Trial Outcomes & Findings for A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC) (NCT NCT01240590)
NCT ID: NCT01240590
Last Updated: 2017-04-10
Results Overview
MTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
3 weeks
Results posted on
2017-04-10
Participant Flow
The phase II portion was not completed because it was impossible to recruit.
Participant milestones
| Measure |
Level -1: Cisplatin + Crolibulin
75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
|
Level 1: Cisplatin + Crolibulin
75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
|
Level 2: Cisplatin + Crolibulin
100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
|
Level 3: Cisplatin + Crolibulin
100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
|
Level 4: Cisplatin
100mg/m(2) Cisplatin Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
|
|---|---|---|---|---|---|
|
Phase I
STARTED
|
0
|
6
|
3
|
0
|
0
|
|
Phase I
COMPLETED
|
0
|
6
|
0
|
0
|
0
|
|
Phase I
NOT COMPLETED
|
0
|
0
|
3
|
0
|
0
|
|
Phase II
STARTED
|
0
|
0
|
0
|
17
|
1
|
|
Phase II
COMPLETED
|
0
|
0
|
0
|
15
|
0
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Level -1: Cisplatin + Crolibulin
75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
|
Level 1: Cisplatin + Crolibulin
75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
|
Level 2: Cisplatin + Crolibulin
100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
|
Level 3: Cisplatin + Crolibulin
100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
|
Level 4: Cisplatin
100mg/m(2) Cisplatin Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
|
|---|---|---|---|---|---|
|
Phase I
Refused further treatment
|
0
|
0
|
3
|
0
|
0
|
|
Phase II
Refused further treatment
|
0
|
0
|
0
|
2
|
1
|
Baseline Characteristics
A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC)
Baseline characteristics by cohort
| Measure |
Ph I Level -1: Cisplatin + Crolibulin
75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
|
Ph I Level 1: Cisplatin + Crolibulin
n=6 Participants
75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
|
Ph I Level 2: Cisplatin + Crolibulin
n=3 Participants
100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
|
Ph II Level 3: Cisplatin + Crolibulin
n=17 Participants
100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
|
Ph II Level 4: Cisplatin
n=1 Participants
100mg/m(2) Cisplatin
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
—
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
|
Age, Continuous
|
—
|
68.03 years
STANDARD_DEVIATION 8.09 • n=7 Participants
|
51.53 years
STANDARD_DEVIATION 7.45 • n=5 Participants
|
58.76 years
STANDARD_DEVIATION 8.44 • n=4 Participants
|
70.3 years
STANDARD_DEVIATION 0 • n=21 Participants
|
60.45 years
STANDARD_DEVIATION 9.42 • n=8 Participants
|
|
Sex: Female, Male
Female
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
—
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
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
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
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
|
|
Race (NIH/OMB)
Black or African American
|
—
|
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
|
|
Race (NIH/OMB)
White
|
—
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
—
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 3 weeksMTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE).
Outcome measures
| Measure |
All Participants
n=9 Participants
All participants who received at least one dose of 75-100 mg/m(2) cisplatin intravenously.
|
Ph II Level 4: Cisplatin
100mg/m(2) Cisplatin
|
Ph I Level 2: Cisplatin + Crolibulin
100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
|
Ph II Level 3: Cisplatin + Crolibulin
100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
|
Ph II Level 4: Cisplatin
100mg/m(2) Cisplatin
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Cisplatin (Phase I)
|
100 mg/m^2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 weeksMTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE).
Outcome measures
| Measure |
All Participants
n=9 Participants
All participants who received at least one dose of 75-100 mg/m(2) cisplatin intravenously.
|
Ph II Level 4: Cisplatin
100mg/m(2) Cisplatin
|
Ph I Level 2: Cisplatin + Crolibulin
100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
|
Ph II Level 3: Cisplatin + Crolibulin
100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
|
Ph II Level 4: Cisplatin
100mg/m(2) Cisplatin
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Crolibulin (Phase I)
|
20 mg/m^2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: The outcome was not met because the patients died and were not scanned before their death.
Progression free survival (PFS) is defined as the duration of time from start of study treatment to time of progression. Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as: Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 years, 6 months and 26 daysHere is the number of participants with serious and non-serious adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
All Participants
All participants who received at least one dose of 75-100 mg/m(2) cisplatin intravenously.
|
Ph II Level 4: Cisplatin
n=6 Participants
100mg/m(2) Cisplatin
|
Ph I Level 2: Cisplatin + Crolibulin
n=3 Participants
100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
|
Ph II Level 3: Cisplatin + Crolibulin
n=17 Participants
100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
|
Ph II Level 4: Cisplatin
n=1 Participants
100mg/m(2) Cisplatin
|
|---|---|---|---|---|---|
|
Number of Participants With Serious and Non-Serious Adverse Events (Phase I & II)
|
—
|
6 participants
|
1 participants
|
16 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 4.5 yearsEnrolled participants who had surgical procedures deemed medically necessary for their clinical care.
Outcome measures
| Measure |
All Participants
All participants who received at least one dose of 75-100 mg/m(2) cisplatin intravenously.
|
Ph II Level 4: Cisplatin
n=6 Participants
100mg/m(2) Cisplatin
|
Ph I Level 2: Cisplatin + Crolibulin
n=3 Participants
100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
|
Ph II Level 3: Cisplatin + Crolibulin
n=17 Participants
100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
|
Ph II Level 4: Cisplatin
n=1 Participants
100mg/m(2) Cisplatin
|
|---|---|---|---|---|---|
|
Number of Participants Who Underwent Medically-Necessary Interventions
Gastrostomy
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Underwent Medically-Necessary Interventions
Trachesostomy
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Underwent Medically-Necessary Interventions
Cholecystectomy
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Underwent Medically-Necessary Interventions
No medically-necessary procedures
|
0 Participants
|
5 Participants
|
3 Participants
|
15 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 21 daysPopulation: This outcome measure was not analyzed because few if any re-assessments were done, thus there was not enough data to assess the growth rate constant on the patients.
Difference in time (days) required for the treated tumors to reach a predetermined target size.
Outcome measures
Outcome data not reported
Adverse Events
Ph I Level: -1 Cisplatin & Crolibulin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ph I Level: 1 Cisplatin & Crolibulin
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Ph I Level: 2 Cisplatin & Crolibulin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ph II Level: 3 Cisplatin & Crolibulin
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Ph II Level: 4 Cisplatin
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ph I Level: -1 Cisplatin & Crolibulin
75 mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
|
Ph I Level: 1 Cisplatin & Crolibulin
n=6 participants at risk
75 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
|
Ph I Level: 2 Cisplatin & Crolibulin
n=3 participants at risk
100 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
|
Ph II Level: 3 Cisplatin & Crolibulin
n=17 participants at risk
100 mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
|
Ph II Level: 4 Cisplatin
n=1 participants at risk
100 mg/m(2) Cisplatin
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Investigations
Lipase increased
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Gastrointestinal disorders
Pancreatitis
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Infections and infestations
Bronchial infection
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Investigations
Creatinine increased
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Nervous system disorders
Dizziness
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
General disorders
Edema limbs
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
General disorders
Fever
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
11.8%
2/17 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
General disorders
Neck edema
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Vascular disorders
Thromboembolic event
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Nervous system disorders
Tremor
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
100.0%
1/1 • Number of events 1 • 4 years, 6 months and 26 days
|
|
Gastrointestinal disorders
Dysphagia
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
100.0%
1/1 • Number of events 1 • 4 years, 6 months and 26 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
100.0%
1/1 • Number of events 1 • 4 years, 6 months and 26 days
|
Other adverse events
| Measure |
Ph I Level: -1 Cisplatin & Crolibulin
75 mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
|
Ph I Level: 1 Cisplatin & Crolibulin
n=6 participants at risk
75 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
|
Ph I Level: 2 Cisplatin & Crolibulin
n=3 participants at risk
100 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
|
Ph II Level: 3 Cisplatin & Crolibulin
n=17 participants at risk
100 mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
|
Ph II Level: 4 Cisplatin
n=1 participants at risk
100 mg/m(2) Cisplatin
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Gastrointestinal disorders
Abdominal pain
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Investigations
Activated partial thromboplastin time prolonged
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Renal and urinary disorders
Acute kidney injury
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Investigations
Alanine aminotransferase increased
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
35.3%
6/17 • Number of events 7 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Investigations
Alkaline phosphatase increased
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Alkalosis
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • 4 years, 6 months and 26 days
|
50.0%
3/6 • Number of events 5 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
64.7%
11/17 • Number of events 52 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Anorexia
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
11.8%
2/17 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Psychiatric disorders
Anxiety
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Investigations
Aspartate aminotransferase increased
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
41.2%
7/17 • Number of events 8 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
11.8%
2/17 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Eye disorders
Blurred vision
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Investigations
Cardiac troponin I increased
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
General disorders
Chills
|
—
0/0 • 4 years, 6 months and 26 days
|
33.3%
2/6 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Renal and urinary disorders
Chronic kidney disease
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • 4 years, 6 months and 26 days
|
33.3%
2/6 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
11.8%
2/17 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Investigations
Creatinine increased
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
47.1%
8/17 • Number of events 37 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Dehydration
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
23.5%
4/17 • Number of events 4 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Nervous system disorders
Dizziness
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Nervous system disorders
Dysgeusia
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Gastrointestinal disorders
Dyspepsia
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
11.8%
2/17 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
11.8%
2/17 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
General disorders
Edema limbs
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
58.8%
10/17 • Number of events 33 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
General disorders
Fatigue
|
—
0/0 • 4 years, 6 months and 26 days
|
33.3%
2/6 • Number of events 4 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
17.6%
3/17 • Number of events 3 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
General disorders
Fever
|
—
0/0 • 4 years, 6 months and 26 days
|
33.3%
2/6 • Number of events 3 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
17.6%
3/17 • Number of events 3 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
General disorders
Flu like symptoms
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
General disorders
General disorders and administration site conditions-Other, specify
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Investigations
GGT increased
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Nervous system disorders
Headache
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
17.6%
3/17 • Number of events 3 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Ear and labyrinth disorders
Hearing impaired
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Vascular disorders
Hematoma
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Renal and urinary disorders
hemoglobinuria
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 2 • 4 years, 6 months and 26 days
|
33.3%
1/3 • Number of events 1 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
17.6%
3/17 • Number of events 3 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
17.6%
3/17 • Number of events 4 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 4 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
17.6%
3/17 • Number of events 8 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Hypernatremia
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Vascular disorders
Hypertension
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
58.8%
10/17 • Number of events 68 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 7 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
—
0/0 • 4 years, 6 months and 26 days
|
33.3%
2/6 • Number of events 5 • 4 years, 6 months and 26 days
|
33.3%
1/3 • Number of events 1 • 4 years, 6 months and 26 days
|
52.9%
9/17 • Number of events 16 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
17.6%
3/17 • Number of events 4 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
17.6%
3/17 • Number of events 4 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
—
0/0 • 4 years, 6 months and 26 days
|
50.0%
3/6 • Number of events 4 • 4 years, 6 months and 26 days
|
33.3%
1/3 • Number of events 1 • 4 years, 6 months and 26 days
|
47.1%
8/17 • Number of events 17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
—
0/0 • 4 years, 6 months and 26 days
|
66.7%
4/6 • Number of events 5 • 4 years, 6 months and 26 days
|
33.3%
1/3 • Number of events 1 • 4 years, 6 months and 26 days
|
64.7%
11/17 • Number of events 22 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
11.8%
2/17 • Number of events 4 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Infections and infestations
Infections and infestations - Other, specify (Oral thrush)
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
General disorders
Infusion related reaction
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
General disorders
Infusion site extravasation
|
—
0/0 • 4 years, 6 months and 26 days
|
33.3%
2/6 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Psychiatric disorders
Insomnia
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Investigations
Lipase increased
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Investigations
Lymphocyte count decreased
|
—
0/0 • 4 years, 6 months and 26 days
|
50.0%
3/6 • Number of events 9 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
52.9%
9/17 • Number of events 28 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
General disorders
Malaise
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify (Amylase)
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • 4 years, 6 months and 26 days
|
33.3%
2/6 • Number of events 4 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
41.2%
7/17 • Number of events 12 • 4 years, 6 months and 26 days
|
100.0%
1/1 • Number of events 1 • 4 years, 6 months and 26 days
|
|
Investigations
Neutrophil count decreased
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
23.5%
4/17 • Number of events 6 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
General disorders
Pain
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
17.6%
3/17 • Number of events 5 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Nervous system disorders
Peripheral motor neuropathy
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
11.8%
2/17 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
—
0/0 • 4 years, 6 months and 26 days
|
33.3%
2/6 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Investigations
Platelet count decreased
|
—
0/0 • 4 years, 6 months and 26 days
|
33.3%
2/6 • Number of events 4 • 4 years, 6 months and 26 days
|
33.3%
1/3 • Number of events 1 • 4 years, 6 months and 26 days
|
52.9%
9/17 • Number of events 21 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
11.8%
2/17 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Cardiac disorders
Sinus bradycardia
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
11.8%
2/17 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Cardiac disorders
Sinus tachycardia
|
—
0/0 • 4 years, 6 months and 26 days
|
33.3%
2/6 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
11.8%
2/17 • Number of events 4 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Nervous system disorders
Syncope
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Vascular disorders
Thromboembolic event
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
11.8%
2/17 • Number of events 2 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Ear and labyrinth disorders
Tinnitus
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
11.8%
2/17 • Number of events 4 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Infections and infestations
Upper respiratory infection
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Renal and urinary disorders
Urinary tract pain
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
0.00%
0/17 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • 4 years, 6 months and 26 days
|
0.00%
0/6 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
23.5%
4/17 • Number of events 5 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Investigations
Weight loss
|
—
0/0 • 4 years, 6 months and 26 days
|
16.7%
1/6 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
5.9%
1/17 • Number of events 1 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
|
Investigations
White blood cell decreased
|
—
0/0 • 4 years, 6 months and 26 days
|
33.3%
2/6 • Number of events 3 • 4 years, 6 months and 26 days
|
0.00%
0/3 • 4 years, 6 months and 26 days
|
11.8%
2/17 • Number of events 3 • 4 years, 6 months and 26 days
|
0.00%
0/1 • 4 years, 6 months and 26 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place