NCT00436605

Brief Summary

This phase II trial is studying how well dasatinib works in treating patients with stage III melanoma that cannot be removed by surgery or stage IV melanoma. 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
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2006

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

January 20, 2014

Completed
Last Updated

May 15, 2014

Status Verified

October 1, 2011

Enrollment Period

3.2 years

First QC Date

February 15, 2007

Results QC Date

December 5, 2013

Last Update Submit

April 29, 2014

Conditions

Recurrent MelanomaStage IIIA MelanomaStage IIIB MelanomaStage IIIC MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects With Objective Response(Partial Response and Complete Response) as Measured by RECIST Criteria

    Only those patients who have measurable disease present at baseline, have received at least one course of therapy, and have had their disease re-evaluated will be considered evaluable for response. A Simon's optimum two-stage design will be used.

    After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment

  • Progression-free Survival

    Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon's optimum two-stage design will be used

    Time from start treatment to time of progression, assessed up to 6 months

Study Arms (1)

Treatment (kinase inhibitor therapy)

EXPERIMENTAL

Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: dasatinib

Interventions

dasatinibDRUG
Also known as: BMS-354825, Sprycel
Treatment (kinase inhibitor therapy)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed stage III unresectable or stage IV melanoma
  • Measurable disease
  • Must have evidence of tumor growth or new lesions within the past 6 months
  • No large pleural effusions
  • No known brain metastases or leptomeningeal metastases
  • Previously treated brain metastases allowed provided there is no requirement for steroids AND no evidence of progression for ≥ 8 weeks after treatment
  • ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
  • Life expectancy \> 3 months
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
  • Bilirubin ≤ 1.5 mg/mL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • PT/INR and PTT normal
  • +44 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale University

New Haven, Connecticut, 06520, United States

Location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Results Point of Contact

Title
Harriet Kluger
Organization
Yale University School of Medicine
Harriet.Kluger@yale.edu
203-737-2572

Study Officials

  • Harriet Kluger

    Yale University

    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

February 15, 2007

First Posted

February 19, 2007

Study Start

December 1, 2006

Primary Completion

March 1, 2010

Study Completion

November 1, 2010

Last Updated

May 15, 2014

Results First Posted

January 20, 2014

Record last verified: 2011-10

Locations

US(2)