Trial Outcomes & Findings for Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma (NCT NCT02567656)
NCT ID: NCT02567656
Last Updated: 2020-01-13
Results Overview
Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
58 participants
Primary outcome timeframe
28 days
Results posted on
2020-01-13
Participant Flow
Participant milestones
| Measure |
Dose escalation_Cohort 1_200 mg
RP6530 administered 200 mg orally twice a day.
|
Dose escalation_Cohort 2_400 mg
RP6530 administered 400 mg orally twice a day.
|
Dose escalation_Cohort 3_800 mg (Fasting)
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose escalation_Cohort 4_800 mg (Fed)
RP6530 administered 800 mg orally twice a day under fed condition
|
Dose expansion_PTCL_800 mg (Fasting)
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose expansion_CTCL_800 mg (Fasting)
RP6530 administered 800 mg orally twice a day under fasting condition
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
5
|
6
|
19
|
20
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
6
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dose escalation_Cohort 1_200 mg
RP6530 administered 200 mg orally twice a day.
|
Dose escalation_Cohort 2_400 mg
RP6530 administered 400 mg orally twice a day.
|
Dose escalation_Cohort 3_800 mg (Fasting)
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose escalation_Cohort 4_800 mg (Fed)
RP6530 administered 800 mg orally twice a day under fed condition
|
Dose expansion_PTCL_800 mg (Fasting)
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose expansion_CTCL_800 mg (Fasting)
RP6530 administered 800 mg orally twice a day under fasting condition
|
|---|---|---|---|---|---|---|
|
Overall Study
Premature discontinuation due to PD
|
1
|
1
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma
Baseline characteristics by cohort
| Measure |
Dose escalation_Cohort 1_200 mg
n=4 Participants
RP6530 administered 200 mg orally twice a day.
|
Dose escalation_Cohort 2_400 mg
n=4 Participants
RP6530 administered 400 mg orally twice a day.
|
Dose escalation_Cohort 3_800 mg (Fasting)
n=5 Participants
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose escalation_Cohort 4_800 mg (Fed)
n=6 Participants
RP6530 administered 800 mg orally twice a day under fed condition
|
Dose expansion_PTCL_800 mg (Fasting)
n=19 Participants
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose expansion_CTCL_800 mg (Fasting)
n=20 Participants
RP6530 administered 800 mg orally twice a day under fasting condition
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.45 Years
n=5 Participants
|
65.03 Years
n=7 Participants
|
67.89 Years
n=5 Participants
|
65.86 Years
n=4 Participants
|
63.95 Years
n=21 Participants
|
67.07 Years
n=8 Participants
|
67.07 Years
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
30 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
49 Participants
n=8 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=8 Participants
|
0 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
19 participants
n=21 Participants
|
20 participants
n=8 Participants
|
58 participants
n=8 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) treatment with Tenalisib and is considered related to Tenalisib.
Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0
Outcome measures
| Measure |
Dose escalation_Cohort 1_200 mg
n=4 Participants
RP6530 administered 200 mg orally twice a day.
|
Dose escalation_Cohort 2_400 mg
n=4 Participants
RP6530 administered 400 mg orally twice a day.
|
Dose escalation_Cohort 3_800 mg (Fasting)
n=5 Participants
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose escalation_Cohort 4_800 mg (Fed)
n=6 Participants
RP6530 administered 800 mg orally twice a day under fed condition
|
Dose expansion_PTCL_800 mg (Fasting)
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose expansion_CTCL_800 mg (Fasting)
RP6530 administered 800 mg orally twice a day under fasting condition
|
|---|---|---|---|---|---|---|
|
Safety of RP6530
No.of Participants with Dose Limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety of RP6530
No.of Participants without Dose Limiting Toxicitie
|
4 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 monthsPopulation: Patients were considered for efficacy analysis as per protocol only if they had one post treatment efficacy assessment at C3D1
ORR is defined as sum of CR and PR rates, Response assessment for PTCL based on IWG criteria (Cheson 2007) and CTCL on mSWAT/Global assessment (ISCL/EORTC guideline).
Outcome measures
| Measure |
Dose escalation_Cohort 1_200 mg
n=3 Participants
RP6530 administered 200 mg orally twice a day.
|
Dose escalation_Cohort 2_400 mg
n=2 Participants
RP6530 administered 400 mg orally twice a day.
|
Dose escalation_Cohort 3_800 mg (Fasting)
n=3 Participants
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose escalation_Cohort 4_800 mg (Fed)
n=5 Participants
RP6530 administered 800 mg orally twice a day under fed condition
|
Dose expansion_PTCL_800 mg (Fasting)
n=10 Participants
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose expansion_CTCL_800 mg (Fasting)
n=12 Participants
RP6530 administered 800 mg orally twice a day under fasting condition
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) With RP6530
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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_200 mg
n=1 Participants
RP6530 administered 200 mg orally twice a day.
|
Dose escalation_Cohort 2_400 mg
n=2 Participants
RP6530 administered 400 mg orally twice a day.
|
Dose escalation_Cohort 3_800 mg (Fasting)
n=2 Participants
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose escalation_Cohort 4_800 mg (Fed)
n=2 Participants
RP6530 administered 800 mg orally twice a day under fed condition
|
Dose expansion_PTCL_800 mg (Fasting)
n=4 Participants
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose expansion_CTCL_800 mg (Fasting)
n=5 Participants
RP6530 administered 800 mg orally twice a day under fasting condition
|
|---|---|---|---|---|---|---|
|
Duration of Response (DOR) With RP6530
|
147 Days
Interval 147.0 to 147.0
|
72 Days
Interval 29.0 to 115.0
|
313 Days
Interval 68.0 to 557.0
|
99 Days
Interval 50.0 to 148.0
|
141 Days
Interval 56.0 to 391.0
|
307 Days
Interval 67.0 to 588.0
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1Population: Peak Plasma Concentration (Cmax) of RP6530 at Cycle 1 day 1
Peak Plasma Concentration (Cmax) of RP6530
Outcome measures
| Measure |
Dose escalation_Cohort 1_200 mg
n=4 Participants
RP6530 administered 200 mg orally twice a day.
|
Dose escalation_Cohort 2_400 mg
n=4 Participants
RP6530 administered 400 mg orally twice a day.
|
Dose escalation_Cohort 3_800 mg (Fasting)
n=5 Participants
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose escalation_Cohort 4_800 mg (Fed)
n=6 Participants
RP6530 administered 800 mg orally twice a day under fed condition
|
Dose expansion_PTCL_800 mg (Fasting)
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose expansion_CTCL_800 mg (Fasting)
RP6530 administered 800 mg orally twice a day under fasting condition
|
|---|---|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax)
|
1297.65 ng/mL
Standard Deviation 622.81
|
2196.65 ng/mL
Standard Deviation 676.45
|
3995.68 ng/mL
Standard Deviation 1392.74
|
2668.05 ng/mL
Standard Deviation 1713.17
|
—
|
—
|
Adverse Events
Dose escalation_Cohort 1_200 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose escalation_Cohort 2_400 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose escalation_Cohort 3_800 mg (Fasting)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths
Dose escalation_Cohort 4_800 mg (Fed)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths
Dose expansion_PTCL_800 mg (Fasting)
Serious events: 3 serious events
Other events: 11 other events
Deaths: 3 deaths
Dose expansion_CTCL_800 mg (Fasting)
Serious events: 3 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose escalation_Cohort 1_200 mg
n=4 participants at risk
RP6530 administered 200 mg orally twice a day.
|
Dose escalation_Cohort 2_400 mg
n=4 participants at risk
RP6530 administered 400 mg orally twice a day.
|
Dose escalation_Cohort 3_800 mg (Fasting)
n=5 participants at risk
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose escalation_Cohort 4_800 mg (Fed)
n=6 participants at risk
RP6530 administered 800 mg orally twice a day under fed condition
|
Dose expansion_PTCL_800 mg (Fasting)
n=19 participants at risk
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose expansion_CTCL_800 mg (Fasting)
n=20 participants at risk
RP6530 administered 800 mg orally twice a day under fasting condition
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Pyrexia
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/6 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
5.3%
1/19 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/20 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/6 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
5.3%
1/19 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/20 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Investigations
International normalized ratio increased
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/6 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
5.3%
1/19 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/20 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Eye disorders
Diplopia
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/6 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/19 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
5.0%
1/20 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/6 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/19 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
5.0%
1/20 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Infections and infestations
Skin Infection
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/6 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/19 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
5.0%
1/20 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
Other adverse events
| Measure |
Dose escalation_Cohort 1_200 mg
n=4 participants at risk
RP6530 administered 200 mg orally twice a day.
|
Dose escalation_Cohort 2_400 mg
n=4 participants at risk
RP6530 administered 400 mg orally twice a day.
|
Dose escalation_Cohort 3_800 mg (Fasting)
n=5 participants at risk
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose escalation_Cohort 4_800 mg (Fed)
n=6 participants at risk
RP6530 administered 800 mg orally twice a day under fed condition
|
Dose expansion_PTCL_800 mg (Fasting)
n=19 participants at risk
RP6530 administered 800 mg orally twice a day under fasting condition
|
Dose expansion_CTCL_800 mg (Fasting)
n=20 participants at risk
RP6530 administered 800 mg orally twice a day under fasting condition
|
|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
40.0%
2/5 • Number of events 3 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
50.0%
3/6 • Number of events 3 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
21.1%
4/19 • Number of events 5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
40.0%
8/20 • Number of events 13 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 3 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
40.0%
2/5 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
50.0%
3/6 • Number of events 10 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
21.1%
4/19 • Number of events 5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
40.0%
8/20 • Number of events 15 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
20.0%
1/5 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
16.7%
1/6 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
10.5%
2/19 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
35.0%
7/20 • Number of events 8 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
General disorders
Fatigue
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
25.0%
1/4 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
16.7%
1/6 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
5.3%
1/19 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
30.0%
6/20 • Number of events 6 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
33.3%
2/6 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/19 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
25.0%
5/20 • Number of events 7 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
16.7%
1/6 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
5.3%
1/19 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
10.0%
2/20 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
20.0%
1/5 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
16.7%
1/6 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/19 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
15.0%
3/20 • Number of events 3 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
20.0%
1/5 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
16.7%
1/6 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/19 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
15.0%
3/20 • Number of events 3 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
20.0%
1/5 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
16.7%
1/6 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/19 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
10.0%
2/20 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
25.0%
1/4 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/6 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
5.3%
1/19 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
10.0%
2/20 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
25.0%
1/4 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/6 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/19 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
15.0%
3/20 • Number of events 3 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
33.3%
2/6 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/19 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
10.0%
2/20 • Number of events 3 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
16.7%
1/6 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
5.3%
1/19 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
5.0%
1/20 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
33.3%
2/6 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/19 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
5.0%
1/20 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
20.0%
1/5 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/6 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/19 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
10.0%
2/20 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
16.7%
1/6 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/19 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
10.0%
2/20 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
25.0%
1/4 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/6 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/19 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
5.0%
1/20 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
General disorders
Pyrexia
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/6 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
5.3%
1/19 • Number of events 3 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
10.0%
2/20 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
16.7%
1/6 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/19 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
10.0%
2/20 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/4 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/5 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
16.7%
1/6 • Number of events 1 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
0.00%
0/19 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
10.0%
2/20 • Number of events 2 • 24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place