Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
- Registration Number
- NCT00425555
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 139
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Previously treated with oral bexarotene Panobinostat Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). No prior oral bexarotene treatment Panobinostat Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5).
- Primary Outcome Measures
Name Time Method Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT) Baseline up to 6 Months of Follow up Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL (Olsen et al 2007).
Responses in the skin based on SWAT are defined as:
* Complete Response (CR): no evidence of skin disease
* Partial Response (PR): ≥ 50% decrease of the modified SWAT score compared with baseline
* Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score
* Progressive Disease (PD): ≥ 25% increase in the modified SWAT score compared with baseline.
- Secondary Outcome Measures
Name Time Method The Overall Response Rate Using mSWAT Skin Score Baseline up to Cycle 12, an average of 12 months Estimate of the response rate of participants with resistant cutaneous T-cell lymphoma (CTCL) treated with Panobinostat using the mSWAT skin scores and 95% CI will be analyzed.
Time to Response for Responders Baseline up to Cycle 12, an average of 12 months Time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival.
Progression-free Survival (PFS) Baseline up to Cycle 12, an average of 12 months PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment
Skindex-29 Measurements of Average Sub-scores for Functioning From Baseline up to Cycle 12 Baseline up to Cycle 12, an average of 12 months Skindex-29 was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess functioning scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed.
Duration of Response (DOS) Baseline up to Cycle 12, an average of 12 months Duration of response and time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival.
Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12 Baseline up to Cycle 12, an average of 12 months Skin index measurement (Skindex-29) was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess emotions scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed.
Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12 Baseline up to Cycle 12, an average of 12 months Skindex-29 was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess physical symptoms scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed.
Maximum Plasma Concentration (Cmax) of Panobinostat Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations. It will be obtained from the Cmax parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Cmax will be missing for that subject. Cmax will be reported in units of ng/mL.
Time to Peak Concentration (Tmax) of Panobinostat Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 Tmax is defined as the time at which the Cmax occurs. It will be obtained from the Tmax parameter calculated by WinNonlin®. If there is no measurable Cmax in the subject's PK profile, then Tmax will be missing for that subject. Tmax will be reported in units of h.
Area Under the Plasma Concentration AUC0-24, AUC0-48 and AUC 0-infinity of Panobinostat Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 AUC is defined as the area under concentration-time curve as a measure of drug exposure. The area under the plasma concentration-time curve from time zero to 24 hours. The area under the plasma concentration-time curve from time zero to 48 hours. AUC (0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.
Time of Clast (Tlast) of Panobinostat Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 Time of Clast (Tlast) will be obtained from the Tlast parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Tlast will be missing for that participants. Tlast will be reported in units of h.
Last Observed Plasma Concentration (Clast) of Panobinostat Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8 Clast is defined as the Last observed (quantifiable) plasma concentration (Clast), in units of ng/mL. Blood samples were collected to assess Clast.
Trial Locations
- Locations (17)
Novartis Investigative Site
🇨🇭Zürich, Switzerland
Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)
🇺🇸Atlanta, Georgia, United States
Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia
🇺🇸Augusta, Georgia, United States
University of Pittsburgh Medical Center Department of Dermatology
🇺🇸Pittsburgh, Pennsylvania, United States
University of Michigan Health System Michigan HouseClinTrialsOffice
🇺🇸Ann Arbor, Michigan, United States
University Dermatology Consultants
🇺🇸Cincinnati, Ohio, United States
Dana Farber Cancer Institute Deptof DanaFarberCancerInst(3)
🇺🇸Boston, Massachusetts, United States
University of California at Los Angeles Dept. of Hematology-Oncology
🇺🇸Los Angeles, California, United States
University of Alabama at Birmingham/ Kirklin Clinic Kirklin Clinic
🇺🇸Birmingham, Alabama, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Indiana University Dept. of IU Cancer Center
🇺🇸Indianapolis, Indiana, United States
Oregon Health & Science University Dept. of OHSU Cancer Institute
🇺🇸Portland, Oregon, United States
MD Anderson Cancer Center/University of Texas StudyCoordinator:CLBH589B2201
🇺🇸Houston, Texas, United States
Wake Forest University Baptist Medical Center OutpatientCmprehensivCancerCtr
🇺🇸Winston-Salem, North Carolina, United States
Florida Academic Dermatology Center
🇺🇸Miami, Florida, United States
NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept. of NorthwesterUMed
🇺🇸Chicago, Illinois, United States
Boston Medical Center StudyCoordinator:CLBH589B2201
🇺🇸Boston, Massachusetts, United States