Phase 2
N=19
Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer
Anaplastic Thyroid Cancer · Recurrent Thyroid Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02152137 ↗Enrolled (actual)
19
Serious AEs
53.3%
Results posted
Dec 2019
Primary outcome: Primary: Confirmed Response Rate (Partial Response [PR] or Complete Response [CR]) Per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 Criteria — 13 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- efatutazone (Drug); paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Response Rate (Partial Response [PR] or Complete Response [CR]) Per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 Criteria |
13 | — |
| SECONDARY Overall Survival |
6.6 | — |
| SECONDARY Duration of Confirmed Response |
12.2; 3.2 | — |
| SECONDARY PFS Determined Based on RECIST 1.1 Criteria |
2.5 | — |
| SECONDARY Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0 |
13 | — |
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.
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) = = 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Creatinine = = 60 mL/min
- Bilirubin = = 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)
Data sourced from ClinicalTrials.gov (NCT02152137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.