Dasatinib in Advanced Squamous Cell Lung Cancer

NCT01491633 | Terminated Phase 2 Results DMC

• 1 other identifier: 11-142
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

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.

Conditions

Squamous Cell Lung Cancer

Keywords

Lung cancer; NSCLC; Stage IIIB; Stage IV

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib

  2 years

Secondary Outcomes (3)

• Types and Frequency of DDR2 Mutations

  2 years

• Survival

  2 years

• Toxicities

  2 years

Study Arms (1)

Dasatinib

EXPERIMENTAL

Dasatinib 140 mg by mouth each day

Drug: Dasatinib

Interventions

Dasatinib DRUG

140 mg orally, daily in 28 day cycles

Also known as: BMS-354825

Dasatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Brunner AM, Costa DB, Heist RS, Garcia E, Lindeman NI, Sholl LM, Oxnard GR, Johnson BE, Hammerman PS. Treatment-related toxicities in a phase II trial of dasatinib in patients with squamous cell carcinoma of the lung. J Thorac Oncol. 2013 Nov;8(11):1434-7. doi: 10.1097/JTO.0b013e3182a47162.

  PMID: 24128713 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

Due to the toxicity of the study agent no subjects were evaluable for response

Results Point of Contact

• Title: Dr. Peter Hammerman
• Organization: Dana-Farber Cancer Institute

phammerman@partners.org

617-632-3000

Study Officials

• Bruce Johnson, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: December 14, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 15, 2014
• Results First Posted: July 15, 2014

Record last verified: 2014-06

Locations

US (3)