Trial Outcomes & Findings for Study of Ixazomib With Pegylated IFN-alpha 2b (pIFN) in Metastatic Renal Cell Carcinoma (mRCC) (NCT NCT02447887)
NCT ID: NCT02447887
Last Updated: 2019-09-26
Results Overview
* Grade 3 nausea or Grade 3 vomiting ≤ 72 hours that recovers to grade 0-2 with maximal antiemetic therapy. * Grade 3 diarrhea that resolves to grade 0-2 with loperamide or diphenoxylate/atropine within 48 hours. * Grade 3 hypercholesterolemia, hypertriglyceridemia, hyperglycemia or hypophosphatemia that resolves to grade 0-2 with medical management. * Transient electrolyte abnormalities lasting ≤ 1 week.
TERMINATED
PHASE1/PHASE2
3 participants
Up to week 8
2019-09-26
Participant Flow
Participant milestones
| Measure |
Ixazomib and Pegylated IFN Alfa - 2b
Ixazomib capsules and pegylated IFN alfa 2b injections weekly. Ixazomib will be taken for the last 3 weeks of 28 day cycle. Pegylated IFN alfa 2b injection will be administered weekly, each week of the 28 day cycle.
Ixazomib: The prescribed administration of ixazomib doses in this study is 1.5-4.0 mg ixazomib weekly for 3 out of 4 weeks in each cycle (1 cycle=28 days).
Pegylated IFN-alpha 2b: Weekly injection
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Ixazomib and Pegylated IFN Alfa - 2b
Ixazomib capsules and pegylated IFN alfa 2b injections weekly. Ixazomib will be taken for the last 3 weeks of 28 day cycle. Pegylated IFN alfa 2b injection will be administered weekly, each week of the 28 day cycle.
Ixazomib: The prescribed administration of ixazomib doses in this study is 1.5-4.0 mg ixazomib weekly for 3 out of 4 weeks in each cycle (1 cycle=28 days).
Pegylated IFN-alpha 2b: Weekly injection
|
|---|---|
|
Overall Study
Study was terminated
|
3
|
Baseline Characteristics
Study of Ixazomib With Pegylated IFN-alpha 2b (pIFN) in Metastatic Renal Cell Carcinoma (mRCC)
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to week 8Population: Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.
* Grade 3 nausea or Grade 3 vomiting ≤ 72 hours that recovers to grade 0-2 with maximal antiemetic therapy. * Grade 3 diarrhea that resolves to grade 0-2 with loperamide or diphenoxylate/atropine within 48 hours. * Grade 3 hypercholesterolemia, hypertriglyceridemia, hyperglycemia or hypophosphatemia that resolves to grade 0-2 with medical management. * Transient electrolyte abnormalities lasting ≤ 1 week.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to week 8Population: Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to week 8Population: Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to week 8Population: Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 28 DaysPopulation: Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 28 DaysPopulation: Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At week 8Population: Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At week 16Population: Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 8Population: Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 16Population: Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.
Outcome measures
Outcome data not reported
Adverse Events
Ixazomib and Pegylated IFN Alfa - 2b
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place