Trial Outcomes & Findings for Dasatinib in Treating Patients With Stage III Melanoma That Cannot Be Removed By Surgery or Stage IV Melanoma (NCT NCT00436605)

NCT ID: NCT00436605

Last Updated: 2014-05-15

Results Overview

Only those patients who have measurable disease present at baseline, have received at least one course of therapy, and have had their disease re-evaluated will be considered evaluable for response. A Simon's optimum two-stage design will be used.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 39 participants
• Primary outcome timeframe: After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment
• Results posted on: 2014-05-15

Participant Flow

Participant milestones

Measure	Treatment (Kinase Inhibitor Therapy) Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	39
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Treatment (Kinase Inhibitor Therapy) Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study Protocol Violation	3

Baseline Characteristics

Dasatinib in Treating Patients With Stage III Melanoma That Cannot Be Removed By Surgery or Stage IV Melanoma

Baseline characteristics by cohort

Measure	Treatment (Kinase Inhibitor Therapy) n=39 Participants Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment

Only those patients who have measurable disease present at baseline, have received at least one course of therapy, and have had their disease re-evaluated will be considered evaluable for response. A Simon's optimum two-stage design will be used.

Outcome measures

Measure	Treatment (Kinase Inhibitor Therapy) n=36 Participants Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Number of Subjects With Objective Response(Partial Response and Complete Response) as Measured by RECIST Criteria	2 participants

PRIMARY outcome

Timeframe: Time from start treatment to time of progression, assessed up to 6 months

Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon's optimum two-stage design will be used

Outcome measures

Measure	Treatment (Kinase Inhibitor Therapy) n=36 Participants Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Progression-free Survival	8 weeks Interval 3.0 to 136.0

Adverse Events

Treatment (Kinase Inhibitor Therapy)

Serious events: 20 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Kinase Inhibitor Therapy) n=39 participants at risk Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
General disorders Fatigue	12.8% 5/39
Respiratory, thoracic and mediastinal disorders Dyspnea	10.3% 4/39
Respiratory, thoracic and mediastinal disorders Pleural Effusion	7.7% 3/39
Gastrointestinal disorders Nausea	7.7% 3/39
Gastrointestinal disorders Diarrhea	5.1% 2/39
General disorders Anorexia	7.7% 3/39

Other adverse events

Measure	Treatment (Kinase Inhibitor Therapy) n=39 participants at risk Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
General disorders Fatigue	76.9% 30/39
Respiratory, thoracic and mediastinal disorders Dyspnea	69.2% 27/39
Respiratory, thoracic and mediastinal disorders Pleural Effusion	35.9% 14/39
Gastrointestinal disorders Nausea	66.7% 26/39
Gastrointestinal disorders Emesis	23.1% 9/39
Gastrointestinal disorders Diarrhea	35.9% 14/39
General disorders Weight Loss	20.5% 8/39
Skin and subcutaneous tissue disorders Rash	43.6% 17/39
Skin and subcutaneous tissue disorders Pruritis	17.9% 7/39
General disorders Anorexia	59.0% 23/39
General disorders Xerostomia	33.3% 13/39
Gastrointestinal disorders Heartburn	15.4% 6/39
Gastrointestinal disorders Taste Alternation	20.5% 8/39
Vascular disorders Edema	12.8% 5/39
Respiratory, thoracic and mediastinal disorders Cough	33.3% 13/39

Additional Information

Harriet Kluger

Yale University School of Medicine

Phone: 203-737-2572

Email: Harriet.Kluger@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60