Trial of LBH589 in Metastatic Thyroid Cancer

Completed · Phase 2

Conditions studied: Thyroid Carcinoma

In brief

The purpose of this study is to evaluate the tumor response rate in patients with metastatic medullary thyroid cancer (MTC) or radioiodine resistant differentiated thyroid cancer (DTC) after receiving treatment with LBH589 20 mg by mouth, three times weekly. Time to progression, overall survival, toxicity, tolerability, and Notch1 protein expression patterns will also be evaluated.

Key facts

Study ID

NCT01013597

Run by

University of Wisconsin, Madison

People needed

13

Starts

2010-01-01

Expected to finish

2016-02-01

Last updated by the study team

2019-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed metastatic medullary or differentiated thyroid cancer. Diagnosis must be confirmed at University of Wisconsin
• Patients must have measurable disease as defined by RECIST.
• At least 3 weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration
• No concurrent chemotherapy or radiation therapy
• ECOG Performance Status of ≤ 2
• Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
• Adequate bone marrow, kidney, liver function
• Left ventricular ejection fraction ≥ the lower limit of the institutional normal
• Those with differentiated thyroid cancer must have radioactive iodine resistant disease, defined by failure to incorporate 131-Iodine after therapy, FDG-avidity on a PET scan, or progression of measurable disease after 131-Iodine therapy or an allergy to radioactive iodine
• Hypertension must be well controlled (to less than 150/90 mmHg) on a stable regimen of anti-hypertensive therapy

You may not qualify if…

• Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer
• Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first LBH589 treatment
• Impaired cardiac function
• Concomitant use of drugs with a risk of causing torsades de pointes
• Patients with unresolved diarrhea > CTCAE grade 1
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
• Other concurrent severe and/or uncontrolled medical conditions
• Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not willing to use a double barrier method of contraception during the study and 3 months after last study drug administration. Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of oral LBH589.
• Male patients whose sexual partners are WOCBP not using a double method of contraception during the study and 3 months after the end of treatment
• Patients with a history of another primary malignancy that, in the opinion of the investigator, would interfere with the assessment of the primary endpoints of the study
• Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C
• Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent

Where it is running

• St. Vincent Regional Cancer Center CCOP — Green Bay, Wisconsin, United States
• University of Wisconsin - Madison — Madison, Wisconsin, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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