Safety and Efficacy of Sorafenib in Patients With Advanced Thyroid Cancer: a Phase II Clinical Study

NCT02084732 | Completed Phase 2 DMC

• 1 other identifier: 410-30610-258
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Differentiated thyroid cancer includes papillary, follicular, Hurthle cell, and C-cell/medullary carcinoma. Even though incidence is relatively low (1% of all neoplasms), a rise in this disease has been recorded in the country (The Atlas of Cancer Mortality in Colombia, 2010). Although this disease has a low rate of attributable mortality, the costs arising from treatment, monitoring, and disabilities among affected patients and their families are high for the health system. The therapeutic approach to differentiated thyroid cancer once it starts progressing is limited; there are no truly favorable treatment options for patients with advanced thyroid cancer: available options include surgery, radiotherapy, and radioactive iodine therapy. Molecular biology now allows the identification of the effects of mutations and alterations in the proteins that participate in cell signaling which account for dedifferentiation, invasiveness, and the progression of neoplastic cells. VEGFR (vascular endothelial growth factor receptor) is one of the main molecules to be addressed by targeted molecular therapy. Its increased expression in differentiated thyroid cancer has been demonstrated and has been associated with increased growth, invasiveness, and shorter recurrence-free survival. Different agents are effective against this tyrosine kinase receptor; nevertheless, taking into account that it is not solely responsible for tumor progression, according to clinical study results, it is more reasonable to use non-selective tyrosine kinase inhibitors such as sorafenib and motesanib. These inhibitors have already been tested in phase II studies. Results from recent phase II research studies using these emerging treatment options have shown important effects in the therapeutic approach to other solid neoplasms. Information about the safety of this type of treatment is limited; a need for information regarding the use of new therapeutic approaches in Colombia is one of the contributions that the National Institute of Cancer can make to the country through this study.

Conditions

Thyroid Cancer

Keywords

Sorafenib, thyroid neoplasms, salicylic acid

Outcome Measures

Primary Outcomes (1)

• Describe the clinical activity and safety profile of sorafenib in the treatment of patients with advanced thyroid cancer (metastatic or recurrent) among a selected group of patients refractory to or ineligible to radioactive iodine (RAI) therapy

  3 years

Secondary Outcomes (2)

• Summarize the progression-free survival (PFS) of patients with advanced thyroid cancer (metastatic or recurrent) treated with sorafenib

  two years

• Describe the occurrence and type of adverse events associated with sorafenib use in advanced thyroid cancer (metastatic or recurrent) patients included

  two years

Study Arms (1)

Sorafenib

EXPERIMENTAL

drug

Drug: Sorafenib

Interventions

Sorafenib DRUG

drug

Also known as: nexavar

Sorafenib

Eligibility Criteria

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

* Older than 18 years. * Confirmed histological diagnosis of differentiated thyroid cancer, whether metastatic or unresectable, for whom conventional curative or palliative therapeutic options do not exist or are not effective. It includes patients with lesions visible in images, that have no uptake at therapeutic doses of iodine, or patients with iodine avid lesions, that keep progressing after therapeutic doses (greater than 100 mCi). Also comprises patients with persistent local disease progression not amenable to surgical management or radiation therapy management. * The time that has passed since the last treatment until inclusion must of at least six (6) months. * There must be at least 1 lesion that can be adequately measured according to the RECIST (v.1.1) criteria \[See Appendix 1\]. * Neck or lung lesions, surgery declared unresectable. * Patients must have a ECOG score less than 2 and life expectancy greater than 3 months. * Adequate bone marrow, liver and renal functions defined by the following laboratory parameters, taken no more than 7 days after consent signing: white blood cell count, \> 3,000/uL; absolute neutrophil count, \> 1,500/mm3; platelets, \> 100,000/mm3; hemoglobin, 9 g/dl; serum creatinine, \< 1.5 times the upper limit of normal (ULN) or creatinine clearance in urine for 24 hours \> 75 cc/min; total serum bilirubin, \< 1.5 times the ULN; glutamic oxaloacetic transaminase (SGOT), \< 1.5 times the ULN; serium alkaline phosphatase, \< 1.5 times the ULN; prothrombin time (PT-INR) and partial thromboplastin time (PTT), \< 1.5 times the ULN. * The patient must be physically, intellectually, and emotionally able to take the oral medicine. * Patient must not be a candidate for surgery or radiotherapy with curative intent * Women of childbearing potential should have a negative serum pregnancy test performed within 7 days prior to start of treatment. Post-menopausal women (at least one year with no menstruation) and surgically sterilized women do not require pregnancy tests. * Women and also men of childbearing potential should agree to use adequate contraceptive methods * Significant medical conditions including an uncontrolled hypertension (systolic blood blood pressure \>150 mmHg or diastolic blood pressure \> 90mmHg) * Significant Hemorrhage or bleeding events, CTCAE grade 3 or higher, within 12 weeks of randomization. arterial or venous thrombotic or embolic events within the past 6 months (including cerebrovascular accidents and transient ischemic attacks, deep vein thrombosis, pulmonary embolism and arterial thrombosis). * Recent major surgery or open biopsy procedure (within 4 weeks of study entry) * Bone lesions will be excluded, by its susceptibility to radiotherapy and bisphosphonates management. * Wounds, ulcers or bone fractures that are non healing * Pregnancy or lactation. * A personal history of a second neoplasm with the exception of squamous-cell or basal-cell skin cancer that is suitably treated, in situ cervical cancer, or any other previously treated cancer when one has stayed free of disease for 5 years or more. * Prior use (4 weeks before admittance to the study) of chemotherapy or cancer immunotherapy. * Prior use of of tyrosine kinase inhibitors or other targets agents, or monoclonal antibodies that target VEGF or VEGF receptors. * Known or suspected allergy or hypersensitivity to sorafenib * Having received radiotherapy in the 4 weeks preceding admittance to the study. * Any condition according to the judgment of the treating physician that could jeopardize the patient's safety or compliance to the study. * All patients that are admitted to the study must voluntarily consent to their participation and the same must be recorded in a written informed consent form.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Instituto Nacional de Cancerologia, Columbia: lead

Study Sites (1)

Instituto Nacional de Cancerología

Bogotá, Cundinamarca, 00000, Colombia

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Luis F Fierro, Md

  Instituto Nacional de Cancerologia de Mexico

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 12, 2014
• Study Start: October 1, 2013
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

CO (1)