Trial Outcomes & Findings for Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients (NCT NCT01031628)
NCT ID: NCT01031628
Last Updated: 2013-09-09
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
5 participants
Primary outcome timeframe
Every 3 months
Results posted on
2013-09-09
Participant Flow
Participant milestones
| Measure |
400 mg for Patients With Imatinib Blood Levels < 1100
Patients with imatinib trough blood levels less than 1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
600 or 800 mg for Patients With Imatinib Blood Levels < 1100
Patients with imatinib trough blood levels less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL
Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
400 mg for Patients With Imatinib Blood Levels ≥ 1100
Patients with imatinib trough blood levels ≥1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
400, 600 or 800 mg for Patients With Exon 9 Mutation Tumors
Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
3
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
3
|
0
|
Reasons for withdrawal
| Measure |
400 mg for Patients With Imatinib Blood Levels < 1100
Patients with imatinib trough blood levels less than 1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
600 or 800 mg for Patients With Imatinib Blood Levels < 1100
Patients with imatinib trough blood levels less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL
Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
400 mg for Patients With Imatinib Blood Levels ≥ 1100
Patients with imatinib trough blood levels ≥1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
400, 600 or 800 mg for Patients With Exon 9 Mutation Tumors
Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
|---|---|---|---|---|
|
Overall Study
Study terminated early
|
0
|
1
|
3
|
0
|
Baseline Characteristics
Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients
Baseline characteristics by cohort
| Measure |
Arm A
Patients with blood level less than 1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
Arm B
n=1 Participants
Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL
Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
Arm C
n=3 Participants
Patients with blood level ≥1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
Arm D
Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Categorical
<=18 years
|
—
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
|
Age Categorical
Between 18 and 65 years
|
—
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
—
|
3 participants
n=21 Participants
|
|
Age Categorical
>=65 years
|
—
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
1 participants
n=21 Participants
|
|
Age Continuous
|
—
|
71 years
n=7 Participants
|
56.7 years
STANDARD_DEVIATION 8.39 • n=5 Participants
|
—
|
60.25 years
STANDARD_DEVIATION 7.68 • n=21 Participants
|
|
Gender
Female
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
—
|
2 participants
n=21 Participants
|
|
Gender
Male
|
—
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
—
|
2 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
—
|
4 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Every 3 monthsPopulation: Data were not collected or analyzed due to early termination.
Outcome measures
Outcome data not reported
Adverse Events
Arm A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm C
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A
Patients with blood level less than 1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
Arm B
n=1 participants at risk
Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL
Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
Arm C
n=3 participants at risk
Patients with blood level ≥1100 will continue imatinib 400 mg daily
Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
Arm D
Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
|
|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
—
0/0
|
100.0%
1/1 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
—
0/0
|
|
General disorders
Fatigue
|
—
0/0
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
—
0/0
|
|
Gastrointestinal disorders
Nausea
|
—
0/0
|
100.0%
1/1 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
—
0/0
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0
|
0.00%
0/1
|
66.7%
2/3 • Number of events 2
|
—
0/0
|
|
Nervous system disorders
Dysguesia
|
—
0/0
|
100.0%
1/1 • Number of events 1
|
0.00%
0/3
|
—
0/0
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
—
0/0
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
—
0/0
|
|
Nervous system disorders
Headache
|
—
0/0
|
100.0%
1/1 • Number of events 1
|
0.00%
0/3
|
—
0/0
|
|
General disorders
Pain
|
—
0/0
|
0.00%
0/1
|
33.3%
1/3 • Number of events 2
|
—
0/0
|
|
Infections and infestations
Skin Infection
|
—
0/0
|
100.0%
1/1 • Number of events 2
|
0.00%
0/3
|
—
0/0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place