gland Carcinoma | Follicular Thyroid CancerUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States
Clinical Trials on Dovitinib
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Novartis PharmaceuticalsCompletedNeoplasms | Cancer | TumorsUnited States
-
Abramson Cancer Center of the University of PennsylvaniaCompletedUnresectable Paraganglioma | Recurrent Pheochromocytoma | Advanced Metastatic Paraganglioma | Advanced Metastatic Pheochromocytoma | Recurrent Paraganglioma | Unresectable PheochromocytomaUnited States
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Samsung Medical CenterUnknownSquamous NSCLCKorea, Republic of
-
Korean Cancer Study GroupCompletedHormone Refractory Prostate CancerKorea, Republic of
-
Novartis PharmaceuticalsCompletedTumor Pathway Activations Inhibited by DovitinibUnited States
-
Novartis PharmaceuticalsCompletedEndometrial Cancer | VEGF | Solid Tumors and Advanced Endometrial Cancer | Second-line TreatmentItaly, United Kingdom, Spain, Brazil, United States, Korea, Republic of, New Zealand
-
Auckland District Health BoardNovartis; University of Auckland, New Zealand; IGENZ, Ltd., AucklandUnknownClear Cell Renal Cell CarcinomaNew Zealand
-
Novartis PharmaceuticalsCompletedMetastatic Breast CancerUnited States, Canada, Finland, France, Italy, Spain, Taiwan, United Kingdom
-
M.D. Anderson Cancer CenterNovartisTerminated
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Novartis PharmaceuticalsCompletedAdvanced Solid Tumors | Excluding Breast CancerUnited States