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Trial Outcomes & Findings for A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas (NCT NCT00878800)

NCT ID: NCT00878800

Last Updated: 2015-07-28

Results Overview

Maximum Tolerated Dose (MTD) of PXD101treatment

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

41 participants

Primary outcome timeframe

During Cohort 1 to 4, Cycle 1 only, up to 3 weeks

Results posted on

2015-07-28

Participant Flow

Participant milestones

Participant milestones
Measure
Cohort 1: BelDox IV (600/50)
PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
Cohort 2: BelDox IV (600/75)
PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
Cohort 3: BelDox IV (800/75)
PXD101 and doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
Cohort 4: BelDox IV (1000/75)
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
MTD Expansion: BelDox IV (1000/75)
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Overall Study
STARTED
3
7
9
6
16
Overall Study
COMPLETED
0
0
0
0
0
Overall Study
NOT COMPLETED
3
7
9
6
16

Reasons for withdrawal

Reasons for withdrawal
Measure
Cohort 1: BelDox IV (600/50)
PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
Cohort 2: BelDox IV (600/75)
PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
Cohort 3: BelDox IV (800/75)
PXD101 and doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
Cohort 4: BelDox IV (1000/75)
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
MTD Expansion: BelDox IV (1000/75)
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Overall Study
Adverse Event
0
0
2
0
1
Overall Study
Progressive disease
1
5
6
5
13
Overall Study
Withdrew consent
1
1
0
1
1
Overall Study
Death
0
0
1
0
0
Overall Study
Other
1
1
0
0
1

Baseline Characteristics

A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort 1: BelDox IV (600/50)
n=3 Participants
PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
Cohort 2: BelDox IV (600/75)
n=7 Participants
PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
Cohort 3: BelDox IV (800/75)
n=9 Participants
PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
Cohort 4: BelDox IV (1000/75)
n=6 Participants
PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
MTD Expansion: BelDox IV (1000/75)
n=16 Participants
PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Total
n=41 Participants
Total of all reporting groups
Age, Categorical
<=18 years
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
Age, Categorical
Between 18 and 65 years
3 Participants
n=5 Participants
5 Participants
n=7 Participants
8 Participants
n=5 Participants
4 Participants
n=4 Participants
11 Participants
n=21 Participants
31 Participants
n=10 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
2 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
5 Participants
n=21 Participants
10 Participants
n=10 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
4 Participants
n=7 Participants
4 Participants
n=5 Participants
0 Participants
n=4 Participants
7 Participants
n=21 Participants
15 Participants
n=10 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
6 Participants
n=4 Participants
9 Participants
n=21 Participants
26 Participants
n=10 Participants

PRIMARY outcome

Timeframe: During Cohort 1 to 4, Cycle 1 only, up to 3 weeks

Maximum Tolerated Dose (MTD) of PXD101treatment

Outcome measures

Outcome measures
Measure
Dose Escalation
n=25 Participants
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
MTD Expansion
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Maximum Tolerated Dose (MTD) PXD101
1000 mg/m²
—

PRIMARY outcome

Timeframe: During Cohort 1 to 4, Cycle 1 only, up to 3 weeks

Maximum Tolerated Dose (MTD) of doxorubicin

Outcome measures

Outcome measures
Measure
Dose Escalation
n=25 Participants
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
MTD Expansion
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Maximum Tolerated Dose (MTD) of Doxorubicin
75 mg/m2
—

PRIMARY outcome

Timeframe: Throughout study

Dose Limiting Toxicity (DLT) of PXD101 and doxorubicin combination treatment

Outcome measures

Outcome measures
Measure
Dose Escalation
n=25 Participants
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
MTD Expansion
n=16 Participants
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Dose Limiting Toxicity (DLT)
0 Dose limiting toxicity
0 Dose limiting toxicity

PRIMARY outcome

Timeframe: Throughout study, after every 2 cycles

Population: The full-analysis set (FAS) comprises all patients enrolled in the study and receiving at least one dose of study drug, and for whom at least one tumor assessment was performed post baseline.

Measured by response rate using the RECIST (Response Evaluation Criteria in Solid Tumors) response criteria (response rate: Complete Response (CR) and Partial Response (PR)) following up to 6 cycles of treatment.

Outcome measures

Outcome measures
Measure
Dose Escalation
n=25 Participants
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
MTD Expansion
n=16 Participants
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Objective Response (CR and PR)
8 percentage of participants
12.5 percentage of participants

SECONDARY outcome

Timeframe: Throughout study, after every 2 cycles

Population: Includes all 41 patients in the FAS population. 37 patients were censored due to no response, 23 in the Dose Escalation group and 14 in the MTD Expansion group.

Outcome measures

Outcome measures
Measure
Dose Escalation
n=25 Participants
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
MTD Expansion
n=16 Participants
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Time to Response
NA months
Interval 0.3 to
Median calculation not available due to only 2 responding patients
NA months
Interval 1.2 to
Median calculation not available due to only 2 responding patients

SECONDARY outcome

Timeframe: Throughout study, after every 2 cycles

Population: Includes only patients with response

Outcome measures

Outcome measures
Measure
Dose Escalation
n=2 Participants
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
MTD Expansion
n=2 Participants
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Duration of Response
3.9 Months
Interval 3.1 to 4.8
7.9 Months
Interval 4.4 to 11.3

SECONDARY outcome

Timeframe: Throughout study, after every 2 cycles

Population: Includes only patients with disease progression.

Outcome measures

Outcome measures
Measure
Dose Escalation
n=18 Participants
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
MTD Expansion
n=15 Participants
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Time to Progression
3.7 months
Interval 3.0 to 5.6
6.0 months
Interval 1.6 to 9.7

SECONDARY outcome

Timeframe: Throughout study, after every 2 cycles

Population: The full-analysis set (FAS) comprises all patients enrolled in the study and receiving at least one dose of study drug, and for whom at least one tumor assessment was performed post baseline.

The disease control rate, defined as best overall response of either objective response or stable disease (CR or PR or SD) following up to 6 cycles of treatment with confirmation according to the RECIST criteria

Outcome measures

Outcome measures
Measure
Dose Escalation
n=25 Participants
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
MTD Expansion
n=16 Participants
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Disease Control Rate (CR or PR or SD)
72.0 percentage of participants
68.8 percentage of participants

SECONDARY outcome

Timeframe: Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion

Population: The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.

Measure the AUC of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2

Outcome measures

Outcome measures
Measure
Dose Escalation
n=21 Participants
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
MTD Expansion
n=19 Participants
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Belinostat AUC (Time 0 to Last Measurement)
23100 ng*h/mL
Geometric Coefficient of Variation 35.4
22100 ng*h/mL
Geometric Coefficient of Variation 43.2

SECONDARY outcome

Timeframe: Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion

Population: The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.

Measure the Cmax of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2

Outcome measures

Outcome measures
Measure
Dose Escalation
n=21 Participants
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
MTD Expansion
n=19 Participants
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Belinostat Cmax
41100 ng/mL
Geometric Coefficient of Variation 35.0
37000 ng/mL
Geometric Coefficient of Variation 59.1

SECONDARY outcome

Timeframe: Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion

Population: The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.

Measure the t½ of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2

Outcome measures

Outcome measures
Measure
Dose Escalation
n=18 Participants
PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
MTD Expansion
n=19 Participants
PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Belinostat t½
1.48 hours
Geometric Coefficient of Variation 71.3
2.13 hours
Geometric Coefficient of Variation 119.4

Adverse Events

Cohort 1: BelDox IV (600/50)

Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths

Cohort 2: BelDox IV (600/75)

Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths

Cohort 3: BelDox IV (800/75)

Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths

Cohort 4: BelDox IV (1000/75)

Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths

MTD Expansion: BelDox IV (1000/75)

Serious events: 10 serious events
Other events: 16 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Cohort 1: BelDox IV (600/50)
n=3 participants at risk
PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
Cohort 2: BelDox IV (600/75)
n=7 participants at risk
PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
Cohort 3: BelDox IV (800/75)
n=9 participants at risk
PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
Cohort 4: BelDox IV (1000/75)
n=6 participants at risk
PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
MTD Expansion: BelDox IV (1000/75)
n=16 participants at risk
PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Blood and lymphatic system disorders
Anaemia
33.3%
1/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
General disorders
Thrombosis in device
33.3%
1/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Investigations
Haemoglobin decreased
33.3%
1/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/3
28.6%
2/7
11.1%
1/9
0.00%
0/6
12.5%
2/16
Investigations
Electrocardiogram QT prolonged
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Gastrointestinal disorders
Vomiting
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Infections and infestations
Abdominal absecss
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Infections and infestations
Bacteriaemia
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Infections and infestations
Infection
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
General disorders
Disease progression
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Infections and infestations
Device related infection
0.00%
0/3
0.00%
0/7
11.1%
1/9
16.7%
1/6
0.00%
0/16
Infections and infestations
Neutropenic sepsis
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Immune system disorders
Hypersensitivity
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Infections and infestations
Pneumonia
0.00%
0/3
0.00%
0/7
0.00%
0/9
33.3%
2/6
6.2%
1/16
Blood and lymphatic system disorders
Neutropenia
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
12.5%
2/16
General disorders
Oedema peripheral
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Gastrointestinal disorders
Nausea
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Cardiac disorders
Myocardial infarction
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Cardiac disorders
Myocardial ischaemia
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Nervous system disorders
Spinal cord compression
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Skin and subcutaneous tissue disorders
Skin swelling
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Vascular disorders
Deep vein thrombosis
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
12.5%
2/16
Vascular disorders
Hypertension
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16

Other adverse events

Other adverse events
Measure
Cohort 1: BelDox IV (600/50)
n=3 participants at risk
PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
Cohort 2: BelDox IV (600/75)
n=7 participants at risk
PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
Cohort 3: BelDox IV (800/75)
n=9 participants at risk
PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
Cohort 4: BelDox IV (1000/75)
n=6 participants at risk
PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
MTD Expansion: BelDox IV (1000/75)
n=16 participants at risk
PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
General disorders
Fatigue
100.0%
3/3
100.0%
7/7
77.8%
7/9
100.0%
6/6
100.0%
16/16
General disorders
Mucosal inflammation
0.00%
0/3
42.9%
3/7
22.2%
2/9
50.0%
3/6
75.0%
12/16
General disorders
Injection site reaction
0.00%
0/3
0.00%
0/7
33.3%
3/9
50.0%
3/6
62.5%
10/16
General disorders
Pyrexia
33.3%
1/3
14.3%
1/7
33.3%
3/9
16.7%
1/6
25.0%
4/16
General disorders
Pain
0.00%
0/3
28.6%
2/7
0.00%
0/9
33.3%
2/6
25.0%
4/16
General disorders
Non-cardiac chest pain
0.00%
0/3
0.00%
0/7
22.2%
2/9
0.00%
0/6
18.8%
3/16
General disorders
Oedema peripheral
0.00%
0/3
28.6%
2/7
0.00%
0/9
0.00%
0/6
18.8%
3/16
General disorders
Chills
0.00%
0/3
0.00%
0/7
22.2%
2/9
16.7%
1/6
0.00%
0/16
General disorders
Influenza like illness
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
12.5%
2/16
General disorders
Chest pain
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
12.5%
2/16
General disorders
General physical health deterioration
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
12.5%
2/16
General disorders
Thrombosis in device
33.3%
1/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
General disorders
Axillary pain
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
General disorders
Catheter site pain
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
General disorders
Catheter site swelling
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
General disorders
Chest discomfort
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
General disorders
Disease progression
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
General disorders
Extravasation
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
General disorders
Injection site pain
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Gastrointestinal disorders
Nausea
66.7%
2/3
57.1%
4/7
66.7%
6/9
83.3%
5/6
87.5%
14/16
Gastrointestinal disorders
Vomiting
33.3%
1/3
57.1%
4/7
44.4%
4/9
50.0%
3/6
75.0%
12/16
Gastrointestinal disorders
Constipation
0.00%
0/3
28.6%
2/7
66.7%
6/9
50.0%
3/6
68.8%
11/16
Gastrointestinal disorders
Diarrhoea
0.00%
0/3
42.9%
3/7
33.3%
3/9
33.3%
2/6
43.8%
7/16
Gastrointestinal disorders
Dyspepsia
0.00%
0/3
0.00%
0/7
0.00%
0/9
66.7%
4/6
18.8%
3/16
Gastrointestinal disorders
Dry mouth
0.00%
0/3
14.3%
1/7
11.1%
1/9
16.7%
1/6
18.8%
3/16
Gastrointestinal disorders
Stomatitis
0.00%
0/3
28.6%
2/7
22.2%
2/9
16.7%
1/6
6.2%
1/16
Gastrointestinal disorders
Abdominal pain
0.00%
0/3
14.3%
1/7
0.00%
0/9
16.7%
1/6
6.2%
1/16
Gastrointestinal disorders
Abdominal distention
0.00%
0/3
0.00%
0/7
11.1%
1/9
16.7%
1/6
0.00%
0/16
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
6.2%
1/16
Gastrointestinal disorders
Haemorrhoids
0.00%
0/3
28.6%
2/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Gastrointestinal disorders
Anal inflammation
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
Gastrointestinal disorders
Anal pruritus
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
Gastrointestinal disorders
Defaecation urgency
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
Gastrointestinal disorders
Dysphagia
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Gastrointestinal disorders
Eructation
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Gastrointestinal disorders
Flatulence
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Gastrointestinal disorders
Gastrooesophagal reflux disease
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Gastrointestinal disorders
Palatal disorder
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Gastrointestinal disorders
Rectal tenesmus
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Gastrointestinal disorders
Salivary hypersecretion
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
Skin and subcutaneous tissue disorders
Alopecia
33.3%
1/3
57.1%
4/7
33.3%
3/9
83.3%
5/6
81.2%
13/16
Skin and subcutaneous tissue disorders
Rash
0.00%
0/3
0.00%
0/7
33.3%
3/9
16.7%
1/6
18.8%
3/16
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/3
28.6%
2/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Skin and subcutaneous tissue disorders
Hair colour changes
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Skin and subcutaneous tissue disorders
Intertrigo
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Skin and subcutaneous tissue disorders
Nail disorder
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Skin and subcutaneous tissue disorders
Night sweats
33.3%
1/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Skin and subcutaneous tissue disorders
Rash papular
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Skin and subcutaneous tissue disorders
Skin swelling
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Skin and subcutaneous tissue disorders
Skin ulcer
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Skin and subcutaneous tissue disorders
Vitiligo
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
Blood and lymphatic system disorders
Neutropenia
33.3%
1/3
85.7%
6/7
22.2%
2/9
33.3%
2/6
68.8%
11/16
Blood and lymphatic system disorders
Anaemia
66.7%
2/3
28.6%
2/7
0.00%
0/9
16.7%
1/6
37.5%
6/16
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/3
28.6%
2/7
11.1%
1/9
0.00%
0/6
18.8%
3/16
Blood and lymphatic system disorders
Leukopenia
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/3
28.6%
2/7
33.3%
3/9
50.0%
3/6
87.5%
14/16
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/3
14.3%
1/7
11.1%
1/9
16.7%
1/6
18.8%
3/16
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/3
14.3%
1/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Respiratory, thoracic and mediastinal disorders
Dyspnoea
66.7%
2/3
14.3%
1/7
44.4%
4/9
66.7%
4/6
68.8%
11/16
Respiratory, thoracic and mediastinal disorders
Cough
33.3%
1/3
0.00%
0/7
22.2%
2/9
0.00%
0/6
18.8%
3/16
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
0.00%
0/3
0.00%
0/7
22.2%
2/9
16.7%
1/6
0.00%
0/16
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
6.2%
1/16
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
12.5%
2/16
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Respiratory, thoracic and mediastinal disorders
Yawning
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Investigations
Neutrophil Count
0.00%
0/3
14.3%
1/7
11.1%
1/9
66.7%
4/6
0.00%
0/16
Investigations
Neutrophil Count Decreased
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
18.8%
3/16
Investigations
Blood Bilirubin
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
6.2%
1/16
Investigations
Blood Potassium Decreased
33.3%
1/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Investigations
Blood Sodium Decreased
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Investigations
Electrocardiogram Qt Prolonged
0.00%
0/3
28.6%
2/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Investigations
Haemoglobin
0.00%
0/3
14.3%
1/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Investigations
Haemoglobin Decreased
33.3%
1/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Investigations
Platelet Count Decreased
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
6.2%
1/16
Investigations
Weight Decreased
0.00%
0/3
14.3%
1/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Investigations
Activated Partial Thromboplastin Time Prolonged
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Investigations
Blood Potassium
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Investigations
Blood Pressure Increased
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Investigations
International Normalised Ratio Increased
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Investigations
Troponin
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Nervous system disorders
Headache
0.00%
0/3
42.9%
3/7
33.3%
3/9
33.3%
2/6
62.5%
10/16
Nervous system disorders
Dizziness
0.00%
0/3
14.3%
1/7
11.1%
1/9
33.3%
2/6
0.00%
0/16
Nervous system disorders
Cerebral Haematoma
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Nervous system disorders
Dysgeusia
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Nervous system disorders
Neuropathy Peripheral
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Nervous system disorders
Peripheral Motor Neuropathy
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Nervous system disorders
Peripheral Sensory Neuropathy
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Nervous system disorders
Spinal Cord Compression
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Infections and infestations
Urinary Tract Infection
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
18.8%
3/16
Infections and infestations
Device Related Infection
0.00%
0/3
0.00%
0/7
11.1%
1/9
16.7%
1/6
6.2%
1/16
Infections and infestations
Pneumonia
0.00%
0/3
0.00%
0/7
0.00%
0/9
33.3%
2/6
6.2%
1/16
Infections and infestations
Gastroenteritis
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
6.2%
1/16
Infections and infestations
Infection
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Infections and infestations
Lung Infection
0.00%
0/3
0.00%
0/7
22.2%
2/9
0.00%
0/6
0.00%
0/16
Infections and infestations
Oral Candidiasis
0.00%
0/3
28.6%
2/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Infections and infestations
Abdominal Abscess
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Infections and infestations
Bacteraemia
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Infections and infestations
Bronchitis
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Infections and infestations
Cystitis
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Infections and infestations
Herpes Zoster
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Infections and infestations
Neutropenic Sepsis
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Infections and infestations
Subcutaneous Abscess
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Infections and infestations
Tinea Pedis
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Infections and infestations
Wound Infection
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
Musculoskeletal and connective tissue disorders
Muscle Spasms
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
18.8%
3/16
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/3
28.6%
2/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Musculoskeletal and connective tissue disorders
Back Pain
0.00%
0/3
0.00%
0/7
22.2%
2/9
0.00%
0/6
0.00%
0/16
Musculoskeletal and connective tissue disorders
Neck Pain
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
6.2%
1/16
Musculoskeletal and connective tissue disorders
Pain In Extremity
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Musculoskeletal and connective tissue disorders
Arthropathy
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Musculoskeletal and connective tissue disorders
Muscle Rigidity
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Musculoskeletal and connective tissue disorders
Soft Tissue Disorder
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Vascular disorders
Hot Flush
0.00%
0/3
0.00%
0/7
22.2%
2/9
33.3%
2/6
0.00%
0/16
Vascular disorders
Flushing
0.00%
0/3
28.6%
2/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Vascular disorders
Deep Vein Thrombosis
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
12.5%
2/16
Vascular disorders
Hypertension
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
6.2%
1/16
Vascular disorders
Hypotension
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Vascular disorders
Phlebitis
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Eye disorders
Dry Eye
0.00%
0/3
14.3%
1/7
11.1%
1/9
16.7%
1/6
12.5%
2/16
Eye disorders
Lacrimation Increased
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Eye disorders
Conjunctivitis
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Eye disorders
Vision Blurred
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
Cardiac disorders
Arrhythmia
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
6.2%
1/16
Cardiac disorders
Palpitations
0.00%
0/3
14.3%
1/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
Cardiac disorders
Angina Pectoris
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Cardiac disorders
Myocardial Infarction
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Cardiac disorders
Myocardial Ischaemia
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Psychiatric disorders
Insomnia
0.00%
0/3
14.3%
1/7
22.2%
2/9
0.00%
0/6
6.2%
1/16
Psychiatric disorders
Anxiety
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Psychiatric disorders
Restlessness
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
Renal and urinary disorders
Urinary Retention
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Renal and urinary disorders
Bladder Pain
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Renal and urinary disorders
Bladder Spasm
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Renal and urinary disorders
Haematuria
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Renal and urinary disorders
Micturition Urgency
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Renal and urinary disorders
Pollakiuria
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Renal and urinary disorders
Renal Pain
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Immune system disorders
Hypersensitivity
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
12.5%
2/16
Injury, poisoning and procedural complications
Fall
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Injury, poisoning and procedural complications
Open wound
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16
Reproductive system and breast disorders
Erectile Dysfunction
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
Reproductive system and breast disorders
Vaginal Haemorrhage
0.00%
0/3
14.3%
1/7
0.00%
0/9
0.00%
0/6
0.00%
0/16
Ear and labyrinth disorders
Tinnitus
0.00%
0/3
0.00%
0/7
0.00%
0/9
16.7%
1/6
0.00%
0/16
Hepatobiliary disorders
Hepatic Steatosis
0.00%
0/3
0.00%
0/7
11.1%
1/9
0.00%
0/6
0.00%
0/16
Social circumstances
Abstains From Alcohol
0.00%
0/3
0.00%
0/7
0.00%
0/9
0.00%
0/6
6.2%
1/16

Additional Information

PRS Administrator Gunilla Emanuelson

Topotarget A/S

Phone: +45 39 17 83 92

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60