Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib

NCT ID: NCT02297139

Last Updated: 2023-05-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2022-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Indications Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Dasatinib

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

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

Interventions

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Dasatinib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Besançon, , France

Site Status

Local Institution - 0006

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Local Institution

Chorzów, , Poland

Site Status

Local Institution

Lodz, , Poland

Site Status

Local Institution - 0003

Warsaw, , Poland

Site Status

Local Institution - 0002

Wroclaw, , Poland

Site Status

Countries

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France Poland

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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CA180-597

Identifier Type: -

Identifier Source: org_study_id

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