Trial Outcomes & Findings for Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide (NCT NCT00629343)
NCT ID: NCT00629343
Last Updated: 2025-06-05
Results Overview
Maximum tolerated dose of temozolomide when used in combination with azacitidine
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Up to 26 weeks for each dosing cohort
Results posted on
2025-06-05
Participant Flow
27 participants signed a consent form and four were determined to be ineligible, resulting in 23 assigned to treatment.
Participant milestones
| Measure |
Azacitidine 25mg
Cohort 1: Participants received 25 mg Azacitidine sub-cutaneously, and 200 mg/m2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
|
Azacitidine 50 mg
Cohort 2: Participants received 50 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
|
Azacitidine 75 mg
Cohort 3: Participants received 75 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
|
|---|---|---|---|
|
Dose Level 1: Azacitidine 25mg
STARTED
|
3
|
0
|
0
|
|
Dose Level 1: Azacitidine 25mg
COMPLETED
|
3
|
0
|
0
|
|
Dose Level 1: Azacitidine 25mg
NOT COMPLETED
|
0
|
0
|
0
|
|
Dose Level 2: Azacitidine 50 mg
STARTED
|
0
|
3
|
0
|
|
Dose Level 2: Azacitidine 50 mg
COMPLETED
|
0
|
3
|
0
|
|
Dose Level 2: Azacitidine 50 mg
NOT COMPLETED
|
0
|
0
|
0
|
|
Dose Level 3: Azacitidine 75mg
STARTED
|
0
|
0
|
17
|
|
Dose Level 3: Azacitidine 75mg
COMPLETED
|
0
|
0
|
17
|
|
Dose Level 3: Azacitidine 75mg
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide
Baseline characteristics by cohort
| Measure |
Azacitidine 25 mg
n=3 Participants
Cohort 1: Participants received 25 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
|
Azacitidine 50 mg
n=3 Participants
Cohort 2: Participants received 50 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
|
Azacitidine 75 mg
n=17 Participants
Cohort 3: Participants received 75 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
≥ 18 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Unknown
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 26 weeks for each dosing cohortMaximum tolerated dose of temozolomide when used in combination with azacitidine
Outcome measures
| Measure |
Treatment
n=23 Participants
Subjects will receive azacitidine in combination with temozolomide
Azacitidine: Azacitidine will be delivered sub-cutaneously for 5 days
Temozolomide: Temozolomide will be given starting on day 8 for 5 days at a dose of 200 mg/m2 po qd x 5 days
|
|---|---|
|
Maximum Tolerated Dose of Temozolomide
|
200 mg/m^2
|
PRIMARY outcome
Timeframe: Up to 26 weeks for each dosing cohortMaximum tolerated dose of azacitidine when used in combination with temozolomide
Outcome measures
| Measure |
Treatment
n=23 Participants
Subjects will receive azacitidine in combination with temozolomide
Azacitidine: Azacitidine will be delivered sub-cutaneously for 5 days
Temozolomide: Temozolomide will be given starting on day 8 for 5 days at a dose of 200 mg/m2 po qd x 5 days
|
|---|---|
|
Maximum Tolerated Dose of Azacitidine
|
75 mg/m^2
|
Adverse Events
Azacitidine 25 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Azacitidine 50 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Azacitidine 75 mg
Serious events: 15 serious events
Other events: 0 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Azacitidine 25 mg
n=3 participants at risk
Cohort 1: Participants received 25 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
|
Azacitidine 50 mg
n=3 participants at risk
Cohort 2: Participants received 50 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
|
Azacitidine 75 mg
n=17 participants at risk
Cohort 3: Participants received 75 mg Azacitidine sub-cutaneously, and 200 mg/m\^2 Temozolomide orally; both once a day on Days 1 - 5 of a 28-day cycle.
|
|---|---|---|---|
|
General disorders
Death due to progression of disease
|
0.00%
0/3 • up to 59 months after enrollment
|
0.00%
0/3 • up to 59 months after enrollment
|
88.2%
15/17 • up to 59 months after enrollment
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place