Lung CancerPhase 1NCT01160731
Panobinostat, Etoposide, and Cisplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
A Phase 1 study testing cisplatin, etoposide phosphate and panobinostat in people with Lung Cancer, run by Cancer Trials Ireland.
Trial summary
RATIONALE: Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as etoposide and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- cisplatin, etoposide phosphate and panobinostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer
- Extensive-stage disease
- Measurable disease according to RECIST criteria
- No symptomatic brain metastasis or meningeal tumors
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 6 months
- Absolute neutrophil count > 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10.0 g/dL
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR 24-hour creatinine clearance ≥ to 60 mL/min
- Magnesium, potassium, and phosphorus ≥ the lower limit of normal OR correctable with supplements prior to study treatment
- AST/ALT ≤ 2.5 x ULN (≤ 5.0 x ULN if hepatic metastases are present)
- Serum bilirubin ≤ 1.5 x ULN
- Alkaline phosphatase ≤ 2.5 x ULN OR liver fraction ≤ 2.5 x ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double contraception (at least 1 barrier method) during and for at least 30 days after completion of study treatment
- No impaired cardiac function, including any one of the following:
- LVEF < 45% as determined by ECHO
- Complete left bundle branch block, obligate use of a cardiac pacemaker, congenital long QT syndrome, history or presence of atrial or ventricular tachyarrhythmias, clinically significant resting bradycardia (< 50 beats per minute), QTcF > 480 msec on screening ECG, or right bundle branch block and left anterior hemiblock (bifascicular block)
- Uncontrolled angina pectoris or acute myocardial infarction within the past 3 months
- Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
- No history of HIV or AIDS-related illness
- No acute or chronic liver or renal disease
- No other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol, including any of the following:
- Uncontrolled diabetes
- Chronic obstructive or chronic restrictive pulmonary disease
- Active or uncontrolled infection
- No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to panobinostat, cisplatin, or etoposide
- No hearing impairment that would be a contraindication to the use of cisplatin
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No investigational drug or experimental medications or treatments within the past 30 days or 5 half-lives, whichever is longer
About this study
Official title: A Phase I Dose Finding Study of the Pan-DAC Inhibitor Panobinostat (LBH589) in Combination With Etoposide and Cisplatin in the First Line Treatment of Extensive-Stage Small Cell Lung Cancer - An ICORG In-House Study
RATIONALE: Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as etoposide and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving panobinostat together with etoposide and cisplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when given together with etoposide and cisplatin as first-line therapy in treating patients with extensive-stage small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose, the recommended dose, and the activity of panobinostat when given in combination with etoposide and cisplatin to patients with extensive-stage small cell lung cancer.
Secondary
- To estimate the time-to-progression, the duration of response, and disease stabilization in these patients.
- To estimate the overall survival of these patients.
- To determine the pharmacokinetic profile of panobinostat in combination with etoposide and cisplatin.
- To assess the overall safety profile of panobinostat in these patients.
- To determine the adverse events in these patients treated with this regimen.
- To assess the quality of life of these patients.
OUTLINE: This is a multicenter, dose-escalation study of panobinostat.
Patients receive chemotherapy comprising cisplatin IV on day 1, etoposide IV on days 1-3, and panobinostat IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then periodically during study treatment and follow up, using questionnaire EQ-5D (Euro QoL).
Blood samples may be collected at baseline and periodically during and after study treatment for pharmacokinetic assessment and biomarker translational studies.
After completion of study treatment, patients are followed up at 4 weeks and then every 3 months.
- Conditions
- Lung Cancer
- Being tested
- cisplatin, etoposide phosphate, panobinostat, laboratory biomarker analysis, pharmacological study
- Keywords
- extensive stage small cell lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
etoposide phosphateDrug
panobinostatDrug
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin, Etoposide & Panobinostat | Experimental | Not described Receives: Drug: cisplatin; Drug: etoposide phosphate; Drug: panobinostat; Other: laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum-tolerated dose (MTD) and recommended dose (RD)
Response rates and toxicity at MTD and RD
Objective response rate according to RECIST criteria
Secondary outcomes (6)
Time to progression according to RECIST criteria
Duration of response or disease stabilization according to RECIST criteria
Overall survival according to RECIST criteria
Effect of the combination regimen on drug pharmacokinetics
Adverse events
Quality of life evaluated by EQ-5D (Euro QoL)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startNov 2009
- Primary completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Paul Donnellan, Principal investigator, Galway University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160731
- Sponsor's protocol ID
- 07-09 ICORG
- Other IDs
- ICORG-07-09, EUDRACT-2008-003634-21, EU-21047
- Status last verified
- Oct 2012
- First submitted
- 9 Jul 2010
- Last updated
- 31 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Finding Study of the Pan-DAC Inhibitor Panobinostat (LBH589) in Combination With Etoposide and Cisplatin in the First Line Treatment of Extensive-Stage Small Cell Lung Cancer - An ICORG In-House Study
- ClinicalTrials.gov ID
- NCT01160731
- Acronym / sponsor ID
- 07-09 ICORG
- Conditions
- Lung Cancer
- Keywords
- extensive stage small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Nov 2009
- Primary completion
- Oct 2010 (actual)
- First posted
- 12 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as etoposide and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving panobinostat together with etoposide and cisplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when given together with etoposide and cisplatin as first-line therapy in treating patients with extensive-stage small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose, the recommended dose, and the activity of panobinostat when given in combination with etoposide and cisplatin to patients with extensive-stage small cell lung cancer.
Secondary
- To estimate the time-to-progression, the duration of response, and disease stabilization in these patients.
- To estimate the overall survival of these patients.
- To determine the pharmacokinetic profile of panobinostat in combination with etoposide and cisplatin.
- To assess the overall safety profile of panobinostat in these patients.
- To determine the adverse events in these patients treated with this regimen.
- To assess the quality of life of these patients.
OUTLINE: This is a multicenter, dose-escalation study of panobinostat.
Patients receive chemotherapy comprising cisplatin IV on day 1, etoposide IV on days 1-3, and panobinostat IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then periodically during study treatment and follow up, using questionnaire EQ-5D (Euro QoL).
Blood samples may be collected at baseline and periodically during and after study treatment for pharmacokinetic assessment and biomarker translational studies.
After completion of study treatment, patients are followed up at 4 weeks and then every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin, Etoposide & Panobinostat | Experimental | Drug: cisplatin, Drug: etoposide phosphate, Drug: panobinostat, Other: laboratory biomarker analysis, Other: pharmacological study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin | Drug | Cisplatin, Etoposide & Panobinostat |
| etoposide phosphate | Drug | Cisplatin, Etoposide & Panobinostat |
| panobinostat | Drug | Cisplatin, Etoposide & Panobinostat |
| laboratory biomarker analysis | Other | Cisplatin, Etoposide & Panobinostat |
| pharmacological study | Other | Cisplatin, Etoposide & Panobinostat |
Primary outcome
Maximum-tolerated dose (MTD) and recommended dose (RD)
Response rates and toxicity at MTD and RD
Objective response rate according to RECIST criteria
6 secondary outcomes
Time to progression according to RECIST criteria
Duration of response or disease stabilization according to RECIST criteria
Overall survival according to RECIST criteria
Effect of the combination regimen on drug pharmacokinetics
Adverse events
Quality of life evaluated by EQ-5D (Euro QoL)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Donnellan principal investigator
Galway University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cisplatin, etoposide phosphate and panobinostat in people with Lung Cancer, run by Cancer Trials Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum-tolerated dose (MTD) and recommended dose (RD). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.