A Phase 1 interventional study of Panobinostat, Cisplatin, Pemetrexed in Solid Tumors and Non-Small Cell Lung Cancer (NSCLC), sponsored by University of California, Davis. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-09.
Sponsored by University of California, Davis · Phase 1, Interventional, and Treatment
The purpose of this study is to find out if panobinostat taken with cisplatin and pemetrexed can be used safely without increasing side effects and that the combination will have a better effect than platinum-based doublet chemotherapy alone.
The purpose of this phase I study of oral panobinostat plus cisplatin and pemetrexed is to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) in patients with advanced solid tumors, with an emphasis in non-small cell lung cancer. Another purpose of this study is to find out if oral panobinostat in combination with cisplatin and pemetrexed can be administered safely without significant increase in toxicity and that the combination will increase efficacy compared to platinum-based doublet chemotherapy alone.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 23 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Hematology:
Biochemistry:
Exclusion Criteria:
Drug: panobinostat Drug: cisplatin Drug: pemetrexed Other: Biomarker studies
Drug: Panobinostat, Cisplatin, Pemetrexed
Drug: Panobinostat Oral (by mouth) once daily every Monday, Wednesday, and Friday for the first two weeks of each three week cycle (as per dose escalation schedule (dose levels 1 and 2: AUC 5; dose levels 3 and 4: AUC 6). Number of cycles: 6 maximum. Drug: Cisplatin IV (in the vein) on day 1 of a 21-day cycle Number of cycles: 6 maximum. Drug: Pemetrexed IV (in the vein) on day 1 of a 21-day cycle Other: Correlative studies Biomarker Analysis: blood collected pre-study and Cycles 2-6, Day 1.
Also known as: LBH-589, Platinol, Almita
Safety and feasibility of oral panobinostat in combination with cisplatin and pemetrexed
Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs and the performance of physical examination. Safety and tolerability will be assessed according to the NCI CTCAE v4.
Time frame: Within ±3 days of the scheduled day of assessment except for adverse events that will be evaluated continuously through the study. The expected time frame for this outcome measure is 18 weeks (or six cycles)
Maximum-tolerated dose as assessed by NCI CTCAE, Version 4.0
Determination of maximum tolerated dose (MTD) will be based on cycle 1 toxicities
Time frame: 3 week cycle; the expected time frame is 18 weeks (or 6 cycles)
Dose-limiting toxicities and toxicity profile as assessed by NCI CTCAE, Version 4.0
Dose-limiting toxicity (DLT) will be based on cycle 1 toxicities.
Time frame: 3 week cycle; the expected time frame is 18 weeks (or 6 cycles)
Exploratory biomarker analysis
Molecular markers predictive for response to panobinostat remain unknown. This trial offers the opportunity to retrospectively study biomarkers and their association with clinical outcomes.
Time frame: Blood specimens will be collected prior to treatment, prior to Cycles 2-6. In addition, a blood specimen will be collected if the patient is removed from the study due to progression of disease. the expected time frame is 18 weeks (or 6 cycles)
Efficacy of oral panobinostat in combination with cisplatin/pemetrexed in an expanded cohort of patients with NSCLC
Response rate will be assessed by CT scan. CT scans will be performed at baseline and every two cycles. The evaluation of response will be based on standard RECIST criteria.
Time frame: CT scans will be performed at baseline and every two cycles; the expected time frame is 18 weeks (or 6 cycles)
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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University of California, Davis