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CUDC-907 Treatment in People With Metastatic and Locally Advanced Thyroid Cancer

NCT03002623 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2018-12-21

Study results available
· View outcomes & findings →

Summary

Background:

The thyroid is a gland at the base of the throat. Thyroid cancer is a disease that people get when abnormal cells begin to grow in this gland. Researchers believe a new drug called CUDC-907 may be able to help people with thyroid cancer that has spread or has gotten worse.

Objective:

To see if CUDC-907 will shrink tumors in people with advanced thyroid cancer.

Eligibility:

People at least 18 years old who have been diagnosed with locally advanced and metastatic thyroid cancer.

Design:

Participants will be screened with:

Medical history

Physical exam

Blood and urine tests

Electrocardiogram (ECG) heart test.

Review of their symptoms and how they perform normal activities

A scan will be performed. Some will have a computed tomographic scan (CT) that takes pictures of the body using a small amount of radiation. Some will have magnetic resonance imaging (MRI) that uses a magnetic field to take pictures.

Bone scan (some participants)

Fludeoxyglucose (FDG) positron emission tomography (PET) scan to produce a tumor image.

A sample of their tumor from a previous surgery. They may have a biopsy of their tumor if a tumor sample is not available from a previous surgery.

Participants will be given CUDC-907 in tablet form. They will take it by mouth once a day for 5 days, then take 2 days off, each week.

While taking the study drug, participants will have study visits that repeat the screening tests.

After they stop treatment, participants will have 3 follow-up visits over a year. They will repeat some tests. Then participants will be contacted by phone or e-mail every 6 months....

Conditions

  • Thyroid Neoplasms
  • Poorly Differentiated and Undifferentiated Thyroid Cancer
  • Differentiated Thyroid Cancer

Interventions

DRUG

CUDC-907

60 mg (2 capsules of 30 mg capsules) will be given orally once a day 5 days on and 2 days off.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Naris Nilubol, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-22
Primary Completion
2018-02-12
Completion
2018-02-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03002623 on ClinicalTrials.gov