Clinical trial NCT03002623
Conditions: Thyroid Neoplasms Poorly Differentiated and Undifferentiated Thyroid Cancer Differentiated Thyroid Cancer
Keywords: Dual Inhibitor of HDAC and P13K Signaling HDAC2 EGFR/RAS/RAF/MEK/ERK Signaling Pathway Inhibition
Sponsor: National Cancer Institute (NCI)
Start date: 2016-12-22; Completion date: 2018-02-12
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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....

Detailed description:
Background:

* There are no standard or effective systemic therapies for metastatic or locally advanced poorly differentiated and undifferentiated thyroid cancer.
* Poorly differentiated and undifferentiated thyroid cancer are aggressive, with high mortality.
* CUDC-907 is a first-in-class dual inhibitor of histone deacetylase (HDAC) and PI3K signaling.
* Approximately 80% of poorly differentiated and undifferentiated thyroid cancers have driver mutations in the PI3K/AKT pathway or activation of the pathway.
* HDAC2 is upregulated in poorly differentiated and undifferentiated thyroid cancer, and aggressive variants of differentiated thyroid cancer, and CUDC-907 treatment reduces HDAC2 levels in thyroid cancer cells.
* CUDC-907 inhibits thyroid cancer cell growth, invasion and migration in vitro.
* In addition to inhibiting the PI3K/AKT signaling pathway, CUDC-907 inhibits the EGFR/RAS/RAF/MEK/ERK signaling pathway, which is also activated in poorly differentiated and undifferentiated thyroid cancer.
* CUDC-907 inhibits growth and metastases in a mouse model of metastatic thyroid cancer.
* We hypothesize that CUDC-907 will cause cancer regression in patients with metastatic and locally advanced poorly differentiated and undifferentiated thyroid cancer, and aggressive variants of differentiated thyroid cancer.

Objective:

-To determine response to CUDC-907 treatment by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with locally advanced and metastatic poorly differentiated and undifferentiated thyroid cancer, and aggressive variants of differentiated thyroid cancer.

Eligibility:

* Age greater than or equal to 18 years
* Thyroid cancer that is refractory to or relapsed after standard treatment.
* Aggressive thyroid cancer confirmed on histology or cytologic analysis.
* Measurable disease.
* Last dose of chemotherapy or last radiotherapy treatment more than 4 weeks prior to starting treatment with this protocol, except for subjects with anaplastic/undifferentiated thyroid cancer who may enroll immediately after discontinuation of previous therapy.

Design:

* Open label, phase II trial to determine response to CUDC-907 treatment.
* Patients will be given 60 mg of CUDC-907 orally for 5 consecutive days followed by 2 days off (5/2 schedule).
* One cycle is 21 days. Patients may continue on treatment if there is no disease progression.
* Initial anatomic and functional imaging will be performed at enrollment and after 2 cycles of treatment. Thereafter, anatomic imaging will be performed every two cycles of treatment.

Arms: arm 1: CUDC-907 for thyroid cancer
Interventions: intervention 1: CUDC-907
Intervention descriptions: intervention 1: 60 mg (2 capsules of 30 mg capsules) will be given orally once a day 5 days on and 2 days off.

Protocol documents:
Prot_SAP_ICF_000.pdf: 
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