Trial Outcomes & Findings for DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein (NCT NCT03368196)
NCT ID: NCT03368196
Last Updated: 2022-11-03
Results Overview
Adverse events (AEs) were to be coded using MedDRA Version 20.1 and assigned severity grades based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiating the study drug until 47 days after last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months post-dose
Results posted on
2022-11-03
Participant Flow
A total of 12 participants who met all inclusion criteria and no exclusion criteria were enrolled and received treatment in Taiwan.
The 6.4 mg/kg DS-8201a dose was chosen for this study based on the efficacy, safety, and pharmacokinetic profiles established in an earlier Phase 1 trial.
Participant milestones
| Measure |
DS-8201a
Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein
Baseline characteristics by cohort
| Measure |
DS-8201a
n=12 Participants
Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 8.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months post-dosePopulation: Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis Set.
Adverse events (AEs) were to be coded using MedDRA Version 20.1 and assigned severity grades based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiating the study drug until 47 days after last dose of study drug.
Outcome measures
| Measure |
DS-8201a
n=12 Participants
Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
|
|---|---|
|
Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)
Any TEAE
|
12 Participants
|
|
Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)
Any drug-related TEAE
|
12 Participants
|
|
Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)
Any TEAE of CTCAE Grade ≥3
|
7 Participants
|
|
Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)
Any drug-related TEAE of CTCAE Grade ≥3
|
6 Participants
|
|
Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)
Any serious TEAE
|
2 Participants
|
|
Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)
Any drug-related serious TEAE
|
1 Participants
|
|
Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)
Any serious TEAE of CTCAE Grade ≥3
|
2 Participants
|
|
Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)
Any drug-related serious TEAE of CTCAE Grade ≥3
|
1 Participants
|
|
Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)
Any TEAE leading to drug withdrawal
|
0 Participants
|
|
Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)
Any TEAE leading to dose reduction
|
2 Participants
|
|
Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)
Any drug-related TEAE leading to dose reduction
|
2 Participants
|
|
Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)
Any TEAE leading to dose interruption
|
5 Participants
|
|
Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)
Any drug-related TEAE leading to dose interruption
|
5 Participants
|
|
Treatment-emergent Adverse Events Following Treatment With DS-8201a (Trastuzumab Deruxtecan)
Any TEAE leading to death
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycles 1 and 3, Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4, 24 hours, 72 hours; Days 8, and 15; Cycles 2, 4, 6 and 8, Day 1: BI and EOIPopulation: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Maximum concentration (Cmax) of DS-8201a and total anti-HER2 antibody was assessed.
Outcome measures
| Measure |
DS-8201a
n=12 Participants
Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
|
|---|---|
|
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)
DS-8201a, Cycle 1
|
157 ug/mL
Standard Deviation 19.1
|
|
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)
DS-8201a, Cycle 3
|
163 ug/mL
Standard Deviation 19.5
|
|
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)
Total Anti-HER2 antibody, Cycle 1
|
150 ug/mL
Standard Deviation 22.6
|
|
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)
Total Anti-HER2 antibody, Cycle 3
|
154 ug/mL
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: Cycles 1 and 3, Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4, 24 hours, 72 hours; Days 8, and 15; Cycles 2, 4, 6 and 8, Day 1: BI and EOIPopulation: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Maximum concentration (Cmax) of MAAA-1181a was assessed.
Outcome measures
| Measure |
DS-8201a
n=12 Participants
Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
|
|---|---|
|
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) of MAAA-1181a Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)
MAAA-1181a, Cycle 1
|
11.9 ng/mL
Standard Deviation 3.79
|
|
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) of MAAA-1181a Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)
MAAA-1181a, Cycle 3
|
9.01 ng/mL
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: Cycles 1 and 3, Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4, 24 hours, 72 hours; Days 8, and 15; Cycles 2, 4, 6 and 8, Day 1: BI and EOIPopulation: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Area under the serum concentration-time curve during dosing interval (AUCtau) of DS-8201a and total anti-HER2 antibody was assessed.
Outcome measures
| Measure |
DS-8201a
n=12 Participants
Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
|
|---|---|
|
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve During Dosing Interval (AUCtau) Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)
DS-8201a, Cycle 1
|
631 ug*d/mL
Standard Deviation 173
|
|
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve During Dosing Interval (AUCtau) Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)
DS-8201a, Cycle 3
|
991 ug*d/mL
Standard Deviation 109
|
|
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve During Dosing Interval (AUCtau) Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)
Total Anti-HER2 antibody, Cycle 1
|
821 ug*d/mL
Standard Deviation 312
|
|
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve During Dosing Interval (AUCtau) Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)
Total Anti-HER2 antibody, Cycle 3
|
1180 ug*d/mL
Standard Deviation 208
|
SECONDARY outcome
Timeframe: Cycles 1 and 3, Day 1: before infusion (BI), end of infusion (EOI), 2 hours, 4 hours, 7 hours; Days 2 and 4, 24 hours, 72 hours; Days 8, and 15; Cycles 2, 4, 6 and 8, Day 1: BI and EOIPopulation: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Area under the serum concentration-time curve during dosing interval (AUCtau) of MAAA-1181a was assessed.
Outcome measures
| Measure |
DS-8201a
n=12 Participants
Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
|
|---|---|
|
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve During Dosing Interval (AUCtau) of MAAA-1181a Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)
MAAA-1181a, Cycle 1
|
36.1 ng*d/mL
Standard Deviation 9.71
|
|
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve During Dosing Interval (AUCtau) of MAAA-1181a Following Cycle 1 and Cycle 3 Treatment With DS-8201a (Trastuzumab Deruxtecan)
MAAA-1181a, Cycle 3
|
41.3 ng*d/mL
Standard Deviation 5.06
|
SECONDARY outcome
Timeframe: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months post-dosePopulation: Response was assessed in the Response Evaluable Set.
Best overall response (BOR) was assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete response (CR) was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
DS-8201a
n=11 Participants
Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
|
|---|---|
|
Best Overall Response By The Investigator's Assessment (Unconfirmed) in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer
Complete response (CR)
|
0 Participants
|
|
Best Overall Response By The Investigator's Assessment (Unconfirmed) in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer
Partial response (PR)
|
4 Participants
|
|
Best Overall Response By The Investigator's Assessment (Unconfirmed) in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer
Stable disease (SD)
|
7 Participants
|
|
Best Overall Response By The Investigator's Assessment (Unconfirmed) in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer
Non-Complete Response (CR)/Non-Progressive Disease (PD)
|
0 Participants
|
|
Best Overall Response By The Investigator's Assessment (Unconfirmed) in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer
Progressive Disease (PD)
|
0 Participants
|
|
Best Overall Response By The Investigator's Assessment (Unconfirmed) in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer
Non-evaluable (NE)
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months post-dosePopulation: Response was evaluated in the Response Evaluable Set.
Objective response rate (ORR; defined as participants who achieved CR and PR) was assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
DS-8201a
n=11 Participants
Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
|
|---|---|
|
Objective Response Rate (Unconfirmed) As Assessed in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months post-dosePopulation: Response was evaluated in the Response Evaluable Set.
Disease control rate (DCR; defined as participants who achieved CR, PR, and SD) was assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD defined as at least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
DS-8201a
n=11 Participants
Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
|
|---|---|
|
Disease Control Rate (Unconfirmed) As Assessed in Participants With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer
|
11 Participants
|
Adverse Events
DS-8201a
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DS-8201a
n=12 participants at risk
Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
Other adverse events
| Measure |
DS-8201a
n=12 participants at risk
Participants who received 6.4 mg/kg DS-8201a administered by intravenous infusion on Day 1 of each cycle, once every 3 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Eye disorders
Conjunctival haemorrhage
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Eye disorders
Dry eye
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Eye disorders
Punctate keratitis
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Eye disorders
Vision blurred
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Gastrointestinal disorders
Nausea
|
58.3%
7/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
3/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
4/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
2/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Gastrointestinal disorders
Dental caries
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Gastrointestinal disorders
Gastritis
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
General disorders
Fatigue
|
25.0%
3/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
General disorders
Influenza like illness
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
General disorders
Oedema peripheral
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Infections and infestations
Cellulitis
|
16.7%
2/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Infections and infestations
Gastroenteritis
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Infections and infestations
Tinea pedis
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Investigations
Platelet count decreased
|
58.3%
7/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
6/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Investigations
White blood cell count decreased
|
41.7%
5/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
4/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Investigations
Blood bilirubin increased
|
25.0%
3/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Investigations
Weight decreased
|
25.0%
3/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
2/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Investigations
Neutrophil count decreased
|
16.7%
2/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Investigations
Ejection fraction decreased
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Investigations
Liver function test increased
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Investigations
Lymphocyte count decreased
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
4/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
2/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protusion
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Renal and urinary disorders
Hydronephrosis
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
2/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
16.7%
2/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
8.3%
1/12 • Adverse events were assessed from baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever came first), up to approximately 5 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place