Trial Outcomes & Findings for Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma (NCT NCT00090987)
NCT ID: NCT00090987
Last Updated: 2018-06-06
Results Overview
Clinical response = Complete Response (absence of residual disease) or Partial Response defined as no new lesions (skin or oral), or no new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions); AND 50% or greater decrease in the number of lesions lasting for \>4 weeks; OR Complete flattening of at least 50% of all previously raised lesions OR A 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions
COMPLETED
PHASE2
30 participants
20-24 weeks
2018-06-06
Participant Flow
Date of Recruitment: August 4, 2005 to August 29, 2007 at 12 AMC clinical centers
Three patients withdrew from the study before receiving treatment.
Participant milestones
| Measure |
Imatinib Mesylate (Gleevec)
Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
Imatinib Mesylate (Gleevec)
Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Lack of Efficacy
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
alternative therapy
|
1
|
|
Overall Study
Non-compliance
|
4
|
|
Overall Study
Incarcerated
|
1
|
Baseline Characteristics
Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma
Baseline characteristics by cohort
| Measure |
Imatinib Mesylate (Gleevec)
n=30 Participants
Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20-24 weeksClinical response = Complete Response (absence of residual disease) or Partial Response defined as no new lesions (skin or oral), or no new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions); AND 50% or greater decrease in the number of lesions lasting for \>4 weeks; OR Complete flattening of at least 50% of all previously raised lesions OR A 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions
Outcome measures
| Measure |
Imatinib Mesylate (Gleevec)
n=30 Participants
Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
|
|---|---|
|
Proportion of Patients Who Achieve a Clinical Response
|
0.33 proportion
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsMutations in the juxtamembrane or kinase membrane of the c-kit or PDGF receptors at baseline or time of progression
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
Adverse Events
Imatinib Mesylate (Gleevec)
Serious adverse events
| Measure |
Imatinib Mesylate (Gleevec)
n=30 participants at risk
Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
|
|---|---|
|
Blood and lymphatic system disorders
Hemorrhage
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Infection
|
3.3%
1/30 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malignancy
|
3.3%
1/30 • Number of events 1
|
Other adverse events
| Measure |
Imatinib Mesylate (Gleevec)
n=30 participants at risk
Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
|
|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT
|
6.7%
2/30 • Number of events 2
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
10.0%
3/30 • Number of events 3
|
|
Metabolism and nutrition disorders
Amylase
|
10.0%
3/30 • Number of events 10
|
|
Gastrointestinal disorders
Anorexia
|
10.0%
3/30 • Number of events 3
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow
|
6.7%
2/30 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Bruising
|
6.7%
2/30 • Number of events 2
|
|
Metabolism and nutrition disorders
CPK
|
10.0%
3/30 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
3/30 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin, other
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
6/30 • Number of events 7
|
|
Nervous system disorders
Dizziness
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
2/30 • Number of events 2
|
|
Blood and lymphatic system disorders
Edema, limb
|
20.0%
6/30 • Number of events 8
|
|
General disorders
Fatigue
|
16.7%
5/30 • Number of events 8
|
|
Gastrointestinal disorders
Gastrointestinal, other
|
6.7%
2/30 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin
|
20.0%
6/30 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
16.7%
5/30 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.3%
4/30 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
2/30 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.3%
4/30 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
13.3%
4/30 • Number of events 9
|
|
General disorders
Insomnia
|
6.7%
2/30 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
13.3%
4/30 • Number of events 6
|
|
Metabolism and nutrition disorders
Metabolic/laboratory other
|
10.0%
3/30 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
33.3%
10/30 • Number of events 14
|
|
Blood and lymphatic system disorders
Neutrophil Count
|
13.3%
4/30 • Number of events 7
|
|
Gastrointestinal disorders
Pain, abdominal
|
6.7%
2/30 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain, back
|
6.7%
2/30 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pain, chest
|
10.0%
3/30 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain, extremity
|
20.0%
6/30 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain, muscle
|
10.0%
3/30 • Number of events 4
|
|
Blood and lymphatic system disorders
Platelets
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
Taste Alteration
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
6/30 • Number of events 9
|
|
Gastrointestinal disorders
Abdominal bloating
|
6.7%
2/30 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place