Trial Outcomes & Findings for Phase 0 Analysis of Ixazomib (MLN9708) in Patients With Glioblastoma (NCT NCT02630030)
NCT ID: NCT02630030
Last Updated: 2021-03-26
Results Overview
The relationship between patient's demographic, tumor and drug concentration results will be assessed with Pearson's correlation coefficient and tested with Wald's test. In addition, the mean and standard error of the concentrations will be estimated using a random-effects model to account for the within-patient correlation of the tumor biopsy samples. Given the limited number of observations, a relatively simple covariance matrix (e.g. compound symmetry) will be assumed.
COMPLETED
EARLY_PHASE1
3 participants
At time of surgery, approximately 3 hours
2021-03-26
Participant Flow
Participant milestones
| Measure |
Ixazomib
Patients receive ixazomib PO 3 hours before surgery.
Ixazomib: Given PO
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 0 Analysis of Ixazomib (MLN9708) in Patients With Glioblastoma
Baseline characteristics by cohort
| Measure |
Ixazomib
n=3 Participants
Patients receive ixazomib PO 3 hours before surgery.
Ixazomib: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
50.33 Years
STANDARD_DEVIATION NA • n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At time of surgery, approximately 3 hoursPopulation: Each participant's sample was analyzed separately. For participant 3, 3 samples were collected and analyzed in order to account for intratumor variability
The relationship between patient's demographic, tumor and drug concentration results will be assessed with Pearson's correlation coefficient and tested with Wald's test. In addition, the mean and standard error of the concentrations will be estimated using a random-effects model to account for the within-patient correlation of the tumor biopsy samples. Given the limited number of observations, a relatively simple covariance matrix (e.g. compound symmetry) will be assumed.
Outcome measures
| Measure |
Ixazomib
n=3 Participants
Patients receive ixazomib PO 3 hours before surgery.
Ixazomib: Given PO
|
|---|---|
|
Concentration of Ixazomib in Tumor Tissue
Participant 1
|
7.88 ng/g
|
|
Concentration of Ixazomib in Tumor Tissue
Participant 2
|
2.03 ng/g
|
|
Concentration of Ixazomib in Tumor Tissue
Participant 3 Sample 1
|
4.17 ng/g
|
|
Concentration of Ixazomib in Tumor Tissue
Participant 3 Sample 2
|
2.70 ng/g
|
|
Concentration of Ixazomib in Tumor Tissue
Participant 3 Sample 3
|
3.25 ng/g
|
PRIMARY outcome
Timeframe: At time of surgery, approximately 3 hoursPopulation: Each participant's plasma concentration was analyzed separately.
The relationship between patient's demographic, tumor and drug concentration results will be assessed with Pearson's correlation coefficient and tested with Wald's test. In addition, the mean and standard error of the concentrations will be estimated using a random-effects model to account for the within-patient correlation of the tumor biopsy samples. Given the limited number of observations, a relatively simple covariance matrix (e.g. compound symmetry) will be assumed.
Outcome measures
| Measure |
Ixazomib
n=3 Participants
Patients receive ixazomib PO 3 hours before surgery.
Ixazomib: Given PO
|
|---|---|
|
Concentration of Ixazomib in Tumor Tissue
Participant 1
|
21.8 ng/g
|
|
Concentration of Ixazomib in Tumor Tissue
Participant 2
|
18.0 ng/g
|
|
Concentration of Ixazomib in Tumor Tissue
Participant 3
|
36.2 ng/g
|
PRIMARY outcome
Timeframe: At the time of surgery, approximately 3 hoursSafety was assessed with routine postoperative laboratory, vital sign, neurologic exam, and imaging studies through the day of surgery to staple or suture removal. This data was collected and any adverse events graded and their relationship to ixazomib administration determined.
Outcome measures
| Measure |
Ixazomib
n=3 Participants
Patients receive ixazomib PO 3 hours before surgery.
Ixazomib: Given PO
|
|---|---|
|
Number of Patients With Safety and Tolerability of Ixazomib
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 30 daysThe National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) was used to stratify any adverse patient response to ixazomib. There were no clinically relevant adverse events as a result of ixazomib administration.
Outcome measures
| Measure |
Ixazomib
n=3 Participants
Patients receive ixazomib PO 3 hours before surgery.
Ixazomib: Given PO
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
|
3 Participants
|
Adverse Events
Ixazomib
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ixazomib
n=3 participants at risk
Patients receive ixazomib PO 3 hours before surgery.
Ixazomib: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Adverse events collected through study completion, 30 days after study drug administration.
|
|
Immune system disorders
Thrombocytopenia
|
33.3%
1/3 • Adverse events collected through study completion, 30 days after study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Dysarthria
|
33.3%
1/3 • Adverse events collected through study completion, 30 days after study drug administration.
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Adverse events collected through study completion, 30 days after study drug administration.
|
|
General disorders
Lipase
|
33.3%
1/3 • Adverse events collected through study completion, 30 days after study drug administration.
|
|
General disorders
Confusion
|
66.7%
2/3 • Adverse events collected through study completion, 30 days after study drug administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place