Trial Outcomes & Findings for Dasatinib in Treating Patients With Locally Advanced or Metastatic Mucosal Melanoma, Acral Melanoma, or Vulvovaginal Melanoma That Cannot Be Removed By Surgery (NCT NCT00700882)

Last Updated: 2023-07-03

Results Overview

Objective response is defined as complete response (CR) or partial response (PR) per Solid Tumor Response Criteria (RECIST). Complete response is defined as disappearance of all target and non-target lesions. Partial response is defined as at least 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

81 participants

Primary outcome timeframe

Every 6 weeks; up to 5 years

Results posted on

2023-07-03

Participant Flow

A total of 81 patients were accrued between May 1, 2009 and December 28, 2015 and the study was closed due to slow accrual. The first patient was accrued on July 2, 2009.

Participant milestones

Participant milestones
Measure	Dasatinib Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	81
Overall Study Received Protocol Therapy	75
Overall Study Eligible and Treated Patients	73
Overall Study Eligible, Treated and KIT+ Patients	22
Overall Study Eligible and Treated Patients With Objective Response	7
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	59

Reasons for withdrawal

Reasons for withdrawal
Measure	Dasatinib Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study Never received treatment	6
Overall Study Ineligible	2
Overall Study No KIT mutation	51

Baseline Characteristics

Dasatinib in Treating Patients With Locally Advanced or Metastatic Mucosal Melanoma, Acral Melanoma, or Vulvovaginal Melanoma That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dasatinib n=73 Participants Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Every 6 weeks; up to 5 years

Population: eligible and treated KIT-positive patients

Outcome measures

Outcome measures
Measure	Dasatinib n=22 Participants Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Objective Response Rate Among KIT-positive Patients	0.182 proportion of participants Interval 0.104 to 0.466

SECONDARY outcome

Timeframe: Every 6 weeks; up to 5 years

Population: Only eligible and treated patients with objective response (complete response or partial response) are included in this analysis.

Duration of response is defined as the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the first date that progressive disease is objectively documented, taking as reference the smallest measurements recorded since treatment started. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).

Outcome measures

Outcome measures
Measure	Dasatinib n=7 Participants Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Duration of Response for Dasatinib Monotherapy in This Patient Population	4.2 months Interval 0.0 to 17.1

SECONDARY outcome

Timeframe: Every 6 weeks; up to 5 years

Population: Only eligible and treated patients are included in this analysis.

Progression-free survival is defined as the time from registration to development of progressive disease. Patients without documented progressive disease are censored at the date of last disease assessment. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).

Outcome measures

Outcome measures
Measure	Dasatinib n=73 Participants Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Progression-free Survival	2.1 months Interval 1.5 to 2.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Every 6 weeks; up to 5 years

Outcome measures

Outcome data not reported

Adverse Events

Dasatinib

Serious events: 35 serious events

Other events: 54 other events

Deaths: 15 deaths

Serious adverse events

Serious adverse events
Measure	Dasatinib n=75 participants at risk Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	6.7% 5/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Cardiac disorders Chest pain - cardiac	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Cardiac disorders Heart failure	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Cardiac disorders Myocardial infarction	2.7% 2/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Cardiac disorders Cardiac disorders - Other, specify	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
General disorders Edema limbs	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
General disorders Fatigue	13.3% 10/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Gastrointestinal disorders Diarrhea	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Gastrointestinal disorders Ileus	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Gastrointestinal disorders Nausea	10.7% 8/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Gastrointestinal disorders Stomach pain	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Gastrointestinal disorders Vomiting	4.0% 3/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Infections and infestations Lung infection	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Infections and infestations Urinary tract infection	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Investigations Cardiac troponin I increased	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Investigations Cardiac troponin T increased	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Investigations INR increased	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Investigations Lipase increased	2.7% 2/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Investigations Lymphocyte count decreased	2.7% 2/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Investigations Neutrophil count decreased	4.0% 3/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Investigations Platelet count decreased	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Metabolism and nutrition disorders Anorexia	2.7% 2/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Metabolism and nutrition disorders Hyponatremia	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Nervous system disorders Nervous system disorders - Other	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Respiratory, thoracic and mediastinal disorders Cough	1.3% 1/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Respiratory, thoracic and mediastinal disorders Dyspnea	13.3% 10/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.7% 2/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.3% 4/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Vascular disorders Hypertension	2.7% 2/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.

Other adverse events

Other adverse events
Measure	Dasatinib n=75 participants at risk Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders Nausea	24.0% 18/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Gastrointestinal disorders Vomiting	8.0% 6/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Investigations Aspartate aminotransferase increased	10.7% 8/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Investigations Lipase increased	5.3% 4/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Investigations Lymphocyte count decreased	5.3% 4/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Investigations Neutrophil count decreased	6.7% 5/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Metabolism and nutrition disorders Anorexia	14.7% 11/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Musculoskeletal and connective tissue disorders Myalgia	8.0% 6/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Nervous system disorders Headache	9.3% 7/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.7% 8/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Respiratory, thoracic and mediastinal disorders Pleural effusion	13.3% 10/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Blood and lymphatic system disorders Anemia	32.0% 24/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
General disorders Edema limbs	6.7% 5/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
General disorders Fatigue	32.0% 24/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.
Gastrointestinal disorders Diarrhea	21.3% 16/75 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment Adverse events were evaluated among all treated patients, regardless of eligibility.

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 6176323012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60