Trial of LBH589 in Metastatic Thyroid Cancer

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Brief Title

Trial of LBH589 in Metastatic Thyroid Cancer

Official Title

A Phase II Trial of LBH589 in Patients With Metastatic Medullary Thyroid Cancer and Radioactive Iodine Resistant Differentiated Thyroid Cancer

Brief Summary

      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.

Detailed Description

      Medullary thyroid cancer (MTC) is a neuroendocrine tumor and accounts for 3-5% of cases of
      thyroid cancer. The majority of patients with MTC do not present with early stage disease.
      Differentiated thyroid cancer (DTC) accounts for >90% of all thyroid cancers. In a sub-set of
      patients, thyroid cells become resistant to I-131 radioiodine therapy and subsequently
      develop distant metastases. In both MTC and DTC, systemic chemotherapy for metastatic disease
      is largely ineffective.

      LBH589 is a histone deacetylase (HDAC) with recently demonstrated activity to inhibit the
      Notch1 signaling pathway in MTC cancer cells and suppress tumor cell proliferation in DTC
      cancer cells. This clinical trial will evaluate the tumor response rate of LBH589 in patients
      with metastatic MTC or radioactive iodine resistant DTC.

Study Phase

Phase 2

Study Type


Primary Outcome

Tumor Response Rate to LBH589.

Secondary Outcome

 Protein Expression Patterns of Notch1 in Thyroid Tissue Samples.


Thyroid Carcinoma



Study Arms / Comparison Groups



* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

January 2010

Completion Date

February 2016

Primary Completion Date

August 2013

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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

          -  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

          -  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




18 Years - N/A

Accepts Healthy Volunteers



Anne Traynor, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

University of Wisconsin, Madison


 Novartis Pharmaceuticals

Study Sponsor

Anne Traynor, M.D., Principal Investigator, University of Wisconsin, Madison

Verification Date

March 2017