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Glossary
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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Genentech Novartis |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00738751 |
The purpose of the study is to:
Condition | Intervention | Phase |
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Lung Cancer Head and Neck Cancer |
Drug: LBH589 Drug: erlotinib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of LBH589 in Combination With Erlotinib for Advanced Aerodigestive Tract Cancers (CLBH5889CUS11T) |
Estimated Enrollment: | 44 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
12-24 patients will be enrolled in the phase I component. 10 additional patients with NSCLC and 10 additional patients with HNCA will be treated at the Phase I expansion dose.
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Drug: LBH589
One treatment cycle will be defined as a 21 day course of erlotinib with a total of 4 doses of LBH589 given biweekly on Tuesday and Friday for 1 week off and 2 weeks on (Days 9, 12, 16, and 19). Patients may continue treatment with oral LBH589 until they experience unacceptable toxicity that precludes further treatment, disease progression, and/or at the discretion of the investigator. One treatment cycle will be defined as a 21 day course of erlotinib with a total of 4 doses of LBH589 given biweekly on Tuesday and Friday for 1 week off and 2 weeks on (Days 9, 12, 16, and 19). Patients may continue treatment with oral LBH589 until they experience unacceptable toxicity that precludes further treatment, disease progression, and/or at the discretion of the investigator. |
Patients will be asked to remain on the study for a minimum of 3 months unless the study doctor decides the patient should be taken off the study or the patient withdraws from the study. Each cycle of treatment is 21 days in length and there is a 30 day follow-up after the patient receives their last dose of study drug. Scans will be repeated to see how their cancer is doing after two cycles of treatment. These scans wil be repeated every 2 cycles for the first six cycles and then every 3 cycles for as long as the patient remains on the study. The patient may continue on therapy as long as they are responding or have stable disease.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must meet the following laboratory criteria:
Exclusion Criteria:
Impaired cardiac function including any one of the following:
Contact: Jill McHale | 813-745-8384 | jill.mchale@moffitt.org |
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Leticia Tetteh 813-745-4617 leticia.tetteh@moffitt.org | |
Contact: Anne Dellaportas 813-745-4616 anne.dellaportas@moffitt.org | |
Principal Investigator: Janelle Gray, M.D. | |
Principal Investigator: Eric Haura, M.D. | |
Sub-Investigator: Soner Altiok, M.D., Ph.D. | |
Sub-Investigator: Scott Antonia, M.D. | |
Sub-Investigator: Gerald Bepler, M.D., Ph.D. | |
Sub-Investigator: Alberto Chiappori, M.D. | |
Principal Investigator: Ronald DeConti, M.D. | |
Sub-Investigator: Sharon Litschauer, ARNP | |
Sub-Investigator: Richard Lush, Ph.D. | |
Sub-Investigator: Michelle Mintz, ARNP | |
Sub-Investigator: George Simon, M.D. | |
Sub-Investigator: Tawee Tanvetyanon, M.D. | |
Sub-Investigator: Charles Williams, M.D. |
Principal Investigator: | Jhanelle Gray, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center & Research Institute ( Jhanelle Gray, M.D. ) |
Study ID Numbers: | MCC-15461, IND 102483, LBH589 |
Study First Received: | August 18, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00738751 |
Health Authority: | United States: Food and Drug Administration |
NSCLC Metastatic erlotinib |
aerodigestive tract cancers non-small cell lung cancer H&N cancer |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Head and Neck Neoplasms Carcinoma, Non-Small-Cell Lung |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |