Trial of LBH589 in Metastatic Thyroid Cancer

NCT01013597 | Completed Phase 2 Results DMC

• 5 other identifiers: H-2009-0173CO08322NCI-2011-00715A534260SMPH\MEDICINE\HEM-ONC
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

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.

Conditions

Thyroid Carcinoma

Keywords

thyroid; medullary; differentiated; radioiodine-resistant; LBH589; panobinostat

Outcome Measures

Primary Outcomes (1)

• Tumor Response Rate to LBH589.

  per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.0) for target lesions and assessed by CT/MRI: "Response" includes Complete Response (CR, disappearance of all target lesions), or Partial Response (PR, \>=30% decrease in the sum of the longest diameter of target lesions). "No Response" includes Stable Disease (SD, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease), and Progressive Disease (PD, at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).)

  Every 8 weeks.

Secondary Outcomes (6)

• Protein Expression Patterns of Notch1 in Thyroid Tissue Samples.

  End of study

• Time to Progression of Thyroid Cancer

  Every 3 months until progression up to 5 years

• Overall Survival

  Every 3 months up to 5 years

• Impact of LBH589 on Tumor Markers for Thyroid Cancer

  Baseline and end of treatment, up to 1 year

• Toxicity of LBH589

  Every 4 weeks, up to 5 years

Study Arms (1)

LBH589

EXPERIMENTAL

Drug: LBH589

Interventions

LBH589 DRUG

LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.

Also known as: panobinostat

LBH589

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (3)

St. Vincent Regional Cancer Center CCOP

Green Bay, Wisconsin, 54301, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Diseases

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Abigail Mapes, Thoracic Oncology Research Program Manager
• Organization: University of Wisconsin Carbone Cancer Center

acmapes@medicine.wisc.edu

608-262-8158

Study Officials

• Anne Traynor, M.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: November 13, 2009
• Study Start: January 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: February 1, 2016
• Last Updated: November 29, 2019
• Results First Posted: July 11, 2016

Record last verified: 2017-03

Locations

US (3)