Trial Outcomes & Findings for Phase I Study of MLN0128 and MLN8237 in Patients With Advanced Solid Tumors and Metastatic Triple-negative Breast Cancer (NCT NCT02719691)
NCT ID: NCT02719691
Last Updated: 2022-07-25
Results Overview
The maximum tolerated dose (MTD) will be defined as the highest dose level evaluated in which 0 or 1 patient out of 6 patients experiences dose limiting toxicity (DLT) in the combination of MLN0128 and Alisertib. Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2022-07-25
Participant Flow
This study had a dose escalation cohort followed by expansion cohorts. We had 65 patients consented and 18 patients were not eligible due to not meeting inclusion exclusion criteria. 1 subject withdrew by choice, 1 withdrew per Physician discretion..
Participant milestones
| Measure |
Dose Level 1: Alisertib 30 mg/MLN0128 1 mg
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 2: Alisertib 30 mg/MLN0128 2 mg
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 3: Alisertib 40 mg/MLN0128 2 mg
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 4: Alisertib 40 mg/MLN0128 3 mg
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
|
Dose-Expansion of Alisertib and MLN0128: Group 1
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
|
Dose-Expansion of Alisertib and MLN0128: Group 2
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
|
Pancreatic Cancer Cohort:
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
7
|
2
|
10
|
10
|
11
|
|
Overall Study
COMPLETED
|
3
|
4
|
6
|
2
|
10
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Dose Level 1: Alisertib 30 mg/MLN0128 1 mg
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 2: Alisertib 30 mg/MLN0128 2 mg
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 3: Alisertib 40 mg/MLN0128 2 mg
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 4: Alisertib 40 mg/MLN0128 3 mg
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
|
Dose-Expansion of Alisertib and MLN0128: Group 1
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
|
Dose-Expansion of Alisertib and MLN0128: Group 2
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
|
Pancreatic Cancer Cohort:
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
2 subjects were not analyzed as they were withdrawn from the study.
Baseline characteristics by cohort
| Measure |
Dose Level 1: Alisertib 30 mg/MLN0128 1 mg
n=3 Participants
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 2: Alisertib 30 mg/MLN0128 2 mg
n=4 Participants
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 3: Alisertib 40 mg/MLN0128 2 mg
n=6 Participants
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 3: Alisertib 40 mg/MLN0128 3 mg
n=2 Participants
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
|
Dose-Expansion of Alisertib and MLN0128: Group 1
n=10 Participants
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
|
Dose-Expansion of Alisertib and MLN0128: Group 2
n=9 Participants
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
|
Pancreatic Cancer Cohort
n=11 Participants
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=7 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=4 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=21 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=24 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
2 Participants
n=7 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
2 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
1 Participants
n=4 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
6 Participants
n=21 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
4 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
9 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
26 Participants
n=24 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
2 Participants
n=7 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
4 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
1 Participants
n=4 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
4 Participants
n=21 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
5 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
2 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
19 Participants
n=24 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
|
Age, Continuous
|
63.7 years
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
64.8 years
n=7 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
64.5 years
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
65.5 years
n=4 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
61.7 years
n=21 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
61.9 years
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
56.9 years
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
61.4 years
n=24 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
4 Participants
n=7 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
5 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
2 Participants
n=4 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
8 Participants
n=21 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
6 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
2 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
29 Participants
n=24 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=7 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
1 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=4 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
2 Participants
n=21 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
3 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
9 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
16 Participants
n=24 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=7 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
1 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=4 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
1 Participants
n=21 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
1 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
3 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
6 Participants
n=24 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
4 Participants
n=7 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
4 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
2 Participants
n=4 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
9 Participants
n=21 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
8 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
8 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
38 Participants
n=24 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=7 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
1 Participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=4 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=21 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
0 Participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
1 Participants
n=24 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
4 participants
n=7 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
6 participants
n=5 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
2 participants
n=4 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
10 participants
n=21 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
9 participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
11 participants
n=8 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
45 participants
n=24 Participants • 2 subjects were not analyzed as they were withdrawn from the study.
|
PRIMARY outcome
Timeframe: Up to 28 daysThe maximum tolerated dose (MTD) will be defined as the highest dose level evaluated in which 0 or 1 patient out of 6 patients experiences dose limiting toxicity (DLT) in the combination of MLN0128 and Alisertib. Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03.
Outcome measures
| Measure |
Dose-Escalation of Alisertib and MLN0128
n=15 Participants
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 2: Alisertib 30 mg/MLN0128 2 mg
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 3: Alisertib 40 mg/MLN0128 2 mg
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 4: Alisertib 40 mg/MLN0128 3 mg
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
|
Dose-Expansion of Alisertib and MLN0128: Group 1
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
|
Dose Expansion of Alisertib and MLN0128: Group 2
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
|
Pancreatic Cancer Cohort
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.
|
|---|---|---|---|---|---|---|---|
|
The Maximum Tolerated Dose (MTD) in the Combination of MLN0128 and Alisertib in Patients With Advanced Solid Tumors Measured by Treatment Adverse Events as Assessed by the CTCAE v4.03
alisertib
|
30 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Maximum Tolerated Dose (MTD) in the Combination of MLN0128 and Alisertib in Patients With Advanced Solid Tumors Measured by Treatment Adverse Events as Assessed by the CTCAE v4.03
TAK228
|
2 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At least 30 days after the last dose of MLN0128 or alisertibPopulation: Number of participants with at least one adverse event.
Adverse events will be tabulated by type and grade according to the NCI CTCAE v.4.03. Please see adverse events section.
Outcome measures
| Measure |
Dose-Escalation of Alisertib and MLN0128
n=3 Participants
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 2: Alisertib 30 mg/MLN0128 2 mg
n=4 Participants
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 3: Alisertib 40 mg/MLN0128 2 mg
n=7 Participants
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 4: Alisertib 40 mg/MLN0128 3 mg
n=2 Participants
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
|
Dose-Expansion of Alisertib and MLN0128: Group 1
n=10 Participants
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
|
Dose Expansion of Alisertib and MLN0128: Group 2
n=10 Participants
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
|
Pancreatic Cancer Cohort
n=11 Participants
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.
|
|---|---|---|---|---|---|---|---|
|
The Safety Profile and Tolerability of the Combination of MLN0128 and Alisertib in Adult Patients With Advanced Solid Tumors.
|
3 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
10 Participants
|
10 Participants
|
11 Participants
|
Adverse Events
Dose Level 1: Alisertib 30 mg/MLN0128 1 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 2: Alisertib 30 mg/MLN0128 2 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose Level 3: Alisertib 40 mg/MLN0128 2 mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Dose Level 4: Alisertib 40 mg/MLN0128 3 mg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose-Expansion of Alisertib and MLN0128: Group 1
Serious events: 3 serious events
Other events: 10 other events
Deaths: 7 deaths
Dose-Expansion of Alisertib and MLN0128: Group 2
Serious events: 4 serious events
Other events: 10 other events
Deaths: 9 deaths
Pancreatic Cohort
Serious events: 6 serious events
Other events: 11 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Dose Level 1: Alisertib 30 mg/MLN0128 1 mg
n=3 participants at risk
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 2: Alisertib 30 mg/MLN0128 2 mg
n=4 participants at risk
The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 2 mg given by mouth (PO) once daily with continuous dosing.
|
Dose Level 3: Alisertib 40 mg/MLN0128 2 mg
n=7 participants at risk
The starting dose of Alisertib is 40 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 2 mg given by mouth (PO) once daily with continuous dosing.
|
Dose Level 4: Alisertib 40 mg/MLN0128 3 mg
n=2 participants at risk
The starting dose of Alisertib is 40 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 3 mg given by mouth (PO) once daily with continuous dosing.
|
Dose-Expansion of Alisertib and MLN0128: Group 1
n=10 participants at risk
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
|
Dose-Expansion of Alisertib and MLN0128: Group 2
n=10 participants at risk
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
|
Pancreatic Cohort
n=11 participants at risk
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.
|
|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
33.3%
1/3 • Number of events 1 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
14.3%
1/7 • Number of events 1 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
Gastrointestinal disorders
dehydration
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
14.3%
1/7 • Number of events 1 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
General disorders
pain
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
14.3%
1/7 • Number of events 1 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
18.2%
2/11 • Number of events 3 • 3 years, 10 months
|
|
Infections and infestations
infection
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
General disorders
death progression of disease
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
hip fracture
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
Blood and lymphatic system disorders
thromboembolic event
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
|
Gastrointestinal disorders
gi bleed
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
|
Blood and lymphatic system disorders
Sepsis
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
14.3%
1/7 • Number of events 1 • 3 years, 10 months
|
50.0%
1/2 • Number of events 1 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
Congenital, familial and genetic disorders
vomitting
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
50.0%
1/2 • Number of events 1 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
Gastrointestinal disorders
ileus
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
50.0%
1/2 • Number of events 1 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
Nervous system disorders
encephalopathy
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
|
Gastrointestinal disorders
pancreatitis
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
Other adverse events
| Measure |
Dose Level 1: Alisertib 30 mg/MLN0128 1 mg
n=3 participants at risk
This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.
Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
|
Dose Level 2: Alisertib 30 mg/MLN0128 2 mg
n=4 participants at risk
The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 2 mg given by mouth (PO) once daily with continuous dosing.
|
Dose Level 3: Alisertib 40 mg/MLN0128 2 mg
n=7 participants at risk
The starting dose of Alisertib is 40 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 2 mg given by mouth (PO) once daily with continuous dosing.
|
Dose Level 4: Alisertib 40 mg/MLN0128 3 mg
n=2 participants at risk
The starting dose of Alisertib is 40 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 3 mg given by mouth (PO) once daily with continuous dosing.
|
Dose-Expansion of Alisertib and MLN0128: Group 1
n=10 participants at risk
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
|
Dose-Expansion of Alisertib and MLN0128: Group 2
n=10 participants at risk
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
|
Pancreatic Cohort
n=11 participants at risk
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.
|
|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 1 • 3 years, 10 months
|
25.0%
1/4 • Number of events 1 • 3 years, 10 months
|
14.3%
1/7 • Number of events 1 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
30.0%
3/10 • Number of events 3 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
14.3%
1/7 • Number of events 3 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
|
Blood and lymphatic system disorders
Alkaline Phosphatase
|
0.00%
0/3 • 3 years, 10 months
|
25.0%
1/4 • Number of events 1 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
18.2%
2/11 • Number of events 2 • 3 years, 10 months
|
|
General disorders
Anorexia
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
57.1%
4/7 • Number of events 4 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
20.0%
2/10 • Number of events 2 • 3 years, 10 months
|
20.0%
2/10 • Number of events 2 • 3 years, 10 months
|
36.4%
4/11 • Number of events 4 • 3 years, 10 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
14.3%
1/7 • Number of events 1 • 3 years, 10 months
|
50.0%
1/2 • Number of events 1 • 3 years, 10 months
|
20.0%
2/10 • Number of events 2 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
9.1%
1/11 • Number of events 2 • 3 years, 10 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 3 years, 10 months
|
50.0%
2/4 • Number of events 2 • 3 years, 10 months
|
28.6%
2/7 • Number of events 2 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
40.0%
4/10 • Number of events 9 • 3 years, 10 months
|
20.0%
2/10 • Number of events 2 • 3 years, 10 months
|
63.6%
7/11 • Number of events 8 • 3 years, 10 months
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • 3 years, 10 months
|
50.0%
2/4 • Number of events 3 • 3 years, 10 months
|
42.9%
3/7 • Number of events 3 • 3 years, 10 months
|
100.0%
2/2 • Number of events 6 • 3 years, 10 months
|
40.0%
4/10 • Number of events 4 • 3 years, 10 months
|
70.0%
7/10 • Number of events 7 • 3 years, 10 months
|
63.6%
7/11 • Number of events 9 • 3 years, 10 months
|
|
Endocrine disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1 • 3 years, 10 months
|
25.0%
1/4 • Number of events 1 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
50.0%
1/2 • Number of events 1 • 3 years, 10 months
|
30.0%
3/10 • Number of events 4 • 3 years, 10 months
|
20.0%
2/10 • Number of events 3 • 3 years, 10 months
|
27.3%
3/11 • Number of events 3 • 3 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Mucositis
|
0.00%
0/3 • 3 years, 10 months
|
25.0%
1/4 • Number of events 2 • 3 years, 10 months
|
14.3%
1/7 • Number of events 1 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
50.0%
5/10 • Number of events 12 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
85.7%
6/7 • Number of events 7 • 3 years, 10 months
|
50.0%
1/2 • Number of events 1 • 3 years, 10 months
|
20.0%
2/10 • Number of events 2 • 3 years, 10 months
|
30.0%
3/10 • Number of events 3 • 3 years, 10 months
|
54.5%
6/11 • Number of events 8 • 3 years, 10 months
|
|
Blood and lymphatic system disorders
Neutrophil Count Decreased
|
0.00%
0/3 • 3 years, 10 months
|
50.0%
2/4 • Number of events 5 • 3 years, 10 months
|
57.1%
4/7 • Number of events 7 • 3 years, 10 months
|
50.0%
1/2 • Number of events 1 • 3 years, 10 months
|
10.0%
1/10 • Number of events 2 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
27.3%
3/11 • Number of events 8 • 3 years, 10 months
|
|
Blood and lymphatic system disorders
Platelet Count Decreased
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
28.6%
2/7 • Number of events 3 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
10.0%
1/10 • Number of events 3 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
|
Blood and lymphatic system disorders
Pruritis
|
33.3%
1/3 • Number of events 1 • 3 years, 10 months
|
25.0%
1/4 • Number of events 1 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
10.0%
1/10 • Number of events 2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
18.2%
2/11 • Number of events 2 • 3 years, 10 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
14.3%
1/7 • Number of events 1 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
General disorders
Headache
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
General disorders
Abdominal Pain
|
33.3%
1/3 • Number of events 1 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
28.6%
2/7 • Number of events 2 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
30.0%
3/10 • Number of events 4 • 3 years, 10 months
|
20.0%
2/10 • Number of events 2 • 3 years, 10 months
|
54.5%
6/11 • Number of events 7 • 3 years, 10 months
|
|
Blood and lymphatic system disorders
Alanine Aminotransferase Increased
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
18.2%
2/11 • Number of events 2 • 3 years, 10 months
|
|
Blood and lymphatic system disorders
Ascites
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
18.2%
2/11 • Number of events 2 • 3 years, 10 months
|
|
Blood and lymphatic system disorders
AST Increase
|
0.00%
0/3 • 3 years, 10 months
|
25.0%
1/4 • Number of events 2 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
20.0%
2/10 • Number of events 2 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
18.2%
2/11 • Number of events 2 • 3 years, 10 months
|
|
General disorders
Back Pain
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
28.6%
2/7 • Number of events 2 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
10.0%
1/10 • Number of events 1 • 3 years, 10 months
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
14.3%
1/7 • Number of events 1 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
|
Infections and infestations
Lung Infection
|
0.00%
0/3 • 3 years, 10 months
|
0.00%
0/4 • 3 years, 10 months
|
14.3%
1/7 • Number of events 1 • 3 years, 10 months
|
0.00%
0/2 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place