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CompletedPhase 2NCT00570401
Official study title

Dasatinib in Treating Patients With Advanced Lung Cancer That Is No Longer Responding to Erlotinib or Gefitinib

Study summary

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with advanced lung cancer that is no longer responding to erlotinib or gefitinib.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studieddasatinib

The study team can explain what participation involves.

Who it may be forLung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 22, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Memorial Sloan Kettering Cancer Center
Interventions being studied
Drug: dasatinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • DISEASE CHARACTERISTICS:
  • Pathologically confirmed adenocarcinoma of the lung
  • Advanced disease
  • Previously treated with erlotinib hydrochloride or gefitinib for 6 months (at any time) and meets 1 of the following criteria:
  • Previously received treatment with erlotinib hydrochloride or gefitinib\
  • and had a radiographic partial or complete response to treatment with erlotinib hydrochloride or gefitinib as defined by RECIST or WHO criteria
  • Documented mutation in EGFR from tumor DNA NOTE: \*Patients may have received other treatments subsequently including radiation or chemotherapy
  • Must have developed acquired resistance to erlotinib hydrochloride or gefitinib
  • Radiographic evidence of disease progression during treatment with erlotinib hydrochloride or gefitinib
  • Have previously undergone a biopsy of a site of progressive disease on protocol MSKCC 04-103\
  • NOTE: \*Results of this biopsy are not required to be enrolled on this trial
  • Measurable indicator lesions have not been previously irradiated
  • No CNS lesion that is symptomatic and/or requiring escalating doses of corticosteroids PATIENT CHARACTERISTICS:
  • Karnofsky performance status 70-100%
  • WBC ≥ 3,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatinine ≤ 2 mg/dL or creatinine clearance ≥ 55 mL/min
  • QTc \< 450 msec
  • Able to take oral medications
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 4 weeks after study drug is stopped
  • No significant medical history or unstable medical condition, including any of the following:
  • History of diagnosed congenital long QT syndrome
  • Ventricular arrhythmia
  • Congestive heart failure
  • Recent myocardial infarction
  • Unstable angina
  • Active infection
  • Uncontrolled hypertension PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • At least 3 weeks since prior cytotoxic chemotherapy
  • At least 3 weeks since prior radiation therapy to a major bone-marrow containing area
  • At least 7 days since prior 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, or lidoflazine

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Memorial Sloan-Kettering Cancer CenterNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 22, 2016. Always confirm current availability with the study team.

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