Trial Outcomes & Findings for Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma (NCT NCT03770000)
NCT ID: NCT03770000
Last Updated: 2022-10-28
Results Overview
The DLTs will be classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
28 days
Results posted on
2022-10-28
Participant Flow
Participant milestones
| Measure |
Dose escalation_Cohort 2
RP6530 was administered at 600 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 3
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 1
RP6530 was administered at 400 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 1 (PTCL)
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 2 (CTCL)
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
12
|
12
|
|
Overall Study
COMPLETED
|
3
|
2
|
3
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
3
|
2
|
Reasons for withdrawal
| Measure |
Dose escalation_Cohort 2
RP6530 was administered at 600 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 3
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 1
RP6530 was administered at 400 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 1 (PTCL)
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 2 (CTCL)
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
|---|---|---|---|---|---|
|
Overall Study
Premature discontinuation due to PD
|
0
|
1
|
0
|
3
|
2
|
Baseline Characteristics
Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma
Baseline characteristics by cohort
| Measure |
Dose escalation_Cohort 1
n=3 Participants
RP6530 was administered at 400 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 2
n=3 Participants
RP6530 was administered at 600 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 3
n=3 Participants
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 1 (PTCL)
n=12 Participants
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 2 (CTCL)
n=12 Participants
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.79 years
n=5 Participants
|
55.72 years
n=7 Participants
|
49.03 years
n=5 Participants
|
67.62 years
n=4 Participants
|
69.67 years
n=21 Participants
|
66.21 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
12 participants
n=4 Participants
|
12 participants
n=21 Participants
|
33 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: DLT assessment performed in patients who participated in dose escalation phase; A toxicity will be considered dose-limiting if it occurs during the first cycle (4-weeks) of treatment with Tenalisib and Romidepsin combination and is considered related to combination.
The DLTs will be classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Outcome measures
| Measure |
Dose escalation_Cohort 1
n=3 Participants
RP6530 was administered at 400 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 2
n=3 Participants
RP6530 was administered at 600 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 3
n=3 Participants
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 1 (PTCL)
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 2 (CTCL)
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
|---|---|---|---|---|---|
|
Number of Participants With and Without Dose Limiting Toxicities (DLTs)
No.of Participants with Dose Limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With and Without Dose Limiting Toxicities (DLTs)
No.of Participants without Dose Limiting Toxicities
|
3 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Patients were considered for efficacy analysis as per protocol only if they had one post treatment efficacy assessment at C3D1
Overall response (ORR) = CR + PR) was assessed according to the Lugano classification with PTCL and according to the modified Severity Weighted Assessment Tool (mSWAT)/Global assessment in patients with CTCL.
Outcome measures
| Measure |
Dose escalation_Cohort 1
n=3 Participants
RP6530 was administered at 400 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 2
n=3 Participants
RP6530 was administered at 600 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 3
n=2 Participants
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 1 (PTCL)
n=9 Participants
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 2 (CTCL)
n=10 Participants
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
|---|---|---|---|---|---|
|
Overall Response Rate (ORR) With Tenalisib and Romidepsin Combination
|
2 Participants
|
2 Participants
|
0 Participants
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 28 weeksPopulation: Duration of Response (DoR) is defined as the time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death. Overall number of Participants analyzed for DoR will be the participants who met response as CR or PR
The time period from the response achieved in patient until the disease progression
Outcome measures
| Measure |
Dose escalation_Cohort 1
n=2 Participants
RP6530 was administered at 400 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 2
n=2 Participants
RP6530 was administered at 600 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 3
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 1 (PTCL)
n=7 Participants
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 2 (CTCL)
n=6 Participants
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
|---|---|---|---|---|---|
|
Duration of Response (DoR) With Tenalisib and Romidepsin Combination
|
151 days
Interval 65.0 to 151.0
|
151 days
Interval 65.0 to 151.0
|
—
|
151 days
Interval 65.0 to 151.0
|
114 days
Interval 57.0 to 114.0
|
SECONDARY outcome
Timeframe: 8 daysPopulation: Peak Plasma Concentration (Cmax) of RP6530 at Cycle 1 day 8.
Assessment of Cmax in subjects treated with Tenalisib and Romidepsin combination. Blood samples for measurement of RP6530 plasma concentrations were collected pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 11 hours after dosing on Day 8 of the first cycle. Maximum (peak) drug concentration (Cmax in nanograms/milliliter) was estimated using Single-Dose data.
Outcome measures
| Measure |
Dose escalation_Cohort 1
n=3 Participants
RP6530 was administered at 400 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 2
n=3 Participants
RP6530 was administered at 600 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 3
n=3 Participants
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 1 (PTCL)
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 2 (CTCL)
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
1544.42 nanogram/millilitre
Standard Deviation 1609.44
|
2152.17 nanogram/millilitre
Standard Deviation 748.83
|
5791.11 nanogram/millilitre
Standard Deviation 2426.44
|
—
|
—
|
Adverse Events
Dose escalation_Cohort 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose escalation_Cohort 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose escalation_Cohort 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose expansion_Group 1 (PTCL)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 1 deaths
Dose expansion_Group 2 (CTCL)
Serious events: 2 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose escalation_Cohort 1
n=3 participants at risk
RP6530 was administered at 400 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 2
n=3 participants at risk
RP6530 was administered at 600 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 3
n=3 participants at risk
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 1 (PTCL)
n=12 participants at risk
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 2 (CTCL)
n=12 participants at risk
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
Other adverse events
| Measure |
Dose escalation_Cohort 1
n=3 participants at risk
RP6530 was administered at 400 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 2
n=3 participants at risk
RP6530 was administered at 600 mg BID orally daily and Romidepsin was administered at 12 mg/m2, IV on day 1, 8 and 15
|
Dose escalation_Cohort 3
n=3 participants at risk
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 1 (PTCL)
n=12 participants at risk
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
Dose expansion_Group 2 (CTCL)
n=12 participants at risk
RP6530 was administered at 800 mg BID orally daily and Romidepsin was administered at 14 mg/m2, IV on day 1, 8 and 15
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
3/3 • Number of events 5 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
66.7%
2/3 • Number of events 6 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
66.7%
2/3 • Number of events 7 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
66.7%
8/12 • Number of events 33 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
4/12 • Number of events 11 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 5 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
41.7%
5/12 • Number of events 24 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 18 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 4 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
4/12 • Number of events 4 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
66.7%
8/12 • Number of events 10 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
100.0%
12/12 • Number of events 20 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
50.0%
6/12 • Number of events 7 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
25.0%
3/12 • Number of events 5 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Gastrointestinal disorders
Abdomial pain upper
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 4 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
50.0%
6/12 • Number of events 6 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
58.3%
7/12 • Number of events 9 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
General disorders
Chills
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
25.0%
3/12 • Number of events 5 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
58.3%
7/12 • Number of events 21 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 7 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
50.0%
6/12 • Number of events 19 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
25.0%
3/12 • Number of events 4 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 6 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 7 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 4 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 4 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Investigations
Blood Creatinine increased
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
25.0%
3/12 • Number of events 3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
25.0%
3/12 • Number of events 7 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
25.0%
3/12 • Number of events 3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 5 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Nervous system disorders
Tremor
|
33.3%
1/3 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 1 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
8.3%
1/12 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/3 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
16.7%
2/12 • Number of events 2 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
0.00%
0/12 • 7 months
Summary of Related Treatment-Emergent Adverse Events - All Patients. Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. The related adverse events (irrespective of single-agent or combination related) are reported here.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place