Trial Outcomes & Findings for Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer (NCT NCT01705691)
NCT ID: NCT01705691
Last Updated: 2021-10-06
Results Overview
Percentage of patients with no histologic evidence of cancer in breast and axillary lymph nodes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
At the time of surgery approximately 24 to 28 weeks.
Results posted on
2021-10-06
Participant Flow
One patient randomly assigned to Arm 2 withdrew consent before receiving protocol therapy.
Participant milestones
| Measure |
Arm 1: Paclitaxel Then AC
Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
Arm 2: Eribulin Then AC
Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
30
|
|
Overall Study
COMPLETED
|
16
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Arm 1: Paclitaxel Then AC
Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
Arm 2: Eribulin Then AC
Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1: Paclitaxel Then AC
n=19 Participants
Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
Arm 2: Eribulin Then AC
n=30 Participants
Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.47 years
STANDARD_DEVIATION 10.73 • n=93 Participants
|
49.17 years
STANDARD_DEVIATION 13.21 • n=4 Participants
|
49.67 years
STANDARD_DEVIATION 12.21 • n=27 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Unknown Ethnicity
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: At the time of surgery approximately 24 to 28 weeks.Population: 1 patient in Arm 1 was not analyzed due to inoperable, progressive disease. 2 patients in Arm 2 are missing data.
Percentage of patients with no histologic evidence of cancer in breast and axillary lymph nodes.
Outcome measures
| Measure |
Arm 1: Paclitaxel Then AC
n=19 Participants
Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
Arm 2: Eribulin Then AC
n=30 Participants
Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
|---|---|---|
|
Pathologic Complete Response Rate (ypCR) Following Neoadjuvant Therapy in Breast and Axillary Lymph Nodes
|
26.3 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: At the time of surgery approximately 24 to 28 weeks.Population: 1 patient in Arm 1 was not analyzed due to inoperable, progressive disease. 2 patients in Arm 2 are missing data.
Percentage of patients with no histologic evidence of cancer in axillary lymph nodes.
Outcome measures
| Measure |
Arm 1: Paclitaxel Then AC
n=19 Participants
Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
Arm 2: Eribulin Then AC
n=30 Participants
Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
|---|---|---|
|
ypCR Nodes
|
42.1 percentage of participants
|
30.0 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after initiation of study therapyPercentage of patients with clinical complete response (no significant enhancement on MR images) or clinical partial response (at least 30% decrease in the maximal diameter of the tumor)
Outcome measures
| Measure |
Arm 1: Paclitaxel Then AC
n=19 Participants
Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
Arm 2: Eribulin Then AC
n=30 Participants
Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
|---|---|---|
|
Clinical Overall Response (cOR)(Complete and Partial) Assessed by MRI at the Completion of WP or Eribulin (Before AC)
|
58 percentage of participants
|
40 percentage of participants
|
SECONDARY outcome
Timeframe: At approximately 24 to 28 weeks from initiation of study therapyPopulation: 1 patient in Arm 1 and 3 patients in Arm 2 are missing data. The N=18 for the paclitaxel group is because analysis was done on only patients with a palpable lesion at baseline.
The number of patients with clinical complete response.
Outcome measures
| Measure |
Arm 1: Paclitaxel Then AC
n=18 Participants
Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
Arm 2: Eribulin Then AC
n=30 Participants
Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
|---|---|---|
|
Clinical Complete Response (ycCR) Following Neoadjuvant Therapy Assessed by Physical Exam at the Completion of Neoadjuvant Chemotherapy
|
8 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Assessed through 24 months from randomizationThe percentage of patients free from recurrence at 24 months.
Outcome measures
| Measure |
Arm 1: Paclitaxel Then AC
n=19 Participants
Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
Arm 2: Eribulin Then AC
n=30 Participants
Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
|---|---|---|
|
Recurrence Free Interval (RFI): The Time to Occurrence of Inoperable Progressive Disease and Local, Regional, and Distant Recurrence.
|
83.6 percentage of patients
Interval 57.3 to 94.4
|
80.7 percentage of patients
Interval 59.6 to 91.5
|
SECONDARY outcome
Timeframe: Assessed through 24 months from randomizationPercentage of patients alive at 24 months.
Outcome measures
| Measure |
Arm 1: Paclitaxel Then AC
n=19 Participants
Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
Arm 2: Eribulin Then AC
n=30 Participants
Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
|---|---|---|
|
2-year Overall Survival (OS): Death From Any Cause From Time of Randomization Through 2 Years After Randomization.
|
88.5 percentage of patients
Interval 61.4 to 97.0
|
92.6 percentage of patients
Interval 73.5 to 98.1
|
SECONDARY outcome
Timeframe: Assessed through 24 months from randomizationPopulation: Please refer to the AE section for more detail.
Total patients with at least 1 AE.
Outcome measures
| Measure |
Arm 1: Paclitaxel Then AC
n=19 Participants
Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
Arm 2: Eribulin Then AC
n=30 Participants
Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
|---|---|---|
|
Adverse Events Experienced by Participants as a Measure of Toxicity.
|
19 participants
|
30 participants
|
Adverse Events
Arm 1: Paclitaxel Then AC
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Arm 2: Eribulin Then AC
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Paclitaxel Then AC
n=19 participants at risk
Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
Arm 2: Eribulin Then AC
n=30 participants at risk
Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
3.3%
1/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
0.00%
0/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
3.3%
1/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Gastrointestinal disorders
Colitis
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
0.00%
0/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
3.3%
1/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
3.3%
1/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Vascular disorders
Haematoma
|
0.00%
0/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
3.3%
1/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
Other adverse events
| Measure |
Arm 1: Paclitaxel Then AC
n=19 participants at risk
Paclitaxel 80 mg/m2 IV weekly for 12 doses followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Paclitaxel: 80 mg/m2 IV over 60 minutes weekly for 12 weeks
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
Arm 2: Eribulin Then AC
n=30 participants at risk
Eribulin 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle for 4 cycles, followed by doxorubicin and cyclophosphamide IV every 21 days for 4 cycles
Eribulin: 1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles
Doxorubicin: 60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
Cyclophosphamide: 600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
|
|---|---|---|
|
General disorders
Fatigue
|
78.9%
15/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
73.3%
22/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
General disorders
Oedema peripheral
|
15.8%
3/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
3.3%
1/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
General disorders
Pain
|
15.8%
3/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
3.3%
1/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
General disorders
Pyrexia
|
10.5%
2/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
General disorders
Axillary pain
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
General disorders
Chills
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
General disorders
Influenza like illness
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
General disorders
Mucosal inflammation
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Gastrointestinal disorders
Nausea
|
52.6%
10/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
63.3%
19/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Gastrointestinal disorders
Constipation
|
26.3%
5/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
40.0%
12/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
42.1%
8/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
13.3%
4/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Gastrointestinal disorders
Vomiting
|
21.1%
4/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
13.3%
4/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
15.8%
3/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
13.3%
4/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Gastrointestinal disorders
Stomatitis
|
10.5%
2/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
16.7%
5/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
10.0%
3/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
36.8%
7/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
53.3%
16/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Leukopenia
|
52.6%
10/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
36.7%
11/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Neutropenia
|
52.6%
10/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
36.7%
11/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
21.1%
4/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Nervous system disorders
Headache
|
26.3%
5/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
40.0%
12/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
31.6%
6/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
16.7%
5/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Nervous system disorders
Dysgeusia
|
10.5%
2/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
23.3%
7/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Nervous system disorders
Dizziness
|
15.8%
3/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Nervous system disorders
Paraesthesia
|
15.8%
3/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Nervous system disorders
Hypoaesthesia
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
10.0%
3/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
20.0%
6/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
16.7%
5/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.8%
3/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
10.0%
3/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
13.3%
4/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.5%
2/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
3.3%
1/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.1%
4/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
20.0%
6/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.5%
2/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
13.3%
4/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
10.5%
2/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
3.3%
1/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.5%
2/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
3.3%
1/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
10.0%
3/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.5%
2/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
20.0%
6/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.8%
3/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
13.3%
4/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
13.3%
4/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
13.3%
4/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Investigations
Alanine aminotransferase increased
|
10.5%
2/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
50.0%
15/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
23.3%
7/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
16.7%
5/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.5%
2/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
2/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
15.8%
3/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
0.00%
0/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
10.0%
3/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Acne
|
10.5%
2/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
0.00%
0/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Psychiatric disorders
Insomnia
|
21.1%
4/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
20.0%
6/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
20.0%
6/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
10.0%
3/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Infections and infestations
Urinary tract infection
|
15.8%
3/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
0.00%
0/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Reproductive system and breast disorders
Breast pain
|
15.8%
3/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
16.7%
5/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
13.3%
4/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Eye disorders
Lacrimation increased
|
10.5%
2/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
3.3%
1/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Eye disorders
Vision blurred
|
0.00%
0/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Cardiac disorders
Palpitations
|
10.5%
2/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
10.0%
3/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/19 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
6.7%
2/30 • Emergent Adverse Events are those reported on or after the first administration and until 30 days after the last dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60