Trial Outcomes & Findings for Dasatinib in Polycythemia Vera (NCT NCT00538980)

Last Updated: 2017-06-20

Results Overview

To evaluate the effect of dasatinib on the platelet count and the stabilization of hematocrit when restored by phlebotomy to normal range (HCT \<45% for men, \<42% for women). Analysis was not completed because the study was terminated early due to lack of efficacy.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Lab tests will be performed weekly for the first month, then every 2 weeks for months 2 and 3 and monthly thereafter.

Results posted on

2017-06-20

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day). Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
Overall Study STARTED	10
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dasatinib in Polycythemia Vera

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=10 Participants Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day). Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=39 Participants
Age, Categorical >=65 years	5 Participants n=39 Participants
Sex: Female, Male Female	6 Participants n=39 Participants
Sex: Female, Male Male	4 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants
Race (NIH/OMB) White	10 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Region of Enrollment United States	10 participants n=39 Participants

PRIMARY outcome

Timeframe: Lab tests will be performed weekly for the first month, then every 2 weeks for months 2 and 3 and monthly thereafter.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Patients will evaluated weekly for the first month, then every two weeks forr months 2 and 3, and monthly thereafter.

To determine change in performance status and development of side effects and complications in patients treated under this protocol. Analysis was not completed because the study was terminated early due to lack of efficacy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Bone marrow analysis will be performed at baseline and month 6.

To determine changes in marrow cellularity, reticulin and fibrous content. Analysis was not completed because the study was terminated early due to lack of efficacy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cytogenetics analysis will be performed at baseline and month 6.

To determine change in cytogenetics if initially abnormal. Analysis was not completed because the study was terminated early due to lack of efficacy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: JAK2 analysis will be performed at baseline and month 3.

To determine if quantitative change in JAK2 expression occurs as measured by quantitative pyrosequencing. Analysis was not completed because the study was terminated early due to lack of efficacy.

Outcome measures

Outcome data not reported

Adverse Events

All Patients

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Patients n=10 participants at risk Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day). Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 1/10 • Number of events 1 Adverse events are not included in this report because the data is not available. Every effort was made to retrieve this data from long-term storage, but unfortunately, it could not be obtained.

Other adverse events

Adverse event data not reported

Additional Information

Richard T. Silver, MD

Weill Cornell Medicine

Phone: 646-962-2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place