NCT02297139

Brief Summary

The purpose of this study is to continue to provide dasatinib to patients that are currently participating in another dasatinib trial that is ending and for which there is no other option to provide dasatinib.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_2

Geographic Reach
2 countries

6 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

First Submitted

Initial submission to the registry

November 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

July 31, 2015

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
12 months until next milestone

Results Posted

Study results publicly available

May 6, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

6.8 years

First QC Date

November 19, 2014

Results QC Date

April 13, 2023

Last Update Submit

April 13, 2023

Conditions

Multiple Indications Cancer

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Who Received Dasatinib Treatment

    Number of participants who received dasatinib treatment for prostate cancer and chronic phase chronic myeloid leukemia who had also participated on prior protocols CA180-227, CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.

    From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)

  • Duration of Treatment

    Duration of treatment for participants who received dasatinib treatment for prostate cancer and chronic phase chronic myeloid leukemia who had also participated on prior protocols CA180-227, CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.

    From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)

Secondary Outcomes (2)

  • Number of Participants With Adverse Events

    From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)

  • Number of Participants With Serious Adverse Events

    From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months)

Study Arms (1)

Dasatinib

EXPERIMENTAL

This is a continuation roll-over study for patients receiving benefit from prior dasatinib protocols. All subjects will receive dasatinib as per previous protocol

Drug: Dasatinib

Interventions

DasatinibDRUG
Dasatinib

Eligibility Criteria

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

You may qualify if:

  • Participated in and completed a previous dasatinib protocol (including but not limited to CA180056, CA180363 or CA180227) and is deemed by the investigator to be deriving benefit from dasatinib as defined by the previous protocol
  • Receiving dasatinib at the time of signature of informed consent
  • Males and Females, ages 18 and older

You may not qualify if:

  • All patients previously discontinued from a dasatinib study for any reason
  • Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
  • History of allergy to dasatinib

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Local Institution

Besançon, 25000, France

Location

Local Institution - 0006

Krakow, Lesser Poland Voivodeship, 30-727, Poland

Location

Local Institution

Chorzów, 41-500, Poland

Location

Local Institution

Lodz, 93-510, Poland

Location

Local Institution - 0003

Warsaw, 02776, Poland

Location

Local Institution - 0002

Wroclaw, 50-367, Poland

Location

Related Links

MeSH Terms

Interventions

Dasatinib

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com
Please email

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2014

First Posted

November 21, 2014

Study Start

July 31, 2015

Primary Completion

May 15, 2022

Study Completion

May 15, 2022

Last Updated

May 6, 2023

Results First Posted

May 6, 2023

Record last verified: 2023-04

Locations

FR(1)PL(5)