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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02297139
• Collaborator: (none)
• Enrollment: 17
• Locations: 6
• Arm: 1
• Anticipated Duration (Months): 80
• Patients Per Site: 2.8
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Indications Cancer	Drug: Dasatinib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib
• Actual Study Start Date: Jul 31, 2015
• Anticipated Primary Completion Date: Mar 29, 2022
• Anticipated Study Completion Date: Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Dasatinib

Outcome Measures

Primary Outcome Measures

1. Number of subjects who received dasatinib treatment and duration of treatment will be collected [Duration of Study (Approximately up to 2 years)]

Secondary Outcome Measures

1. All serious adverse event (SAE)s and adverse event (AE)s will be collected [Duration of Study (Approximately up to 2 years)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Besancon		France	25000
2	Local Institution	Chorzow		Poland	41-500
3	Local Institution	Krakow		Poland	30-510
4	Local Institution	Lodz		Poland	93-510
5	Local Institution	Warsaw		Poland	02776
6	Local Institution	Wroclaw		Poland	50-367

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02297139
• Other Study ID Numbers: CA180-597
• First Posted: Nov 21, 2014
• Last Update Posted: Dec 17, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Dasatinib

Study Results

No Results Posted as of Dec 17, 2021