Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-25 @ 2:56 AM
NCT ID:
NCT00918333
Brief Summary:
This phase I/II trial studies the side effects and best dose of panobinostat and everolimus when given together and to see how well they work in treating patients with multiple myeloma, non-Hodgkin lymphoma, or Hodgkin lymphoma that has come back. Panobinostat and everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated doses (MTD) of LBH589 (panobinostat) and RAD001 (everolimus) when used in combination in patients with myeloma or lymphoma. (Phase I) II. To evaluate the therapeutic activity of the combination of LBH589 with RAD001 in patients with relapsed or refractory lymphoma. (Arm A, phase II) III. To evaluate the therapeutic activity of the combination of LBH589 with RAD001 in patients with relapsed or refractory multiple myeloma. (Arm B, phase II)
SECONDARY OBJECTIVES:
I. To describe the toxicities associated with the combination of LBH589 with RAD001. (Phase I) II. To further describe the toxicities associated with the combination of LBH589 with RAD001 in each arm independently. (Phase II) III. To evaluate overall survival, progression-free survival, and duration of response in each arm independently. (Phase II)
TERTIARY OBJECTIVES:
I. To evaluate the pharmacokinetic interaction of LBH589 and RAD001. II. To assess the correlation between clinical (toxicity and/or tumor response or activity) effects with the pharmacologic (pharmacokinetic/pharmacodynamic) parameters, and/or biologic (correlative laboratory) results.
OUTLINE: This is a phase I, dose-escalation study of panobinostat and everolimus followed by a phase II study. (dose-escalation closed to accrual as of April 6, 2011)
Patients receive panobinostat orally (PO) once daily (QD) or on days 1, 3, 5, 15, 17, and 19 and everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 2 years.
Study:
NCT00918333
Study Brief:
Protocol Section:
NCT00918333