Trial Outcomes & Findings for Trial of LBH589 in Metastatic Thyroid Cancer (NCT NCT01013597)
NCT ID: NCT01013597
Last Updated: 2019-11-29
Results Overview
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).)
COMPLETED
PHASE2
13 participants
Every 8 weeks.
2019-11-29
Participant Flow
Participant milestones
| Measure |
LBH589
LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
LBH589
LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Trial of LBH589 in Metastatic Thyroid Cancer
Baseline characteristics by cohort
| Measure |
LBH589
n=13 Participants
LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
|
|---|---|
|
Age, Customized
30-39 years
|
1 participants
n=93 Participants
|
|
Age, Customized
40-49 years
|
2 participants
n=93 Participants
|
|
Age, Customized
50-59 years
|
2 participants
n=93 Participants
|
|
Age, Customized
60-69 years
|
6 participants
n=93 Participants
|
|
Age, Customized
70-79 years
|
2 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Every 8 weeks.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).)
Outcome measures
| Measure |
LBH589
n=13 Participants
LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
|
|---|---|
|
Tumor Response Rate to LBH589.
No response
|
13 participants
|
|
Tumor Response Rate to LBH589.
Response
|
0 participants
|
SECONDARY outcome
Timeframe: End of studyPopulation: Notch1 protein expression was not measured due to lack of efficiency of study intervention
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 3 months until progression up to 5 yearsProgression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Time to progression is defined as the number of days from the day of first LBH589 administration to the day the patient experienced an event of disease progression or death, whichever came first. Progression was assessed every 3 months until death or up to 5 years, whichever occurred first.
Outcome measures
| Measure |
LBH589
n=13 Participants
LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
|
|---|---|
|
Time to Progression of Thyroid Cancer
|
3.6 months
Interval 1.8 to 5.8
|
SECONDARY outcome
Timeframe: Every 3 months up to 5 yearsFor a given patient, overall survival (OS) is defined as the number of days from the day of first LBH589 administration until the patient's death. If a patient was alive at the time of analysis, then the patient's data is censored at the date of the last available evaluation.Survival was assessed every three months until death or final data analysis, whichever occurred first.
Outcome measures
| Measure |
LBH589
n=13 Participants
LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
|
|---|---|
|
Overall Survival
|
18.4 months
Interval 5.8 to
upper limit not reached
|
SECONDARY outcome
Timeframe: Baseline and end of treatment, up to 1 yearChange in serum Thyroglobulin level from baseline to end of treatment. Treatment continued until either extraordinary medical circumstances, disease progression, toxicity, subject withdrawal, or death. At the time subjects came off of study treatment for one of the reasons already listed, a sample was collected for tumor markers.
Outcome measures
| Measure |
LBH589
n=11 Participants
LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
|
|---|---|
|
Impact of LBH589 on Tumor Markers for Thyroid Cancer
|
4.58 ng/mL
Standard Deviation 716.65
|
SECONDARY outcome
Timeframe: Every 4 weeks, up to 5 yearsMost frequent toxicities at least possibly related to panobinostat, grades 2-4 (grading based on NCI common terminology criteria for adverse events CTCAE version 3). Toxicities were collected from the time the patient provided informed consent until 4 weeks after the patient stopped LBH589.
Outcome measures
| Measure |
LBH589
n=13 Participants
LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
|
|---|---|
|
Toxicity of LBH589
Asthenia
|
1 participants
|
|
Toxicity of LBH589
Rash
|
1 participants
|
|
Toxicity of LBH589
Anemia
|
3 participants
|
|
Toxicity of LBH589
Leukopenia
|
7 participants
|
|
Toxicity of LBH589
Neutropenia
|
7 participants
|
|
Toxicity of LBH589
Lymphopenia
|
8 participants
|
|
Toxicity of LBH589
Thrombocytopenia
|
8 participants
|
|
Toxicity of LBH589
Hypoalbuminemia
|
3 participants
|
|
Toxicity of LBH589
Fatigue
|
8 participants
|
|
Toxicity of LBH589
Diarrhea
|
4 participants
|
|
Toxicity of LBH589
Headache
|
1 participants
|
|
Toxicity of LBH589
Bone Pain
|
1 participants
|
|
Toxicity of LBH589
Hyperglycemia
|
1 participants
|
|
Toxicity of LBH589
Hypocalcemia
|
2 participants
|
|
Toxicity of LBH589
Anorexia
|
4 participants
|
|
Toxicity of LBH589
Anxiety
|
1 participants
|
|
Toxicity of LBH589
Elevated GGT
|
1 participants
|
|
Toxicity of LBH589
Pulmonary embolism
|
1 participants
|
SECONDARY outcome
Timeframe: Every 4 weeks, up to 5 yearsTolerability and toxicity were not assessed separately, therefore tolerability is reported as toxicity.
Outcome measures
Outcome data not reported
Adverse Events
LBH589
Serious adverse events
| Measure |
LBH589
n=13 participants at risk
LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
7.7%
1/13
|
|
Blood and lymphatic system disorders
Platelets
|
7.7%
1/13
|
|
General disorders
Death, NOS
|
23.1%
3/13
|
|
General disorders
Hemorrhage/bleeding
|
7.7%
1/13
|
|
Infections and infestations
Colitis, infectious
|
7.7%
1/13
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
7.7%
1/13
|
|
Nervous system disorders
Other
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion, non-malignant
|
7.7%
1/13
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
7.7%
1/13
|
Other adverse events
Adverse event data not reported
Additional Information
Abigail Mapes, Thoracic Oncology Research Program Manager
University of Wisconsin Carbone Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place