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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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.

Study groups in NCT01160731
Study groupRoleWhat they receive
Cisplatin, Etoposide & PanobinostatExperimentalNot 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.

  1. Maximum-tolerated dose (MTD) and recommended dose (RD)

  2. Response rates and toxicity at MTD and RD

  3. Objective response rate according to RECIST criteria

Secondary outcomes (6)
  1. Time to progression according to RECIST criteria

  2. Duration of response or disease stabilization according to RECIST criteria

  3. Overall survival according to RECIST criteria

  4. Effect of the combination regimen on drug pharmacokinetics

  5. Adverse events

  6. 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.

  1. First posted12 Jul 2010 (estimated)
  2. Study startNov 2009
  3. Primary completionOct 2010

Resources

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)
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

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.

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