Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer | NCT02152137 | Trialant

Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer | NCT02152137 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Patients must have histologically or cytologically diagnosed advanced anaplastic thyroid cancer (ATC)

Patients must have measurable disease

Patients must have either metastatic (stage IVC) or locally advanced unresectable disease (stage IVB)

Patients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, grade 1

There is no limit to the number of prior lines of treatment a patient has received

No treatment with chemotherapy, radiation therapy, immunotherapy, biological therapy, hormonal therapy, or other thiazolidinediones (TZDs) =< 21 days before study registration

No prior taxane therapy =< 6 months, except as a radiosensitizer

No history of the following:

Class III or IV congestive heart failure (CHF)

Grade 3 or 4 thromboembolic event =< 6 months

Pericardial effusion =< 12 months (any grade)

Pericardial involvement with tumor

Grade 2 or higher pleural effusion =< 6 months

No current symptomatic, untreated, or uncontrolled brain metastases present

No major surgery =< 14 days prior to registration

No grade 2 or higher neuropathy

No known history of severe hypersensitivity reactions to any of the components of efatutazone or paclitaxel formulations

Not pregnant and not nursing; women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required

Patients with diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligible

Patients with known hypersensitivity to any TZD oral agents are not eligible

Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Absolute neutrophil count (ANC) >= 1,500/mm^3

Platelet count >= 100,000/mm^3

Creatinine =< 1.5 x upper limit of normal (ULN) mg/dL OR calculated (calc.) creatinine clearance >= 60 mL/min

Bilirubin =< 1.5 x ULN

Aspartate aminotransferase (AST) =< 2.5 x ULN

Although they will not be considered formal eligibility (exclusion) criteria, physicians should recognize that the following may seriously increase the risk to the patient entering this protocol:

Psychiatric illness which would prevent the patient from giving informed consent

Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient

Patients with a "currently active" second malignancy other than non-melanoma skin cancers; patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for >= 3 years; there is an exception for patients with a history of well differentiated thyroid cancer that has progressed to anaplastic thyroid cancer

Patients who cannot swallow oral formulations of the agent(s)

Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study ; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)

Efatutazone is metabolized by cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5), and inhibits CYP2C8, 2C9, 2C19, and 3A4, and is a substrate of P-glycoprotein (PgP) and breast cancer resistance protein (BCRP)