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Non-small Cell Lung CancerPhase 2NCT00459342

Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

A Phase 2 study testing dasatinib in people with Non-small Cell Lung Cancer and Recurrent Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
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
35 participants
Where
1 siteUnited States
Study dates
Mar 2007to Apr 2012
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

  • Platelet count >= 100,000/mm^3
  • Histologically or cytologically confirmed non-small cell lung cancer meeting 1 of the following criteria:
  • Stage IV disease
  • Stage IIIB disease with pleural effusion
  • Recurrent disease after surgery or radiotherapy
  • Measurable disease, defined as >= 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
Show all 46Show fewer
  • Previously treated brain metastasis allowed, provided there is no bleeding, no midline shift, no need for steroids or anti-convulsants, and no symptoms
  • Must agree to obtain residual tumor tissue available from the existing diagnostic biopsy tumor tissue
  • Eastern cooperative oncology group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 60-100%
  • Life expectancy > 12 weeks
  • White blood cell (WBC) >= 3,000/mm^3
  • Absolute neutrophil count >= 1,500/mm^3
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and ALT =< 2.5 times ULN
  • Creatinine =< 3 times ULN OR Creatinine clearance >= 60 mL/min
  • No uncontrolled congestive heart failure or potentially life-threatening arrhythmia
  • No angina at rest
  • No neuropathy >= grade 2
  • No chronic diarrhea or history of inflammatory bowel disease
  • No history of pulmonary fibrosis (other than in an irradiated field)
  • No other concurrent serious medical illness
  • O2 saturation > 92% on room air
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions to compounds of similar chemical or biological composition to dasatinib
  • No heart rate-corrected QT interval (QTc) prolongation (i.e., QTC >= 480 msec) or other significant ECG abnormalities that could lead to adverse effects if the QTc interval were prolonged
  • No medical condition that impairs the ability to swallow, retain, or absorb dasatinib including, but not limited to, any of the following:
  • Gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, prior surgical procedures affecting absorption, active peptic ulcer disease
  • No myocardial infarction or ventricular tachyarrhythmia within the past 6 months
  • left ventricular ejection fraction (LVEF) normal
  • No major conduction abnormality (unless cardiac pacemaker is present)
  • No ongoing or active infection
  • No history of significant bleeding disorder (congenital [von Willebrand's disease] or acquired [antifactor VIII antibodies])
  • No psychiatric illness or social situation that would preclude study compliance
  • No prior chemotherapy or biologic therapy for recurrent or metastatic non-small cell lung cancer
  • Adjuvant cytotoxic chemotherapy after surgical resection or chemotherapy with radiation for locally advanced disease (curative intent) allowed provided disease recurrence >= 3 months after completion of last chemotherapy dose
  • Measurable disease must be outside the radiotherapy port OR clearly growing inside the port
  • No prior radiotherapy to >= 25% of the marrow-containing skeleton
  • At least 7 days since prior and no concurrent medications that are inhibitors or inducers of CYP3A4
  • At least 7 days since prior and no concurrent agents with proarrhythmic potential
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No concurrent systemic antacids (H2 receptor antagonists and proton pump inhibitors)
  • Locally acting antacids allowed except for 2 hours before and after dasatinib administration

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Study of Dasatinib in Non Small Cell Lung Cancer

Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the progression-free survival at 12 weeks in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with dasatinib.

SECONDARY OBJECTIVES:

  1. Determine the rate of response in patients treated with this drug. II. Examine the relationship between clinical response to this drug and epidermal growth factor receptor (EGFR) mutational status, EGFR copy number, and (phosphorylated Src) pSrc expression levels in pre-treatment tumor biopsies.

III. Determine the toxicity of this drug.

OUTLINE:

Patients received oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Previously obtained paraffin-embedded tumor tissue samples are analyzed by polymerase chain reaction and fluorescent in situ hybridization (FISH) for epidermal growth factor receptor and by immunohistochemistry for pSrc expression.

Being tested
dasatinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dasatinibDrug

    Also called BMS-354825, Sprycel

    Given orally

Study groups in NCT00459342
Study groupRoleWhat they receive
Arm IExperimentalPatients received oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: dasatinib

What is being measured

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

  1. Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR))

    Objective response defined as participants with Complete Response (CR) or Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RECIST definitions are Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Response measured by tumor size on computed tomography scans and by metabolic activity on positron emission tomography scans.

    Measured: 12 weeks

  2. Progression-free Survival (PFS)

    Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death.

    Measured: Time from start of treatment to time of progression or death, assessed at 2 months

Timeline

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

  1. First posted11 Apr 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionApr 2012
  4. Study completionApr 2012

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
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00459342
Sponsor's protocol ID
NCI-2009-00225
Other IDs
NCI-2009-00225, CDR0000538668, 2006-0593, 2006-0593, 7798, N01CM62202, P30CA016672
Status last verified
Feb 2019
First submitted
9 Apr 2007
Last updated
5 Mar 2019

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dasatinib in people with Non-small Cell Lung Cancer and Recurrent Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) 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 46 inclusion and 0 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: finished, as of the sponsor's last update on 5 Mar 2019. 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 24 Dec 2013). 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 Participants With Objective Response (Complete Response (CR) or Partial Response (PR)) (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT00459342.

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 5 Mar 2019.

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