A Study Using Regorafenib as Second or Third Line Therapy in Metastatic Medullary Thyroid Cancer

  • STATUS
    Recruiting
  • End date
    Dec 10, 2023
  • participants needed
    33
  • sponsor
    Dana-Farber Cancer Institute
Updated on 10 March 2022
platelet count
renal function
cancer
measurable disease
neutrophil count
medullary thyroid carcinoma

Summary

This research study is studying a targeted therapy as a possible treatment for thyroid cancer. A targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells.

  • The name of the study intervention involved in this study is regorafenib.

Description

This is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

The FDA (the U.S. Food and Drug Administration) has approved regorafenib as a treatment for metastatic colorectal cancer and locally advanced, unresectable or metastatic gastrointestinal stromal tumor. Regorafenib has not been approved for treatment against thyroid cancer.

Regorafenib is an oral anti-tumor agent that blocks activity of a specific kind of protein involved in normal cellular functions and in pathologic processes such as tumor formation and maintenance.

Details
Condition Thyroid Cancer
Treatment Regorafenib
Clinical Study IdentifierNCT02657551
SponsorDana-Farber Cancer Institute
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure
Age ≥ 18 years
Life expectancy of at least 12 weeks (3 months)
Eastern Cooperative Oncology Group performance status of ≤1
Histologically or cytologically confirmed diagnosis of metastatic medullary thyroid cancer
Documented disease progression within 6 months prior to study registration, as defined by RECIST criteria
Must have at least 1 site of measurable disease by RECIST criteria, by version 1.1
Archival tissue block or unstained slides (from primary or metastatic site) must be available, otherwise fresh tissue biopsy sample will be collected
Any number of prior chemotherapies and targeted therapies are allowed
Patients must have received at least one prior line of targeted therapy
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements within 3 weeks prior to study registration
Total bilirubin ≤ 1.5 x the upper limits of normal (ULN)
Alanine aminotransferase (ALT) and aspartate amino-transferease (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
Alkaline phosphastase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
Serum creatinine ≤ 1.5 x the ULN
International normalized ratio (INR)/ Partial thromboplastin time (PTT) ≤ 1.5 x ULN. (Subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care. (See Section 3.3)
Platelet count > 100000 /mm3, hemoglobin (Hb) > 9 g/dL, absolute neutrophil count (ANC) 1500/mm3. Blood transfusion to meet the inclusion criteria will not be allowed
Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to study registration. Post-menopausal women (defined as
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 2 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
no menses for at least 1 year) and surgically sterilized women are not
Subject must be able to swallow and retain oral medication
required to undergo a pregnancy test. The definition of adequate contraception
will be based on the judgment of the investigator

Exclusion Criteria

Prior treatment with regorafenib
Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study
Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management
Active or clinically significant cardiac disease including
Congestive heart failure - New York Heart Association (NYHA) > Class II
Active coronary artery disease
Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Evidence or history of bleeding diathesis or coagulopathy
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment
Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before registration are allowed. All cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form)
Patients with pheochromocytoma
Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication
Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy
Ongoing infection > Grade 2 NCI-CTCAE v4.0
Symptomatic metastatic brain or meningeal tumors
Presence of a non-healing wound, or non-healing ulcer, (that is not tumor related) or bone fracture
Major surgical procedure or significant traumatic injury within 28 days before start of study medication
Other investigational treatment during or within 30 days before starting study treatment
Use of any approved tyrosine kinase inhibitors within 2 weeks or 6 half-lives of the agen, whichever is shorter, prior to receiving study drug
Prior radiation within 14 days before start of study medication.Renal failure requiring hemo-or peritoneal dialysis
Patients with seizure disorder requiring medication
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Dehydration Grade ≥1 NCI-CTCAE v4.0
History of organ allograft (including corneal transplant)
Persistent proteinuria ≥ Grade 3 NCI-CTCAE v4.0 (> 3.5 g/24 hrs, measured by urine protein: creatinine ratio on a random urine sample)
Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial
Any malabsorption condition
Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE version 4.0 Grade 2 dyspnea)
Women who are pregnant or breast-feeding
Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
Excluded therapies and medications, previous and concomitant
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment (regorafenib, other agents being investigated in combination with regorafenib)
Prior use of regorafenib
Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
Therapeutic anticoagulation with Vitamin-K antagonists (e.g., warfarin) or with heparins and heparinoids
\--- However, prophylactic anticoagulation as described below is allowed
Prophylactic doses of heparin
Use of any herbal remedy (e.g. St. John's Wort [Hypericum perforatum])
Low dose warfarin (1 mg orally, once daily) with PT-INR ≤ 1.5 x ULN is permitted. Infrequent bleeding or elevations in PT-INR have been reported in some subjects taking warfarin while on regorafenib therapy. Therefore, subjects taking concomitant warfarin should be monitored regularly for changes in PT, PT-INR or clinical bleeding episodes
Low dose aspirin (≤ 100 mg daily)
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