Trial Outcomes & Findings for Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC) (NCT NCT02753595)
NCT ID: NCT02753595
Last Updated: 2020-07-13
Results Overview
The RP2D was the maximum tolerated dose (MTD) or less. The MTD was determined as the dose level (1, 0) at which less than or equal to (\<=) 1 of 6 evaluable participants experienced dose limiting toxicity (DLT) within the first 21 days of treatment (end of Cycle 1). Upon determination of RP2D in Cycle 1 of Phase 1b, RP2D was to be confirmed in Phase 1b-expansion Part.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to Cycle 28 (Cycle Length= 21 days)
Results posted on
2020-07-13
Participant Flow
Participants took part in the study at 4 investigative sites in the United States from 13 Jul 2016 to 16 Aug 2019. A total of 25 participants were screened and enrolled (signed informed consent form), of which 11 were screen failures, and 14 were treated.
Study terminated early during Phase 1b Expansion Part and before initiating Phase 2 due to poor accrual. Data reported is based on initial dosing levels given to participants during Phase 1b. Combined data for participants who received Dose level 0 during determination of RP2D and confirmation of RP2D (Expansion Part) are reported as planned.
Participant milestones
| Measure |
Phase 1b: Dose Level 1
Participants received PEGylated recombinant human hyaluronidase (PEGPH20) 3.0 microgram per kilogram (mcg/kg), infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 milligram per square meter (mg/m\^2), infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle up to Cycle 28 (Dose level 1).
|
Phase 1b: Dose Level 0 and Expansion Part
Participants received PEGPH20 1.6 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m\^2, infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle for up to Cycle 28 (Dose Level 0). After the determination of RP2D at this dosing level in Cycle 1 of Phase 1b, additional participants were enrolled in this dosing level for the confirmation of the RP2D in the Expansion Part for up to Cycle 28.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
9
|
|
Overall Study
COMPLETED
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Phase 1b: Dose Level 1
Participants received PEGylated recombinant human hyaluronidase (PEGPH20) 3.0 microgram per kilogram (mcg/kg), infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 milligram per square meter (mg/m\^2), infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle up to Cycle 28 (Dose level 1).
|
Phase 1b: Dose Level 0 and Expansion Part
Participants received PEGPH20 1.6 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m\^2, infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle for up to Cycle 28 (Dose Level 0). After the determination of RP2D at this dosing level in Cycle 1 of Phase 1b, additional participants were enrolled in this dosing level for the confirmation of the RP2D in the Expansion Part for up to Cycle 28.
|
|---|---|---|
|
Overall Study
Sponsor termination
|
2
|
2
|
Baseline Characteristics
Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC)
Baseline characteristics by cohort
| Measure |
Phase 1b: Dose Level 1
n=5 Participants
Participants received PEGPH20 3.0 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m\^2, infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle up to Cycle 28 (Dose level 1).
|
Phase 1b: Dose Level 0 and Expansion Part
n=9 Participants
Participants received PEGPH20 1.6 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m\^2, infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle for up to Cycle 28 (Dose Level 0). After the determination of RP2D at this dosing level in Cycle 1 of Phase 1b, additional participants were enrolled in this dosing level for the confirmation of the RP2D in the Expansion Part for up to Cycle 28.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 13.10 • n=99 Participants
|
52.8 years
STANDARD_DEVIATION 11.86 • n=107 Participants
|
53.6 years
STANDARD_DEVIATION 11.87 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to Cycle 28 (Cycle Length= 21 days)Population: The safety analysis set included participants who received at least 1 dose of the study drug in Phase 1b.
The RP2D was the maximum tolerated dose (MTD) or less. The MTD was determined as the dose level (1, 0) at which less than or equal to (\<=) 1 of 6 evaluable participants experienced dose limiting toxicity (DLT) within the first 21 days of treatment (end of Cycle 1). Upon determination of RP2D in Cycle 1 of Phase 1b, RP2D was to be confirmed in Phase 1b-expansion Part.
Outcome measures
| Measure |
Phase 1b, All Participants
n=14 Participants
Participants received PEGPH20 3.0 mcg/kg or 1.6 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m\^2, infusion, intravenously, on Days 1 and 8 of first 21-day treatment cycle. After the determination of RP2D in Cycle 1 of Phase 1b, additional participants were enrolled for the confirmation of the RP2D in the Expansion Part for up to Cycle 28.
|
|---|---|
|
Phase 1b: Recommended Phase 2 Dose (RP2D) of Eribulin Mesylate in Combination With PEGPH20
|
NA mg/m^2
RP2D was not confirmed due to early termination of study because of poor accrual before completing Phase 1b-expansion Part (which was planned for confirming the RP2D)
|
PRIMARY outcome
Timeframe: Up to Cycle 28 (Cycle Length= 21 days)Population: The safety analysis set included participants who received at least 1 dose of the study drug in Phase 1b.
The RP2D was the MTD or less. The MTD was determined as the dose level (1, 0) at which \<=1 of 6 evaluable participants experienced DLT within the first 21 days of treatment (end of Cycle 1). Upon determination of RP2D in Cycle 1 of Phase 1b, RP2D was to be confirmed in Phase 1b-expansion Part.
Outcome measures
| Measure |
Phase 1b, All Participants
n=14 Participants
Participants received PEGPH20 3.0 mcg/kg or 1.6 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m\^2, infusion, intravenously, on Days 1 and 8 of first 21-day treatment cycle. After the determination of RP2D in Cycle 1 of Phase 1b, additional participants were enrolled for the confirmation of the RP2D in the Expansion Part for up to Cycle 28.
|
|---|---|
|
Phase 1b: Recommended Phase 2 Dose (RP2D) of PEGPH20 in Combination With Eribulin Mesylate
|
NA mcg/kg
RP2D was not confirmed due to early termination of study because of poor accrual before completing Phase 1b-expansion Part (which was planned for confirming the RP2D)
|
Adverse Events
Phase 1b: Dose Level 1
Serious events: 1 serious events
Other events: 5 other events
Deaths: 2 deaths
Phase 1b: Dose Level 0 and Expansion Part
Serious events: 3 serious events
Other events: 9 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Phase 1b: Dose Level 1
n=5 participants at risk
Participants received PEGPH20 3.0 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m\^2, infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle up to Cycle 28 (Dose level 1).
|
Phase 1b: Dose Level 0 and Expansion Part
n=9 participants at risk
Participants received PEGPH20 1.6 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m\^2, infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle for up to Cycle 28 (Dose Level 0). After the determination of RP2D at this dosing level in Cycle 1 of Phase 1b, additional participants were enrolled in this dosing level for the confirmation of the RP2D in the Expansion Part for up to Cycle 28.
|
|---|---|---|
|
General disorders
Non-cardiac chest pain
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
Other adverse events
| Measure |
Phase 1b: Dose Level 1
n=5 participants at risk
Participants received PEGPH20 3.0 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m\^2, infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle up to Cycle 28 (Dose level 1).
|
Phase 1b: Dose Level 0 and Expansion Part
n=9 participants at risk
Participants received PEGPH20 1.6 mcg/kg, infusion, intravenously on Days -1 and 7 followed by eribulin mesylate 1.4 mg/m\^2, infusion, intravenously, on Days 1 and 8 of each 21-day treatment cycle for up to Cycle 28 (Dose Level 0). After the determination of RP2D at this dosing level in Cycle 1 of Phase 1b, additional participants were enrolled in this dosing level for the confirmation of the RP2D in the Expansion Part for up to Cycle 28.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
22.2%
2/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
55.6%
5/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Eye disorders
Vision blurred
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
33.3%
3/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
22.2%
2/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Fatigue
|
60.0%
3/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
22.2%
2/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Nodule
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Oedema peripheral
|
60.0%
3/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
22.2%
2/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Pain
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
22.2%
2/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Peripheral swelling
|
40.0%
2/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Ear infection
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
Neutrophil count decreased
|
40.0%
2/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
22.2%
2/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
Weight decreased
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Investigations
White blood cell count decreased
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
22.2%
2/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.0%
2/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
33.3%
3/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
40.0%
2/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
40.0%
2/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
80.0%
4/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
44.4%
4/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
22.2%
2/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
40.0%
2/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
60.0%
3/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
66.7%
6/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
22.2%
2/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
22.2%
2/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Neuropathy peripheral
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Neurotoxicity
|
40.0%
2/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
40.0%
2/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
20.0%
1/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
0.00%
0/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
80.0%
4/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Vascular disorders
Hot flush
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
General disorders
Malaise
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/5 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
11.1%
1/9 • From the first dose of study drug up to approximately 3 years 1 month
Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place