Trial Outcomes & Findings for Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma (NCT NCT02340156)
NCT ID: NCT02340156
Last Updated: 2021-03-03
Results Overview
The 6 month progression-free survival (PFS) was evaluated using RANO Response Criteria.
TERMINATED
PHASE2
1 participants
6 months
2021-03-03
Participant Flow
Recruitment was opened in Houston, Texas, USA and Taichung, Taiwan.
Only one arm in this study.
Participant milestones
| Measure |
SGT-53 With Temozolomide
SGT-53, at 3.6 mg DNA/infusion, will be administered twice weekly in a 28 day cycle starting on Day 1 (cycle 1), Day 29 (cycle 2) and Day 57 (cycle 3). Temozolomide (TMZ) will be administered by mouth daily on days 9-13 of each cycle.
If SGT-53-related toxicity occurs, the dose of SGT-53 will be de-escalated to 2.4 or 1.2 mg DNA/infusion when appropriate.
Temozolomide: In cycle 1, the dose of TMZ will be 150 mg/m². If the TMZ-related toxicities are tolerated in cycle 1, the dose of TMZ will be escalated to 200 mg/m² for cycle 2 and beyond. If TMZ-related toxicity occurs, the dose if TMZ will be de-escalated to 125 mg/m² (dose level -1), 100 mg/m² (dose level -2) or 75 mg/m² (dose level -3) when appropriate.
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|---|---|
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
SGT-53 With Temozolomide
n=1 Participants
SGT-53, at 3.6 mg DNA/infusion, will be administered twice weekly in a 28 day cycle starting on Day 1 (cycle 1), Day 29 (cycle 2) and Day 57 (cycle 3). Temozolomide (TMZ) will be administered by mouth daily on days 9-13 of each cycle.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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1 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age, Continuous
|
60 years
n=5 Participants
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|
Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
Taiwan
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1 participants
n=5 Participants
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Number of Relapse
First
|
1 Participants
n=5 Participants
|
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Number of Relapse
Second
|
0 Participants
n=5 Participants
|
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Number of Relapse
Third
|
0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 6 monthsPopulation: The number of participant was too small to analyze.
The 6 month progression-free survival (PFS) was evaluated using RANO Response Criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later, approximately 90 days.Population: Adverse events that were grade 3 or above
The safety of the combination of SGT-53 and Temozolomide was assessed by analysis of adverse experiences, clinical laboratory tests and physical examinations.
Outcome measures
| Measure |
SGT-53 With Temozolomide
n=1 Participants
SGT-53, at 3.6 mg DNA/infusion, was administered twice weekly in a 28 day cycle starting on Day 1 (cycle 1), Day 29 (cycle 2) and Day 57 (cycle 3). Temozolomide (TMZ) was administered by mouth daily on days 9-13 of each cycle.
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|---|---|
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Incidence of Treatment-Emergent Adverse Events
Seizure
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1 Participants
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Incidence of Treatment-Emergent Adverse Events
Electrocardiogram QT corrected interval prolonged
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1 Participants
|
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Incidence of Treatment-Emergent Adverse Events
Skin ulceration
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1 Participants
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SECONDARY outcome
Timeframe: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.Population: The number of participant was too small to analyze.
Progression-free survival is defined as the time from the date of enrollment to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurs earlier. Subjects who do not have disease progression or have not died will be censored at the date of the last tumor assessment on or prior to the clinical cutoff.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of registration until the date of death from any cause, assessed up to 180 months.Population: The number of participant was too small to analyze.
Overall survival is defined as the time from the date of enrollment to the date of death from all causes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.Population: The number of participant was too small to analyze.
The anti-tumor activity of the combination of SGT-53 and Temozolomide was determined based upon the RANO criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 daysPopulation: The number of participant was too small to analyze.
Flow cytometry or histological examination was used to determine the level of apoptosis induced by SGT-53 in tumors resected 3 days after the first SGT-53 infusion (optional procedure)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 daysPopulation: The number of participant was too small to analyze.
As an indicator of nanoparticle delivery to the tumors, DNA PCR was used to determine the presence of SGT-53 delivered exogenous wt p53 in the tumors. This analysis will be performed on any tumors resected 3 days after the first SGT-53 infusion (optional procedure)
Outcome measures
Outcome data not reported
Adverse Events
SGT-53 With Temozolomide
Serious adverse events
| Measure |
SGT-53 With Temozolomide
n=1 participants at risk
SGT-53, at 3.6 mg DNA/infusion, was administered twice weekly in a 28 day cycle starting on Day 1 (cycle 1), Day 29 (cycle 2) and Day 57 (cycle 3). Temozolomide (TMZ) was administered by mouth daily on days 9-13 of each cycle.
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|---|---|
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Nervous system disorders
Seizure
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100.0%
1/1 • Number of events 1 • Study drug initiation through 30 days after the last dose of study drug or End of Study, whichever is later, approximately 90 days.
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Other adverse events
| Measure |
SGT-53 With Temozolomide
n=1 participants at risk
SGT-53, at 3.6 mg DNA/infusion, was administered twice weekly in a 28 day cycle starting on Day 1 (cycle 1), Day 29 (cycle 2) and Day 57 (cycle 3). Temozolomide (TMZ) was administered by mouth daily on days 9-13 of each cycle.
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|---|---|
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Investigations
Electrocardiogram QT corrected interval prolonged
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100.0%
1/1 • Number of events 1 • Study drug initiation through 30 days after the last dose of study drug or End of Study, whichever is later, approximately 90 days.
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Skin and subcutaneous tissue disorders
Skin ulceration
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100.0%
1/1 • Number of events 1 • Study drug initiation through 30 days after the last dose of study drug or End of Study, whichever is later, approximately 90 days.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place