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OpenTrials
Completed

NCT Number: NCT02297139

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

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.

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Key information

Conditions

Multiple Indications Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dasatinib

Drug

Primary outcomes

  1. Number of Participants Who Received Dasatinib Treatment

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

    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.

  2. Duration of Treatment

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

    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.

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 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 Adverse Events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.

  2. Number of Participants With Serious Adverse Events

    Time frame: 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 (SAEs). SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Nov 21, 2014
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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