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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2013 |
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Main ID: |
NCT01013597 |
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Date of registration:
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28/10/2009 |
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Primary sponsor: |
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Public title:
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Trial of LBH589 in Metastatic Thyroid Cancer
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Scientific title:
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A Phase II Trial of LBH589 in Patients With Metastatic Medullary Thyroid Cancer and Radioactive Iodine Resistant Differentiated Thyroid Cancer |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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33 |
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Recruitment status: |
Suspended |
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URL:
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http://clinicaltrials.gov/show/NCT01013597 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Anne Traynor, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Wisconsin, Madison |
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Key inclusion & exclusion criteria
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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 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Thyroid Carcinoma
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Intervention(s)
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Drug: LBH589
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Primary Outcome(s)
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Tumor response rate to LBH589.
[Time Frame: Every 8 weeks.]
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Secondary Outcome(s)
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Impact of LBH589 on tumor markers for thyroid cancer
[Time Frame: Yearly]
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Overall survival
[Time Frame: Yearly]
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Protein expression patterns of Notch1 in thyroid tissue samples.
[Time Frame: End of study]
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Time to progression of thyroid cancer
[Time Frame: Yearly]
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Tolerability of LBH589
[Time Frame: Every 4 weeks.]
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Toxicity of LBH589
[Time Frame: Every 4 weeks.]
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Secondary ID(s)
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CO 08322
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H-2009-0173
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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