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Lung CancerPhase 2NCT00858403

Dasatinib in Advanced Non-small Cell Lung Cancer (NSCL) With Ex Vivo and In Vivo Assessment of Tumor Target Modulation

A Phase 2 study testing Dasatinib in people with Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The main purpose of this study is to learn how patients with Advanced Non-Small Cell Lung Cancer (NSCLC) respond to the study drug Dasatinib. The study drug, Dasatinib, has been approved by the U.S. 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?
Dasatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
Mar 2009to Jul 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Histologically or cytologically documented diagnosis of NSCLC that is advanced/metastatic (Stage IIIB/IV).
  • Performance Status (ECOG) 0-2
  • Previous chemotherapy with the exception of dasatinib. Patients who have had any type of previous chemotherapy regimens for non-small cell lung cancer are eligible.
  • Adequate Organ Function:
  • Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN)
  • Hepatic enzymes (AST, ALT ) ≤ 2.5 times the institutional ULN
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  • Serum Na, K+, Mg2+, Phosphate and Ca2+≥ Lower Limit of Normal (LLN)
  • Serum Creatinine < 1.5 time the institutional ULN
  • Hemoglobin, Neutrophil count, Platelets, prothrombin time (PT), partial thromboplastin time (PTT) all Grade 0-1
  • Ability to take oral medication
  • Concomitant Medications:
  • Agree to discontinue St. Johns Wort while receiving dasatinib therapy
  • Agree that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.
  • Women of childbearing potential (WOCBP):
  • A negative serum or urine pregnancy test within 72 hours prior to the start of study drug administration
  • Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped Prior to study enrollment.
  • Signed written informed consent including a HIPAA form according to institutional Guidelines

Who cannot join

  • No malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 years.
  • Prior dasatinib therapy.
  • Concurrent medical condition which may increase the risk of toxicity, including:
  • Patients with severe pulmonary disease that increases the risk of toxicity related to dasatinib-induced pleural effusions. This includes chronic obstructive pulmonary disease or pleural effusions (malignant or benign) requiring chronic oxygen therapy or patients that have had prior pneumonectomy. Patients that have a pulmonary embolism and require oxygen therapy will be excluded but not those patients who have a pulmonary embolism but do not require oxygen therapy. Patients with active pleural effusions not controlled with pleurodesis will be excluded.
  • Cardiac Symptoms; any of the following should be considered for exclusion:
  • Uncontrolled angina, congestive heart failure or MI within (6 months)
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  • Diagnosed congenital long QT syndrome
  • Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
  • Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
  • Patients with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration
  • History of significant bleeding disorder unrelated to cancer, including:
  • Diagnosed congenital bleeding disorders
  • Diagnosed acquired bleeding disorder within one year
  • Ongoing or recent (≤ 3 months) significant gastrointestinal bleeding
  • Concomitant Medications, any of the following should be considered for exclusion:
  • Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib)
  • quinidine, procainamide, disopyramide
  • amiodarone, sotalol, ibutilide, dofetilide
  • erythromycin, clarithromycin
  • chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
  • cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
  • Women:
  • unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug,or
  • have a positive pregnancy test at baseline
  • pregnant or breastfeeding
  • Prisoners or persons who are compulsorily detained (involuntarily incarcerated)for treatment of either a psychiatric or physical (e.g., infectious) illness
  • Patients on systemic anticoagulation at risk of bleeding related to tumor biopsy that cannot be off anticoagulation per the discretion of their physician.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Phase II Study of Dasatinib in Advanced Non-small Cell Lung Cancer With Ex Vivo and In Vivo Assessment of Tumor Target Modulation

The main purpose of this study is to learn how patients with Advanced Non-Small Cell Lung Cancer (NSCLC) respond to the study drug Dasatinib. The study drug, Dasatinib, has been approved by the U.S. Food and Drug Administration (FDA) for treatment of leukemia, but has not been approved for the treatment of other kinds of cancer. The use of Dasatinib in this study is considered experimental.

Read the detailed description

Cycle 1 Day 1 (C1D1): Patients will have complete history and physical (H\&P), complete blood count (CBC), complete metabolic panel (CMP) and electrocardiogram (EKG) on day 1. Each cycle is 28 days. The C1D1 EKG can be omitted if the patient has no new cardiac symptoms and has not starting taking any medication known to affect QT corrected for heart rate (QTc) prolongation. Any residual toxicity from prior therapy for cancer will be recorded. Blood will be drawn for assessment of serum markers. The patient will begin dasatinib at the starting C1D1 on a daily basis.

Cycle 1 Day 10-20 (C1D10-20): Patients will have a second biopsy to obtain additional tumor material to examine biological effects of dasatinib on signaling pathways. Dasatinib will be taken first thing in the morning and the patient will log the time. Blood will also be drawn for pharmacokinetic assessments of dasatinib levels in plasma and the time recorded. Four FNA aspirates and 2 core biopsies can be obtained either at the bedside for palpable lesions or through appropriate image-guided techniques (CT or US) at the discretion of the treating physician in consultation with radiology. The time of the biopsy will be recorded. One core biopsy should be immediately fixed in formalin and the other core biopsy should be snap frozen in liquid nitrogen.

Cycle 2 Day 1 (C2D1): Patients will be seen by the treating physician and have complete H\&P, CBC, and CMP. Blood will be drawn for assessment of serum markers. Toxicity of dasatinib will be assessed. The patient will continue to take daily doses of dasatinib on a daily basis.

Cycle 2 Day 22 (C2D22): Patients will undergo reevaluation for tumor measurements. This assessment can occur on C2D22 ±7 days.

Conditions
Lung Cancer
Being tested
Dasatinib
Keywords
Advanced Non-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.

  • DasatinibDrug

    Also called SPRYCEL®

    Take tablets of Dasatinib by mouth once a day.

Study groups in NCT00858403
Study groupRoleWhat they receive
Treatment with DasatinibExperimentalDasatinib 140 mg orally (po) every day starting Day #1, continuous dosing. This dose was chosen based on the current experience in patients with solids tumors who have had prior chemotherapy.
Receives: Drug: Dasatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participant Progressors vs. Non-progressors With Tumor Response

    We planned to assess whether the extent of inhibition of extracellular signal-regulated protein kinase (ERK) phosphorylation in lung cancer cells exposed ex vivo to dasatinib significantly differed between patients categorized as progressors or non-progressors through standard Response Evaluation Criteria In Solid Tumors (RECIST)

    Measured: 1 year, 4 months

Secondary outcomes (6)

  1. Number of Participants With Response to Dasatinib

    We planned to estimate the single agent response rate to dasatinib in this patient population

    Measured: 1 year, 4 months

  2. Number of Participants With Progression Free Survival (PFS) at 6 Months

    We planned to estimate the 6 month progression free survival rate of dasatinib in this patient population.

    Measured: 1 year, 4 months

  3. Number of Participants With Serious Adverse Events (SAEs)

    We evaluated toxicity of dasatinib in this patient population.

    Measured: 1 year, 4 months

  4. Number of Participant Progressors vs. Non-Progressors With Inhibition Response

    We planned to assess whether the extent of inhibition of proto-oncogene tyrosine-protein kinase (SRC) and protein kinase B (Akt) phosphorylation in lung cancer cells exposed ex vivo and in vivo to dasatinib significantly differs between patients categorized as progressors or non-progressors through standard RECIST criteria.

    Measured: 1 year, 4 months

  5. Correlation Between Extent of Inhibition and Concentration of Dasatinib

    We planned to explore whether the extent of inhibition of ERK, SRC and Akt phosphorylation in lung cancer cells exposed ex vivo to dasatinib will correlate with the drug concentration of dasatinib.

    Measured: 1 year, 4 months

  6. Correlation Between Mutation and Inhibition and to Disease Control Rate and Response

    To analyze Kras and epidermal growth factor receptor (EGFR) mutation and their correlation to the ERK pathway inhibition and to disease control rate and response.

    Measured: 1 year, 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionJul 2010
  4. Study completionJul 2010

Why it stopped: Slow Accrual

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00858403
Sponsor's protocol ID
MCC-15656
Other IDs
CA180214
Status last verified
Dec 2013
First submitted
5 Mar 2009
Last updated
15 Jan 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dasatinib in people with Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 27 exclusion criteria. 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: stopped early, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participant Progressors vs. Non-progressors With Tumor Response (time frame: 1 year, 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00858403.

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 15 Jan 2014.

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