Trial Outcomes & Findings for Study of RP-6306 With FOLFIRI in Advanced Solid Tumors (NCT NCT05147350)
NCT ID: NCT05147350
Last Updated: 2025-12-05
Results Overview
Incidence of grade 3 and above Treatment Related Emergent Adverse Events (TRAEs)
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
Start of treatment to 30 days post last dose. up to 1.5 years
Results posted on
2025-12-05
Participant Flow
Participant milestones
| Measure |
40 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
40 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
120 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
120 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
180 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
180 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
240 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
240 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
60 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
60 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
80 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
80 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
80 mg BID RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
80 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
120 mg QD RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
120 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
9
|
4
|
7
|
3
|
4
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
9
|
3
|
7
|
3
|
3
|
5
|
Reasons for withdrawal
| Measure |
40 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
40 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
120 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
120 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
180 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
180 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
240 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
240 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
60 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
60 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
80 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
80 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
80 mg BID RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
80 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
120 mg QD RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
120 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
2
|
3
|
3
|
2
|
2
|
1
|
1
|
3
|
|
Overall Study
Sponsor Decision to Terminate Study
|
0
|
0
|
1
|
0
|
4
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
3
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Other Reasons
|
0
|
0
|
2
|
0
|
0
|
2
|
1
|
1
|
Baseline Characteristics
Study of RP-6306 With FOLFIRI in Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
40 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=2 Participants
40 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
120 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=3 Participants
120 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
180 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=9 Participants
180 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
240 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=4 Participants
240 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
60 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
n=7 Participants
60 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
80 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
n=3 Participants
80 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
80 mg BID RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
n=4 Participants
80 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
120 mg QD RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
n=6 Participants
120 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Gene Type
CCNE1
|
0 participants
n=37 Participants
|
0 participants
n=37 Participants
|
4 participants
n=74 Participants
|
0 participants
n=267 Participants
|
2 participants
n=272 Participants
|
0 participants
n=6 Participants
|
2 participants
n=36 Participants
|
4 participants
n=18 Participants
|
12 participants
n=1946 Participants
|
|
Gene Type
FBXW7
|
2 participants
n=37 Participants
|
3 participants
n=37 Participants
|
5 participants
n=74 Participants
|
4 participants
n=267 Participants
|
5 participants
n=272 Participants
|
3 participants
n=6 Participants
|
2 participants
n=36 Participants
|
2 participants
n=18 Participants
|
26 participants
n=1946 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=1946 Participants
|
|
Age, Customized
Age
|
51 years
n=37 Participants
|
55 years
n=37 Participants
|
58 years
n=74 Participants
|
66 years
n=267 Participants
|
68 years
n=272 Participants
|
42 years
n=6 Participants
|
44 years
n=36 Participants
|
61 years
n=18 Participants
|
55.5 years
n=1946 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
3 Participants
n=74 Participants
|
1 Participants
n=267 Participants
|
3 Participants
n=272 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=18 Participants
|
17 Participants
n=1946 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=37 Participants
|
3 Participants
n=37 Participants
|
6 Participants
n=74 Participants
|
3 Participants
n=267 Participants
|
4 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=18 Participants
|
21 Participants
n=1946 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=1946 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=1946 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=1946 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=37 Participants
|
2 Participants
n=37 Participants
|
5 Participants
n=74 Participants
|
3 Participants
n=267 Participants
|
5 Participants
n=272 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=18 Participants
|
25 Participants
n=1946 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=1946 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
3 Participants
n=74 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=18 Participants
|
8 Participants
n=1946 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=1946 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=37 Participants
|
3 Participants
n=37 Participants
|
4 Participants
n=74 Participants
|
1 Participants
n=267 Participants
|
6 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=36 Participants
|
6 Participants
n=18 Participants
|
24 Participants
n=1946 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
3 Participants
n=74 Participants
|
2 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=18 Participants
|
6 Participants
n=1946 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
2 Participants
n=74 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=272 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=18 Participants
|
6 Participants
n=1946 Participants
|
PRIMARY outcome
Timeframe: Start of treatment to 30 days post last dose. up to 1.5 yearsIncidence of grade 3 and above Treatment Related Emergent Adverse Events (TRAEs)
Outcome measures
| Measure |
40 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=2 Participants
40 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
120 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=3 Participants
120 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
180 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=9 Participants
180 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
240 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=4 Participants
240 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
60 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
n=7 Participants
60 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
80 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
n=3 Participants
80 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
80 mg BID RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
n=4 Participants
80 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
120 mg QD RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
n=6 Participants
120 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of RP 6306 in Combination With FOLFIRI
|
1 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: During 28 days (2 cycles) from the initiation of the study treatmentPopulation: DLT evaluable
Evaluation of dose-limiting toxicities (DLTs) at or below a frequency of 25%.
Outcome measures
| Measure |
40 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=2 Participants
40 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
120 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=3 Participants
120 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
180 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=5 Participants
180 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
240 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=3 Participants
240 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
60 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
n=5 Participants
60 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
80 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
n=2 Participants
80 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
80 mg BID RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
n=2 Participants
80 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
120 mg QD RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
n=4 Participants
120 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
|---|---|---|---|---|---|---|---|---|
|
Recommended Phase 2 Dose (RP2D) and Schedule of RP-6306 in Combination With FOLFIRI
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
40 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
120 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
180 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
Serious events: 5 serious events
Other events: 9 other events
Deaths: 3 deaths
240 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
60 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
Serious events: 3 serious events
Other events: 7 other events
Deaths: 2 deaths
80 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
80 mg BID RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
120 mg QD RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
Serious events: 2 serious events
Other events: 6 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
40 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=2 participants at risk
40 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
120 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=3 participants at risk
120 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
180 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=9 participants at risk
180 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
240 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=4 participants at risk
240 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
60 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
n=7 participants at risk
60 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
80 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
n=3 participants at risk
80 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
80 mg BID RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
n=4 participants at risk
80 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
120 mg QD RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
n=6 participants at risk
120 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Infections and infestations
Biliary infection
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Infections and infestations
Clostridium Difficile infection
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Infections and infestations
Pyelonephritis
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Small Intestinal obstruction
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
General disorders
Mucosal inflammation
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Investigations
Blood bilirubin
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Metabolism and nutrition disorders
Hypophosphatamia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Renal and urinary disorders
Acute Kidney injury
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
Other adverse events
| Measure |
40 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=2 participants at risk
40 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
120 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=3 participants at risk
120 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
180 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=9 participants at risk
180 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
240 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI
n=4 participants at risk
240 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
60 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
n=7 participants at risk
60 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
80 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI
n=3 participants at risk
80 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
80 mg BID RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
n=4 participants at risk
80 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
120 mg QD RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI
n=6 participants at risk
120 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
66.7%
2/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
3/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
22.2%
2/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
3/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Ear and labyrinth disorders
Dry Eye
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
71.4%
5/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
66.7%
2/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
66.7%
4/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
66.7%
2/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
3/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
42.9%
3/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
66.7%
4/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Vomitting
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
22.2%
2/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
42.9%
3/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
44.4%
4/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
75.0%
3/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
3/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
General disorders
Fatigue
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
44.4%
4/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
71.4%
5/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
3/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
General disorders
Mucosal inflammation
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
66.7%
2/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
22.2%
2/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
66.7%
2/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
3/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
General disorders
Pyrexia
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
44.4%
4/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
General disorders
Chills
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
22.2%
2/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Infections and infestations
Candida infection
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Infections and infestations
Pneumonia
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Investigations
Weight decreased
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Investigations
SAR-COV-2 test positive
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
22.2%
2/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
42.9%
3/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Metabolism and nutrition disorders
Hyponatramia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
22.2%
2/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
2/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Nervous system disorders
Taste Disorder
|
100.0%
2/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
66.7%
2/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Nervous system disorders
dizziness
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Nervous system disorders
dysgeusia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Nervous system disorders
memory impairment
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Nervous system disorders
presyncope
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Psychiatric disorders
insomnia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Renal and urinary disorders
haematuria
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Renal and urinary disorders
pollakiuria
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Renal and urinary disorders
proteinuria
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorder
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
100.0%
2/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
50.0%
1/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea exertional
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
66.7%
2/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
alopecia
|
100.0%
2/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
22.2%
2/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
3/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
rash
|
100.0%
2/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
11.1%
1/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
palmar-plantar Erythrodysaesthesia
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
22.2%
2/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
25.0%
1/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Skin and subcutaneous tissue disorders
skin discoloration
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
28.6%
2/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
16.7%
1/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Vascular disorders
flushing
|
0.00%
0/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
14.3%
1/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
2/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
2/2 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
1/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
33.3%
3/9 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/7 • Start of treatment to 30 days post last dose. up to 1.5 years
|
0.00%
0/3 • Start of treatment to 30 days post last dose. up to 1.5 years
|
50.0%
2/4 • Start of treatment to 30 days post last dose. up to 1.5 years
|
66.7%
4/6 • Start of treatment to 30 days post last dose. up to 1.5 years
|
Additional Information
Repare Therapeutics Medical Monitor
Repare Therapeutics INC
Phone: 857-340-5402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place