WithdrawnPhase 2

Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer

Stopped: study was on hold for protocol redesign; decided to not move forward with study.

United States0Started 2015-06

Plain-language summary

This is an, open-label, protocol designed to evaluate the activity of targeted therapy in anaplastic/undifferentiated thyroid cancer. Arm A will evaluate ATC/UTC with mutations or rearrangements detected in the ALK gene. There is no effective treatment for anaplastic thyroid cancer in the locally recurrent or metastatic setting. Ceritinib will be administered to the patient until disease progression by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or discontinuation of the trial for any other reason. The primary focus of this arm of the protocol is identifying ceritinib's activity in anaplastic or undifferentiated thyroid cancer patients. Those patients with mutations identified in their ALK gene by sequencing their tumor samples, or with the established ALK abnormalities will be treated with ALK-inhibitors. These include the Ventana assay and Vysis FISH probe, and patients with tumors positive by this assay will also be considered eligible for therapy on the trial. Therapeutic Portion: ARM A: ALK Abnormality IND Ceritinib 750 mg orally daily on Day 1 Continue q4 weeks x 2 cycles Primary Endpoint: The development of progression; new recurrence or distant metastasis, as well as enlargement of an existing metastasis on radiographic imaging. Secondary Endpoints: 1. Overall response rate for patients treated with ceritinib as part of the study. 2. Death of study participant due to any cause.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically or cytologically confirmed diagnosis of anaplastic thyroid cancer or undifferentiated thyroid cancer that demonstrates mutation in the ALK gene as assessed by sequencing of the tumor specimen for Arm A. Other ALK abnormalities as detected by the approved FISH test (Abbott Molecular Inc), using Vysis breakapart probes (defined as 15% or more positive tumor cells); or the Ventana IHC test will also be seen as evidence of ALK abnormality and meeting eligibility requirement.
✓. Patients will not have any other curative therapeutic option, such as radiation or surgery.
✓. WHO performance status 0-2.
✓. Age greater then or equal to 18 years.
✓. Patients must have recovered from all toxicities related to prior anticancer therapies to ≤ Grade 2 (CTCAE v 4.03), provided that any concomitant medication is given prior to initiation of treatment with ceritinib. Exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment.
✓. Adequate organ function: the following laboratory criteria have been met:
✓. Patient must have the following laboratory values or have the following laboratory values corrected with supplements to be within normal limits at screening:
✓. Written informed consent for the protocol must be obtained prior to any screening procedures.

What they're measuring

Development of Progression

Timeframe: Radiographic Imaging Assessments at Screening and every 56 days until evidence of progression (average 7 months) or unacceptable toxicity, withdrawal of Consent, or discontinuation of the trial for any other reason.

Trial details

NCT IDNCT02289144

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01

View on ClinicalTrials.gov More Metastatic Anaplastic Thyroid Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically or cytologically confirmed diagnosis of anaplastic thyroid cancer or undifferentiated thyroid cancer that demonstrates mutation in the ALK gene as assessed by sequencing of the tumor specimen for Arm A. Other ALK abnormalities as detected by the approved FISH test (Abbott Molecular Inc), using Vysis breakapart probes (defined as 15% or more positive tumor cells); or the Ventana IHC test will also be seen as evidence of ALK abnormality and meeting eligibility requirement.
✓. Patients will not have any other curative therapeutic option, such as radiation or surgery.
✓. WHO performance status 0-2.
✓. Age greater then or equal to 18 years.
✓. Patients must have recovered from all toxicities related to prior anticancer therapies to ≤ Grade 2 (CTCAE v 4.03), provided that any concomitant medication is given prior to initiation of treatment with ceritinib. Exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment.
✓. Adequate organ function: the following laboratory criteria have been met:
✓. Patient must have the following laboratory values or have the following laboratory values corrected with supplements to be within normal limits at screening:
✓. Written informed consent for the protocol must be obtained prior to any screening procedures.

Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria