Trial Outcomes & Findings for Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors (NCT NCT06560632)
NCT ID: NCT06560632
Last Updated: 2026-01-16
Results Overview
The assessment of DLTs was conducted to evaluate the safety and tolerability of RP-3467 administered as monotherapy and in combination with olaparib in participants with advanced solid tumors.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Start of treatment to 30 days post last dose, up to 13 months
Results posted on
2026-01-16
Participant Flow
Participant milestones
| Measure |
Arm 1: 160 mg QD RP-3467
160 mg RP-3467 taken QD (once a day) orally in 3 weeks (21 day cycle)
|
Arm 1: 320 mg QD RP-3467
320 mg RP-3467 taken QD (once a day) orally in 3 weeks (21 day cycle)
|
Arm 1: 640 mg QD RP-3467
640 mg RP-3467 taken QD (once a day) orally in 3 weeks (21 day cycle)
|
Arm 2: 80 mg QD RP-3467 + 200 mg BID Olaparib
80 mg RP-3467 taken QD orally in combination with 200 mg BID (twice daily) olaparib taken orally for 3 weeks (21 day cycle)
|
Arm 2: 80 mg QD RP-3467 + 300 mg BID Olaparib
80 mg RP-3467 taken QD orally in combination with 300 mg BID (twice daily) olaparib taken orally for 3 weeks (21 day cycle)
|
Arm 2: 40 mg QD RP-3467 + 300 mg BID Olaparib
40 mg RP-3467 taken QD orally in combination with 300 mg BID (twice daily) olaparib taken orally for 3 weeks (21 day cycle)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
4
|
3
|
2
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
4
|
3
|
2
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Arm 1: 160 mg QD RP-3467
n=1 Participants
160 mg RP-3467 taken QD (once a day) orally in 3 weeks (21 day cycle)
|
Arm 1: 320 mg QD RP-3467
n=3 Participants
320 mg RP-3467 taken QD (once a day) orally in 3 weeks (21 day cycle)
|
Arm 1: 640 mg QD RP-3467
n=4 Participants
640 mg RP-3467 taken QD (once a day) orally in 3 weeks (21 day cycle)
|
Arm 2: 80 mg QD RP-3467 + 200 mg BID Olaparib
n=3 Participants
80 mg RP-3467 taken QD orally in combination with 200 mg BID (twice daily) olaparib taken orally for 3 weeks (21 day cycle)
|
Arm 2: 80 mg QD RP-3467 + 300 mg BID Olaparib
n=2 Participants
80 mg RP-3467 taken QD orally in combination with 300 mg BID (twice daily) olaparib taken orally for 3 weeks (21 day cycle)
|
Arm 2: 40 mg QD RP-3467 + 300 mg BID Olaparib
n=13 Participants
40 mg RP-3467 taken QD orally in combination with 300 mg BID (twice daily) olaparib taken orally for 3 weeks (21 day cycle)
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 0 • n=9 Participants
|
55.7 years
STANDARD_DEVIATION 5.51 • n=6 Participants
|
54.0 years
STANDARD_DEVIATION 13.74 • n=9 Participants
|
75.0 years
STANDARD_DEVIATION 6.24 • n=17 Participants
|
52.5 years
STANDARD_DEVIATION 2.12 • n=16 Participants
|
55.5 years
STANDARD_DEVIATION 12.78 • n=82 Participants
|
57.7 years
STANDARD_DEVIATION 12.36 • n=13 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=16 Participants
|
12 Participants
n=82 Participants
|
22 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=82 Participants
|
4 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=82 Participants
|
3 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
2 Participants
n=17 Participants
|
2 Participants
n=16 Participants
|
10 Participants
n=82 Participants
|
21 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=82 Participants
|
2 Participants
n=13 Participants
|
|
Any Prior PARP inhibitor therapy
Yes
|
1 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
2 Participants
n=17 Participants
|
2 Participants
n=16 Participants
|
12 Participants
n=82 Participants
|
24 Participants
n=13 Participants
|
|
Any Prior PARP inhibitor therapy
No
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=82 Participants
|
2 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: Start of treatment to 30 days post last dose, up to 13 monthsThe assessment of DLTs was conducted to evaluate the safety and tolerability of RP-3467 administered as monotherapy and in combination with olaparib in participants with advanced solid tumors.
Outcome measures
| Measure |
Arm 1: 160 mg QD RP-3467
n=1 Participants
160 mg RP-3467 taken QD (once a day) orally in 3 weeks (21 day cycle)
|
Arm 1: 320 mg QD RP-3467
n=3 Participants
320 mg RP-3467 taken QD (once a day) orally in 3 weeks (21 day cycle)
|
Arm 1: 640 mg QD RP-3467
n=3 Participants
640 mg RP-3467 taken QD (once a day) orally in 3 weeks (21 day cycle)
|
Arm 2: 80 mg QD RP-3467 + 200 mg BID Olaparib
n=3 Participants
80 mg RP-3467 taken QD orally in combination with 200 mg BID (twice daily) olaparib taken orally for 3 weeks (21 day cycle)
|
Arm 2: 80 mg QD RP-3467 + 300 mg BID Olaparib
n=1 Participants
80 mg RP-3467 taken QD orally in combination with 300 mg BID (twice daily) olaparib taken orally for 3 weeks (21 day cycle)
|
Arm 2: 40 mg QD RP-3467 + 300 mg BID Olaparib
n=13 Participants
40 mg RP-3467 taken QD orally in combination with 300 mg BID (twice daily) olaparib taken orally for 3 weeks (21 day cycle)
|
|---|---|---|---|---|---|---|
|
The Number of Participants Who Experienced Dose-limiting Toxicities (DLT) During the Study Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Arm 2: 40 mg RP-3467 QD+300 mg BID Ola
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm 1: 640 mg RP-3467 QD
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm 2: 80 mg RP-3467 QD+200 mg BID Ola
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2: 80 mg RP-3467 QD+300 mg BID Ola
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Arm 1: 160 mg RP-3467 QD
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 1: 320 mg RP-3467 QD
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 2: 40 mg RP-3467 QD+300 mg BID Ola
n=13 participants at risk
Arm 2: 40 mg RP-3467 taken QD orally in combination with 300 mg BID (twice daily) olaparib taken orally for 3 weeks (21 day cycle)
|
Arm 1: 640 mg RP-3467 QD
n=4 participants at risk
Arm 1: 640 mg RP-3467 taken QD (once a day) orally in 3 weeks (21 day cycle)
|
Arm 2: 80 mg RP-3467 QD+200 mg BID Ola
n=3 participants at risk
Arm 2: 80 mg RP-3467 taken QD orally in combination with 200 mg BID (twice daily) olaparib taken orally for 3 weeks (21 day cycle)
|
Arm 2: 80 mg RP-3467 QD+300 mg BID Ola
n=2 participants at risk
Arm 2: 80 mg RP-3467 taken QD orally in combination with 300 mg BID (twice daily) olaparib taken orally for 3 weeks (21 day cycle)
|
Arm 1: 160 mg RP-3467 QD
n=1 participants at risk
Arm 1: 160 mg RP-3467 taken QD (once a day) orally in 3 weeks (21 day cycle)
|
Arm 1: 320 mg RP-3467 QD
n=3 participants at risk
Arm 1: 320 mg RP-3467 taken QD (once a day) orally in 3 weeks (21 day cycle)
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
25.0%
1/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
25.0%
1/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
25.0%
1/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Cardiac disorders
Pericardial effusion
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
100.0%
1/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
33.3%
1/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
33.3%
1/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
50.0%
1/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
Other adverse events
| Measure |
Arm 2: 40 mg RP-3467 QD+300 mg BID Ola
n=13 participants at risk
Arm 2: 40 mg RP-3467 taken QD orally in combination with 300 mg BID (twice daily) olaparib taken orally for 3 weeks (21 day cycle)
|
Arm 1: 640 mg RP-3467 QD
n=4 participants at risk
Arm 1: 640 mg RP-3467 taken QD (once a day) orally in 3 weeks (21 day cycle)
|
Arm 2: 80 mg RP-3467 QD+200 mg BID Ola
n=3 participants at risk
Arm 2: 80 mg RP-3467 taken QD orally in combination with 200 mg BID (twice daily) olaparib taken orally for 3 weeks (21 day cycle)
|
Arm 2: 80 mg RP-3467 QD+300 mg BID Ola
n=2 participants at risk
Arm 2: 80 mg RP-3467 taken QD orally in combination with 300 mg BID (twice daily) olaparib taken orally for 3 weeks (21 day cycle)
|
Arm 1: 160 mg RP-3467 QD
n=1 participants at risk
Arm 1: 160 mg RP-3467 taken QD (once a day) orally in 3 weeks (21 day cycle)
|
Arm 1: 320 mg RP-3467 QD
n=3 participants at risk
Arm 1: 320 mg RP-3467 taken QD (once a day) orally in 3 weeks (21 day cycle)
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
25.0%
1/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
25.0%
1/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Gastrointestinal disorders
Nausea
|
23.1%
3/13 • Start of treatment to 30 days post last dose, up to 13 months
|
25.0%
1/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
33.3%
1/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
50.0%
2/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
General disorders and administration site conditions
Fatigue
|
23.1%
3/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
33.3%
1/3 • Start of treatment to 30 days post last dose, up to 13 months
|
50.0%
1/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
33.3%
1/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
General disorders and administration site conditions
Oedema peripheral
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Infections and infestations
COVID-19
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
33.3%
1/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
25.0%
1/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
100.0%
1/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Investigations
Blood creatinine increased
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Investigations
Weight decreased
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
33.3%
1/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
25.0%
1/4 • Start of treatment to 30 days post last dose, up to 13 months
|
66.7%
2/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
33.3%
1/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
33.3%
1/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
25.0%
1/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
33.3%
1/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
33.3%
1/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Nervous system disorders
Restless legs syndrome
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
25.0%
1/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Renal and urinary disorders
Dysuria
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
100.0%
1/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
33.3%
1/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
100.0%
1/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
25.0%
1/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Blood and lymphatic system disorders
Anaemia
|
38.5%
5/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
66.7%
2/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
100.0%
1/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
33.3%
1/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
33.3%
1/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Eye disorders
Asthenopia
|
7.7%
1/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/4 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/2 • Start of treatment to 30 days post last dose, up to 13 months
|
100.0%
1/1 • Start of treatment to 30 days post last dose, up to 13 months
|
0.00%
0/3 • Start of treatment to 30 days post last dose, up to 13 months
|
Additional Information
Repare Therapeutics Medical Monitor
Repare Therapeutics Inc
Phone: 1 (857) 340-5402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In this multi center study, authors are required to abide by the restriction that the first publication is to include data from all investigational sites.
- Publication restrictions are in place
Restriction type: OTHER