Trial Outcomes & Findings for Food Effect Study of Alisertib (MLN8237) in Participants With Advanced Solid Tumors or Lymphomas (NCT NCT01898078)
NCT ID: NCT01898078
Last Updated: 2019-06-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Results posted on
2019-06-21
Participant Flow
Participants took part in the study at 3 investigative sites in the United States from 16 July 2013 to 24 January 2017. Data cut-off for the primary analysis was 05 March 2014.
Participants with a diagnosis of advanced solid tumors or lymphomas were enrolled to crossover fashion to receive alisertib 50 mg enteric-coated tablet (ECT), orally in fasted or fed state in Cycles 1 and 2.
Participant milestones
| Measure |
Alisertib 50 mg Fed + Fasted
Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
|
Alisertib 50 mg Fasted + Fed
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
Alisertib 50 mg Fed + Fasted
Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
|
Alisertib 50 mg Fasted + Fed
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
|
|---|---|---|
|
Overall Study
Progressive Disease
|
1
|
5
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Symptomatic Deterioration
|
2
|
0
|
|
Overall Study
Reason not Specified
|
0
|
1
|
Baseline Characteristics
Food Effect Study of Alisertib (MLN8237) in Participants With Advanced Solid Tumors or Lymphomas
Baseline characteristics by cohort
| Measure |
Alisertib 50 mg Fed + Fasted
n=13 Participants
Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
|
Alisertib 50 mg Fasted + Fed
n=13 Participants
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 10.15 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 12.64 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 11.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Height
|
166.9 cm
STANDARD_DEVIATION 14.34 • n=5 Participants
|
165.3 cm
STANDARD_DEVIATION 11.32 • n=7 Participants
|
166.1 cm
STANDARD_DEVIATION 12.68 • n=5 Participants
|
|
Weight
|
73.59 kg
STANDARD_DEVIATION 15.484 • n=5 Participants
|
78.37 kg
STANDARD_DEVIATION 20.183 • n=7 Participants
|
75.98 kg
STANDARD_DEVIATION 17.792 • n=5 Participants
|
PRIMARY outcome
Timeframe: Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: Pharmacokinetic (PK) population included participants with sufficient dosing data and PK concentration-time data to reliably estimate the PK parameters.
Outcome measures
| Measure |
Alisertib 50 mg Fed
n=22 Participants
Alisertib 50 mg, ECT, orally, in fed state, once on Day 1 in Cycles 1 and 2.
|
Alisertib 50 mg Fasted
n=22 Participants
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1 in Cycles 1 and 2.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration of Alisertib
|
1338.6 nM
Standard Deviation 487.25
|
1354.5 nM
Standard Deviation 432.17
|
PRIMARY outcome
Timeframe: Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: PK population included participants with sufficient dosing data and PK concentration-time data to reliably estimate the PK parameters.
Outcome measures
| Measure |
Alisertib 50 mg Fed
n=22 Participants
Alisertib 50 mg, ECT, orally, in fed state, once on Day 1 in Cycles 1 and 2.
|
Alisertib 50 mg Fasted
n=22 Participants
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1 in Cycles 1 and 2.
|
|---|---|---|
|
AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alisertib
|
24645.5 hr*nM
Standard Deviation 12467.39
|
20797.7 hr*nM
Standard Deviation 8847.69
|
PRIMARY outcome
Timeframe: Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: PK population included participants with sufficient dosing data and PK concentration-time data to reliably estimate the PK parameters. Here, number of participants analysed are the participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Alisertib 50 mg Fed
n=16 Participants
Alisertib 50 mg, ECT, orally, in fed state, once on Day 1 in Cycles 1 and 2.
|
Alisertib 50 mg Fasted
n=14 Participants
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1 in Cycles 1 and 2.
|
|---|---|---|
|
AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity of Alisertib
|
24537.5 hr*nM
Standard Deviation 9882.10
|
22771.4 hr*nM
Standard Deviation 10206.21
|
SECONDARY outcome
Timeframe: From first dose through 30 days after the last dose of study drug (up to 225 days)Population: Safety population included all enrolled participants who received at least one dose of study drug. According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Outcome measures
| Measure |
Alisertib 50 mg Fed
n=13 Participants
Alisertib 50 mg, ECT, orally, in fed state, once on Day 1 in Cycles 1 and 2.
|
Alisertib 50 mg Fasted
n=13 Participants
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1 in Cycles 1 and 2.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
13 Participants
|
13 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From first dose through 30 days after the last dose of study drug (up to 225 days)Population: Safety population included all enrolled participants who received at least one dose of study drug. According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
The number of participants with any clinical significant change in safety laboratory values collected throughout the study.
Outcome measures
| Measure |
Alisertib 50 mg Fed
n=13 Participants
Alisertib 50 mg, ECT, orally, in fed state, once on Day 1 in Cycles 1 and 2.
|
Alisertib 50 mg Fasted
n=13 Participants
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1 in Cycles 1 and 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
Neutropenia
|
10 Participants
|
8 Participants
|
|
Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
Anaemia
|
5 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
Leukopenia
|
5 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
Thrombocytopenia
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
Hypokalaemia
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
Hyperbilirubinaemia
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
Neutrophil count decreased
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
Lymphopenia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
Hyperkalaemia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
Hypomagnesaemia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
Aspartate aminotransferase increased
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
Blood bilirubin increased
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose through 30 days after the last dose of study drug (up to 225 days)Population: Safety population included all enrolled participants who received at least one dose of study drug. According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
The number of participants with any clinical significant change in vital signs (sitting diastolic and systolic blood pressure, heart rate, and temperature) were collected throughout the study.
Outcome measures
| Measure |
Alisertib 50 mg Fed
n=13 Participants
Alisertib 50 mg, ECT, orally, in fed state, once on Day 1 in Cycles 1 and 2.
|
Alisertib 50 mg Fasted
n=13 Participants
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1 in Cycles 1 and 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change in Vital Sign Reported as AEs
Hypertension
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Change in Vital Sign Reported as AEs
Hypotension
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Change in Vital Sign Reported as AEs
Tachycardia
|
0 Participants
|
1 Participants
|
Adverse Events
Alisertib 50 mg Fed + Fasted
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Alisertib 50 mg Fasted + Fed
Serious events: 7 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Alisertib 50 mg Fed + Fasted
n=13 participants at risk
Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
|
Alisertib 50 mg Fasted + Fed
n=13 participants at risk
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Bacteraemia
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Pneumonia streptococcal
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Streptococcal sepsis
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Psychiatric disorders
Mental status changes
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Nervous system disorders
Toxic encephalopathy
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
General disorders
Pyrexia
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
Other adverse events
| Measure |
Alisertib 50 mg Fed + Fasted
n=13 participants at risk
Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
|
Alisertib 50 mg Fasted + Fed
n=13 participants at risk
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Eye disorders
Cataract
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Eye disorders
Eyelid cyst
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Investigations
Neutrophil count decreased
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Investigations
Blood bilirubin increased
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Injury, poisoning and procedural complications
Fall
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Renal and urinary disorders
Pollakiuria
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Renal and urinary disorders
Urinary hesitation
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Psychiatric disorders
Confusional state
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Psychiatric disorders
Hallucination
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Urinary tract infection
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Sinusitis
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Candida infection
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Cystitis
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Lung abscess
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Blood and lymphatic system disorders
Neutropenia
|
84.6%
11/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
61.5%
8/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Blood and lymphatic system disorders
Anaemia
|
46.2%
6/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
30.8%
4/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Blood and lymphatic system disorders
Leukopenia
|
38.5%
5/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
23.1%
3/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
23.1%
3/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
23.1%
3/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Nervous system disorders
Somnolence
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Nervous system disorders
Neuropathy peripheral
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Nervous system disorders
Memory impairment
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Nervous system disorders
Metabolic encephalopathy
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.1%
3/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
30.8%
4/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
23.1%
3/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
General disorders
Fatigue
|
61.5%
8/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
23.1%
3/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
General disorders
Pyrexia
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
38.5%
5/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
General disorders
Asthenia
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
23.1%
3/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
General disorders
Oedema peripheral
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
General disorders
Chills
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
General disorders
Local swelling
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
General disorders
Catheter site erythema
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
General disorders
Catheter site haemorrhage
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
General disorders
Catheter site pain
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
General disorders
Infusion site vesicles
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
General disorders
Localised oedema
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
23.1%
3/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
23.1%
3/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
23.1%
3/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoe
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Stomatitis
|
23.1%
3/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
61.5%
8/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
3/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
53.8%
7/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Diarrhoea
|
38.5%
5/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
30.8%
4/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
38.5%
5/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
23.1%
3/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Inguinal hernia
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Inguinal mass
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
61.5%
8/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
53.8%
7/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
15.4%
2/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Rash maculovesicular
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.7%
1/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
0.00%
0/13 • From first dose through 30 days after the last dose of study drug (up to 225 days)
According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
- Publication restrictions are in place
Restriction type: OTHER