Dasatinib in Advanced Squamous Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01491633
Recruitment Status : Terminated (Safety issues/concerns per DF/HCC PI)
First Posted : December 14, 2011
Results First Posted : July 15, 2014
Last Update Posted : July 15, 2014
Information provided by (Responsible Party):
Bruce Johnson, MD, Dana-Farber Cancer Institute

Brief Summary:

Dasatinib is a drug that has been shown to stop some cancer cells from growing. This drug has been used in treatment for other types of cancer and information from other research studies suggests that dasatinib may help to stop squamous cell lung cancer from growing, especially in individuals whose tumor has a mutation in the DDR2 gene.

Advanced squamous cell lung cancer (SqCC) carries a poor prognosis and new therapeutic targets are needed. Several studies have examined dasatinib in NSCLC; these report significant toxicities, but also responses in patients found to harbor mutations in DDR2 or BRAF.

An open-label phase II trial with dasatinib was carried out to determine the response rates in patients with SqCC who had previously failed standard chemotherapy and to correlate responses with patient genotype.

Condition or disease Intervention/treatment Phase
Squamous Cell Lung Cancer Drug: Dasatinib Phase 2

Detailed Description:

Dasatinib will be taken orally, daily in cycles of 28 days.

On the first day of study treatment and at 2 weeks, 4 weeks and then every 4 weeks subjects will have the following:

  • Medical history and clinical exam
  • Safety blood tests
  • Measurement of Performance Status
  • Review of pill log
  • CT scans will be done every 8 weeks.

In this research study, the investigators are looking at how well dasatinib works in treating squamous cell lung cancer.

Dasatinib administered at 140mg per day for the treatment of advanced SqCC of the lung is associated with excess adverse events, similar to other studies, so is not recommended in unselected patients. Further work to identify patients likely to benefit from dasatinib and in managing dasatinib-related toxicities is needed.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Dasatinib in Advanced (Stage IIIB/IV) Squamous Cell Lung Cancer
Study Start Date : September 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Dasatinib

Arm Intervention/treatment
Experimental: Dasatinib
Dasatinib 140 mg by mouth each day
Drug: Dasatinib
140 mg orally, daily in 28 day cycles
Other Name: BMS-354825

Primary Outcome Measures :
  1. Response Rate [ Time Frame: 2 years ]
    Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib

Secondary Outcome Measures :
  1. Types and Frequency of DDR2 Mutations [ Time Frame: 2 years ]
    Determine frequency of DDR2 mutations in study patients

  2. Survival [ Time Frame: 2 years ]
    Establish the overall survival of patients with SCC treated with dasatinib

  3. Toxicities [ Time Frame: 2 years ]
    Define the toxicities of dasatinib when administered to the patient population. NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 will be utilized for adverse event reporting.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stage III/B or IV squamous NSCLC
  • Measurable disease
  • Previously offered all standard chemotherapy regimens for advanced squamous cell lung cancer
  • ECOG performance status of 0 or 1
  • Estimated life expectancy greater than 12 weeks
  • Normal organ and marrow function
  • Confirmed availability of archival pathology samples
  • Agrees to discontinue St. Johns Wort
  • Able to take medications by mouth
  • Willing and able to use acceptable method of birth control for the entire study period and for at least 4 weeks after the last dose of study drug

Exclusion Criteria:

  • Pregnant or breast-feeding
  • Chemotherapy or radiotherapy within 4 weeks prior to entering study
  • Receiving any other investigational agents
  • Known untreated or progressive brain metastases
  • History of prior treatment with or allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib, nilotinib or imatinib
  • Taking medications known to be potent CYP3A4 inhibitors
  • Currently taking H2 inhibitors or proton pump inhibitors
  • Currently taking drugs or have taken drugs in the past 7 days that are generally accepted to have a risk of causing Torsades de Pointes
  • HIV positive
  • Clinically uncontrolled hypertension (blood pressure > 160/110)
  • Previous or concurrent malignancy except adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 5 years
  • Active and uncontrolled clinically significant infection
  • Chronic gastrointestinal disease
  • Acquired or congenital bleeding disorder or clinically significant gastrointestinal bleeding within 3 months
  • Supplemental oxygen required for current malignancy
  • Evidence of symptomatic pleural effusions unless undergoing a therapeutic thoracentesis as part of non-study care
  • Individuals who are prisoners or who are compulsory detained for medical or psychiatric reasons
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01491633

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Principal Investigator: Bruce Johnson, MD Dana-Farber Cancer Institute

Publications of Results:
Responsible Party: Bruce Johnson, MD, Professor of Medicine, Harvard Medical School, Dana-Farber Cancer Institute Identifier: NCT01491633     History of Changes
Other Study ID Numbers: 11-142
First Posted: December 14, 2011    Key Record Dates
Results First Posted: July 15, 2014
Last Update Posted: July 15, 2014
Last Verified: June 2014

Keywords provided by Bruce Johnson, MD, Dana-Farber Cancer Institute:
Lung cancer
Stage IIIB
Stage IV

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action