NCT00470054

Brief Summary

This phase II trial is studying how well dasatinib works in treating patients with relapse small cell lung cancer. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
25 days until next milestone

Results Posted

Study results publicly available

April 26, 2013

Completed
Last Updated

May 5, 2015

Status Verified

June 1, 2014

Enrollment Period

1.8 years

First QC Date

May 3, 2007

Results QC Date

January 2, 2013

Last Update Submit

April 14, 2015

Conditions

Extensive Stage Small Cell Lung CancerLimited Stage Small Cell Lung CancerRecurrent Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 6 Week Progression Free Survival

    Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method. Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions.

    6 weeks

Secondary Outcomes (4)

  • Progression Free Survival (PFS)

    Time from registration to progression (up to 3 years)

  • Response to Therapy

    Assessed every 2 cycles (up to 3 years)

  • Overall Survival

    Time from registration to death (up to 3 years)

  • Number of Participants With Grade 3 or Higher Adverse Events

    Assessed during treatment

Study Arms (1)

Treatment (dasatinib)

EXPERIMENTAL

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

Drug: dasatinib

Interventions

dasatinibDRUG

Given PO

Also known as: BMS-354825, Sprycel
Treatment (dasatinib)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed small cell lung cancer (SCLC) (limited or extensive stage disease)
  • Progressive or recurrent disease after an initial response to first-line treatment with a platinum-based chemotherapy with or without concurrent definitive radiotherapy to the chest (chemotherapy must have been completed at least 90 days prior to documentation of relapse)
  • Measurable disease, defined as \>= 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan
  • Lesions that are not considered measurable include the following:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural or pericardial effusion
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
  • Tumor lesions situated in a previously irradiated area, unless progression after radiotherapy is documented in these lesions
  • No known brain metastases (previously treated brain metastases allowed provided they are neurologically stable for \>= 4 weeks)
  • ECOG performance status 0-1
  • Platelet count \>= 100,000/mm\^3
  • Bilirubin =\< 1.5 times upper limit of normal (ULN)
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Results Point of Contact

Title
Antonius Miller
Organization
Wake Forest University
aamiller@wfubmc.edu

Study Officials

  • Antonius Miller

    Cancer and Leukemia Group B

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 7, 2007

Study Start

April 1, 2007

Primary Completion

February 1, 2009

Study Completion

April 1, 2013

Last Updated

May 5, 2015

Results First Posted

April 26, 2013

Record last verified: 2014-06

Locations

US(1)