NCT02152137|CompletedPhase 2ResultsDMC

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

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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4 other identifiers

A091305U10CA031946U10CA180821NCI-2014-00686

Study Type

interventional

Target

Locations

1 country

Sites

253

Timeline

RegisteredJun 2014

StartedDec 2014

CompletionApr 2023

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Dec 2014

Longer than P75 for phase_2

Geographic Reach

1 country

253 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.3 years study duration

First Submitted

Initial submission to the registry

May 29, 2014

Completed

4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed

7 months until next milestone

Study Start

First participant enrolled

December 30, 2014

Completed

4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2019

Completed

10 months until next milestone

Results Posted

Study results publicly available

December 27, 2019

Completed

3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed

Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

4.2 years

First QC Date

May 29, 2014

Results QC Date

December 11, 2019

Last Update Submit

January 14, 2025

Conditions

Anaplastic Thyroid Cancer Recurrent Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

Confirmed Response Rate (Partial Response [PR] or Complete Response [CR]) Per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 Criteria
The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
Up to 24 weeks

Secondary Outcomes (4)

Overall Survival
Time from study entry to death from any cause, assessed up to 5 years
Duration of Confirmed Response
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
The time from study entry to the first of either disease progression or death from any cause, assessed up to 5 years
Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0
Up to 5 years

Study Arms (1)

efatutazone dihydrochloride, paclitaxel

EXPERIMENTAL

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.

Drug: efatutazoneDrug: paclitaxel

Interventions

efatutazoneDRUG

Given PO

Also known as: CS-7017

efatutazone dihydrochloride, paclitaxel

paclitaxelDRUG

Given IV

Also known as: Taxol

efatutazone dihydrochloride, paclitaxel

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

* 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)

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

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator
Daiichi Sankyocollaborator

Study Sites (253)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC