Ignite Creation Date:
2024-05-05 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00624585
Status:
COMPLETED
Last Update Posted:
2013-12-16
First Post:
2008-02-15
Brief Title:
Study of Oral Dasatinib in Subjects With Myelodysplastic Syndrome MDS and Excess Marrow Blasts
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Pilot Study of Oral Dasatinib in Subjects With MDS and Excess Marrow Blasts
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to learn how patients with myelodysplastic syndrome MDS respond to the study drug dasatinib The study drug dasatinib has been approved by the US Food and Drug Administration FDA for treatment of leukemia but has not been approved for the treatment of other kinds of cancer The use of dasatinib in this study is considered experimental
Detailed Description:
Study Core Period
The first 16 weeks after the initial dose of dasatinib is called the Study Core Period Patients who are eligible and chose to participate in this study should expect to take 100 mg of dasatinib daily for 8 weeks If the study doctor believes that they have not achieved a partial response after 8 weeks of treatment the dose may be increased to 150 mg per day The study doctor may lower the dosage of dasatinib if the 100 mg treatment is too strong If the lower dose of dasatinib is still too strong the study doctor may decide to take the patient off of the study The patient will continue to receive supportive care as needed during the duration of the trial as well as after completion of the trial
During the Study Core Period participants will have a study visit every 4 weeks Complete Blood Counts CBCs will be obtained every 2 weeks for study purposes and disease monitoring Bone marrow aspiration and biopsy will be obtained at screening and at 8 weeks and 16 weeks of treatment for response assessment Additional bone marrow aspirations and biopsies may be obtained at any other time to evaluate the disease process at the doctors judgment A bone marrow aspirate and biopsy must be done at the time of study discontinuation
Study Extension Period
The time after the first 16 weeks of treatment is called the study extension period If the patient is responding to the treatment does not experience disease progression or any severe adverse events the patient may continue dasatinib treatment for up to 48 weeks If patients continue after 48 weeks they will be asked to enroll in a separate extension study for future follow up
During the Study Extension Period participants will have a study visit every 4 weeks Complete Blood Counts CBCs will be obtained every 2 or 4 weeks for study purposes and disease monitoring Bone marrow aspiration and biopsy will be obtained every 16 weeks A bone marrow aspirate and biopsy must be done at the time of study discontinuation
The first 16 weeks after the initial dose of dasatinib is called the Study Core Period Patients who are eligible and chose to participate in this study should expect to take 100 mg of dasatinib daily for 8 weeks If the study doctor believes that they have not achieved a partial response after 8 weeks of treatment the dose may be increased to 150 mg per day The study doctor may lower the dosage of dasatinib if the 100 mg treatment is too strong If the lower dose of dasatinib is still too strong the study doctor may decide to take the patient off of the study The patient will continue to receive supportive care as needed during the duration of the trial as well as after completion of the trial
During the Study Core Period participants will have a study visit every 4 weeks Complete Blood Counts CBCs will be obtained every 2 weeks for study purposes and disease monitoring Bone marrow aspiration and biopsy will be obtained at screening and at 8 weeks and 16 weeks of treatment for response assessment Additional bone marrow aspirations and biopsies may be obtained at any other time to evaluate the disease process at the doctors judgment A bone marrow aspirate and biopsy must be done at the time of study discontinuation
Study Extension Period
The time after the first 16 weeks of treatment is called the study extension period If the patient is responding to the treatment does not experience disease progression or any severe adverse events the patient may continue dasatinib treatment for up to 48 weeks If patients continue after 48 weeks they will be asked to enroll in a separate extension study for future follow up
During the Study Extension Period participants will have a study visit every 4 weeks Complete Blood Counts CBCs will be obtained every 2 or 4 weeks for study purposes and disease monitoring Bone marrow aspiration and biopsy will be obtained every 16 weeks A bone marrow aspirate and biopsy must be done at the time of study discontinuation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA180-106 | OTHER | Bristol-Myers Squibb | None |