ClinicalTrials.gov
ClinicalTrials.gov Menu

Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02152137
Recruitment Status : Recruiting
First Posted : June 2, 2014
Last Update Posted : September 6, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

May 29, 2014
June 2, 2014
September 6, 2018
September 2014
July 2019   (Final data collection date for primary outcome measure)
Confirmed response rate (partial response [PR] or complete response [CR]) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria [ Time Frame: Up to 5 years ]
Overall Survival [ Time Frame: Up to 5 years post-randomization ]
Complete list of historical versions of study NCT02152137 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: Time from study entry to death from any cause, assessed up to 12 months of follow-up ]
  • Duration of confirmed response [ Time Frame: The time from the first documented date of confirmed response (CR or PR) to date at which progression is first documented, assessed up to 5 years ]
  • PFS determined based on RECIST 1.1 criteria [ Time Frame: The time from study entry to the first of either disease progression or death from any cause, assessed up to 5 years ]
  • Incidence of adverse events summarized using CTCAE version 4.0 [ Time Frame: Up to 5 years ]
  • Confirmed response rate [ Time Frame: Up to 5 years post-randomization ]
  • Progression Free Survival [ Time Frame: Up to 5 years post-randomization ]
  • Incidence of adverse events, graded according to Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 5 years post-randomization ]
Not Provided
Not Provided
 
Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer
A Phase 2 Study of Efatutazone, an Oral PPAR Agonist, In Combination With Paclitaxel in Patients With Advanced Anaplastic Thyroid Cancer
This phase II trial studies how well inolitazone dihydrochloride (efatutazone dihydrochloride) and paclitaxel work in treating patients with anaplastic thyroid cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Drugs used in chemotherapy, such as efatutazone dihydrochloride and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

PRIMARY OBJECTIVES:

I. To determine if the combination of paclitaxel and efatutazone (efatutazone dihydrochloride) improves the confirmed response rate in patients with advanced anaplastic thyroid cancer.

SECONDARY OBJECTIVES:

I. To estimate the overall survival (OS), duration of response, progression-free survival (PFS), and adverse event rates for the combination of paclitaxel and efatutazone.

TERTIARY OBJECTIVES:

I. The association of biomarkers with clinical outcome data will be assessed in an exploratory translational analysis.

OUTLINE:

Patients receive paclitaxel intravenously (IV) over 3 hours on day 1 and efatutazone dihydrochloride orally (PO) twice daily (BID) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up within 28 days, every 8 weeks until disease progression, and then every 6 months for 5 years.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Anaplastic Thyroid Cancer
  • Recurrent Thyroid Cancer
  • Drug: efatutazone
    Given PO
    Other Name: CS-7017
  • Drug: paclitaxel
    Given IV
    Other Name: Taxol
Experimental: efatutazone dihydrochloride, paclitaxel
Patients receive paclitaxel IV over 3 hours on day 1 and efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: efatutazone
  • Drug: paclitaxel
Cabanillas ME, McFadden DG, Durante C. Thyroid cancer. Lancet. 2016 Dec 3;388(10061):2783-2795. doi: 10.1016/S0140-6736(16)30172-6. Epub 2016 May 27. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
50
Not Provided
July 2019   (Final data collection date for primary outcome measure)
  • 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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Robert Smallridge, MD 904 953-2392
United States
 
 
NCT02152137
A091305
U10CA031946 ( U.S. NIH Grant/Contract )
U10CA180821 ( U.S. NIH Grant/Contract )
NCI-2014-00686 ( Registry Identifier: NCI Clinical Trials Reporting Office )
Yes
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)
  • Daiichi Sankyo, Inc.
Study Chair: Robert Smallridge, M.D. Mayo Clinic
Alliance for Clinical Trials in Oncology
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP