Trial Outcomes & Findings for Imatinib Mesylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery (NCT NCT00470470)
NCT ID: NCT00470470
Last Updated: 2014-12-23
Results Overview
Response will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon two-stage minimax design will be employed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Every 6 weeks for the first 3 courses and then every 12 weeks thereafter
Results posted on
2014-12-23
Participant Flow
Protocol Open to Accrual: 04/05/2007 Protocol Closed to Accrual: 11/23/2010 Recruitment Location is the medical clinic
Participant milestones
| Measure |
Treatment (Enzyme Inhibitor Therapy)
Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment (Enzyme Inhibitor Therapy)
Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
2
|
|
Overall Study
Not treated
|
1
|
Baseline Characteristics
Imatinib Mesylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=30 Participants
Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 27.57716447 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks for the first 3 courses and then every 12 weeks thereafterResponse will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon two-stage minimax design will be employed.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=25 Participants
Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Objective Response Rate
Complete Response
|
1 participants
|
|
Objective Response Rate
Partial Response
|
3 participants
|
|
Objective Response Rate
Stable Disease
|
14 participants
|
|
Objective Response Rate
Progression of Disease
|
7 participants
|
SECONDARY outcome
Timeframe: Time from the treatment start to the date of disease progressionProgression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. Time to progression will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=25 Participants
Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Time to Progression
|
12 weeks
Interval 6.0 to 18.0
|
Adverse Events
Treatment (Enzyme Inhibitor Therapy)
Serious events: 18 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=30 participants at risk
Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Serum amylase increased
|
3.3%
1/30 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Creatinine increased
|
10.0%
3/30 • Number of events 3
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Death (Disease progression)
|
20.0%
6/30 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
2/30 • Number of events 2
|
|
General disorders
Edema (Head and Neck)
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Fatigue
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Fever
|
3.3%
1/30 • Number of events 1
|
|
Reproductive system and breast disorders
Gynecomastia
|
3.3%
1/30 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
4/30 • Number of events 4
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.3%
1/30 • Number of events 1
|
|
Renal and urinary disorders
Hemorrhage-urinary tract
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Infection-Urinary tract
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Lipase increased
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
16.7%
5/30 • Number of events 5
|
|
Renal and urinary disorders
Obstruction-Ureter
|
3.3%
1/30 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
2/30 • Number of events 2
|
|
Investigations
Platelet count decreased
|
3.3%
1/30 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
3.3%
1/30 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamation
|
3.3%
1/30 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.3%
1/30 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
3.3%
1/30 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
6.7%
2/30 • Number of events 2
|
|
Nervous system disorders
Depressed level of consciousness
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
4/30 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
1/30 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=30 participants at risk
Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
imatinib mesylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
2/30 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
43.3%
13/30 • Number of events 93
|
|
Investigations
Creatinine increased
|
6.7%
2/30 • Number of events 15
|
|
General disorders
Edema-limbs
|
6.7%
2/30 • Number of events 2
|
|
General disorders
Fatigue
|
26.7%
8/30 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.7%
2/30 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
3/30 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
3/30 • Number of events 6
|
|
Investigations
Lymphocyte count decreased
|
23.3%
7/30 • Number of events 27
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
2/30 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
6/30 • Number of events 8
|
|
Investigations
White blood cell decreased
|
10.0%
3/30 • Number of events 3
|
Additional Information
Dr. Richard Carvajal
Memorial Sloan-Kettering Cancer Center
Phone: 646-888-4161
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60