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Trial Outcomes & Findings for Study of DS-8201a for Participants With Advanced Solid Malignant Tumors (NCT NCT03383692)

NCT ID: NCT03383692

Last Updated: 2023-12-11

Results Overview

Maximum concentration (Cmax) was assessed for DS-8201a and total Anti-HER2 antibody.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

40 participants

Primary outcome timeframe

Cycle 1: Day 1, pre-dose and end of infusion (EOI); Cycles 2 and 3: Day 1, pre-dose, EOI, 2 hours, 4 hours, 7 hours; Day 2, 4, 8, 12, 17, and 22; Cycles 4, 6 and 8: Day 1, pre-dose and EOI (each cycle is 22 days)

Results posted on

2023-12-11

Participant Flow

A total of 40 participants who met all inclusion criteria and no exclusion criteria were enrolled and received treatment at 10 study centers in Japan, South Korea, and Taiwan.

Based on the pharmacokinetic parameters of DS-8201a assessed in an earlier Phase 1 trial, 5.4 mg/kg DS-8201a was chosen to assess drug interactions.

Participant milestones

Participant milestones
Measure
Cohort 1: DS-8201a + Ritonavir
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
Overall Study
STARTED
17
23
Overall Study
COMPLETED
11
19
Overall Study
NOT COMPLETED
6
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Cohort 1: DS-8201a + Ritonavir
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
Overall Study
Progressive disease as per RECIST
3
3
Overall Study
Clinical progression
0
1
Overall Study
Adverse Event
3
0

Baseline Characteristics

Study of DS-8201a for Participants With Advanced Solid Malignant Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort 1: DS-8201a + Ritonavir
n=17 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
n=23 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole BID on Day 17 of Cycle 2 followed by 200 mg QD until Day 21 of Cycle 3.
Total
n=40 Participants
Total of all reporting groups
Age, Continuous
60.5 years
STANDARD_DEVIATION 9.45 • n=99 Participants
53.5 years
STANDARD_DEVIATION 12.91 • n=107 Participants
56.5 years
STANDARD_DEVIATION 11.96 • n=206 Participants
Age, Customized
<65 years
10 Participants
n=99 Participants
18 Participants
n=107 Participants
28 Participants
n=206 Participants
Age, Customized
≥65 years
7 Participants
n=99 Participants
5 Participants
n=107 Participants
12 Participants
n=206 Participants
Sex: Female, Male
Female
12 Participants
n=99 Participants
10 Participants
n=107 Participants
22 Participants
n=206 Participants
Sex: Female, Male
Male
5 Participants
n=99 Participants
13 Participants
n=107 Participants
18 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
17 Participants
n=99 Participants
23 Participants
n=107 Participants
40 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
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
White
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 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
0 Participants
n=107 Participants
0 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Cycle 1: Day 1, pre-dose and end of infusion (EOI); Cycles 2 and 3: Day 1, pre-dose, EOI, 2 hours, 4 hours, 7 hours; Day 2, 4, 8, 12, 17, and 22; Cycles 4, 6 and 8: Day 1, pre-dose and EOI (each cycle is 22 days)

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Maximum concentration (Cmax) was assessed for DS-8201a and total Anti-HER2 antibody.

Outcome measures

Outcome measures
Measure
Cohort 1: DS-8201a + Ritonavir
n=12 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Ritonavir - Cohort 1
DS-8201a, Cycle 2: DS-8201a only
133 ug/mL
Standard Deviation 25.5
—
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Ritonavir - Cohort 1
DS-8201a, Cycle 3: DS-8201a + ritonavir
140 ug/mL
Standard Deviation 23.0
—
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Ritonavir - Cohort 1
Total Anti-HER2 antibody, Cycle 2: DS-8201a only
121 ug/mL
Standard Deviation 22.2
—
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Ritonavir - Cohort 1
Total Anti-HER2 antibody, Cycle 3: DS-8201a + ritonavir
126 ug/mL
Standard Deviation 23.1
—

PRIMARY outcome

Timeframe: Cycle 1: Day 1, pre-dose and end of infusion (EOI); Cycles 2 and 3: Day 1, pre-dose, EOI, 2 hours, 4 hours, 7 hours; Day 2, 4, 8, 12, 17, and 22; Cycles 4, 6 and 8: Day 1, pre-dose and EOI (each cycle is 22 days)

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Maximum concentration (Cmax) was assessed for MAAA-1181a.

Outcome measures

Outcome measures
Measure
Cohort 1: DS-8201a + Ritonavir
n=12 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) For MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1
MAAA-1181a, Cycle 2: DS-8201a only
8.98 ng/mL
Standard Deviation 2.83
—
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) For MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1
MAAA-1181a, Cycle 3: DS-8201a + ritonavir
8.95 ng/mL
Standard Deviation 3.68
—

PRIMARY outcome

Timeframe: Cycle 1: Day 1, pre-dose and end of infusion (EOI); Cycles 2 and 3: Day 1, pre-dose, EOI, 2 hours, 4 hours, 7 hours; Day 2, 4, 8, 12, 17, and 22; Cycles 4, 6 and 8: Day 1, pre-dose and EOI (each cycle is 22 days)

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Area under the serum concentration-time curve from time zero to 17 days (AUC17d) and during the dosing interval (AUCtau) for DS-8201a and total anti-HER2 antibody were assessed.

Outcome measures

Outcome measures
Measure
Cohort 1: DS-8201a + Ritonavir
n=12 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1
DS-8201a, Cycle 2 (DS-8201a only): AUC17d
650 ug*d/mL
Standard Deviation 168.0
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1
DS-8201a, Cycle 2 (DS-8201a only): AUCtau
701 ug*d/mL
Standard Deviation 185
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1
DS-8201a, Cycle 3 (DS-8201a + ritonavir): AUC17d
754 ug*d/mL
Standard Deviation 137.0
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1
DS-8201a, Cycle 3 (DS-8201a + ritonavir): AUCtau
810 ug*d/mL
Standard Deviation 153.0
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1
Total Anti-HER2 antibody, Cycle 2 (DS-8201a only): AUC17d
723 ug*d/mL
Standard Deviation 191
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1
Total Anti-HER2 antibody, Cycle 2 (DS-8201a only): AUCtau
791 ug*d/mL
Standard Deviation 217
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1
Total Anti-HER2 antibody, Cycle 3 (DS-8201a + ritonavir): AUC17d
796 ug*d/mL
Standard Deviation 155
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1
Total Anti-HER2 antibody, Cycle 3 (DS-8201a + ritonavir): AUCtau
860 ug*d/mL
Standard Deviation 170
—

PRIMARY outcome

Timeframe: Cycle 1: Day 1, pre-dose and end of infusion (EOI); Cycles 2 and 3: Day 1, pre-dose, EOI, 2 hours, 4 hours, 7 hours; Day 2, 4, 8, 12, 17, and 22; Cycles 4, 6 and 8: Day 1, pre-dose and EOI (each cycle is 22 days)

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Area under the serum concentration-time curve from time zero to 17 days (AUC17d) and during the dosing interval (AUCtau) were assessed for MAAA-1181a.

Outcome measures

Outcome measures
Measure
Cohort 1: DS-8201a + Ritonavir
n=12 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1
MAAA-1181a, Cycle 3 (DS-8201a + ritonavir): AUC17d
37.2 ng*d/mL
Standard Deviation 6.93
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1
MAAA-1181a, Cycle 3 (DS-8201a + ritonavir): AUCtau
39.2 ng*d/mL
Standard Deviation 7.98
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1
MAAA-1181a, Cycle 2 (DS-8201a only): AUC17d
32.7 ng*d/mL
Standard Deviation 7.45
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1
MAAA-1181a, Cycle 2 (DS-8201a only): AUCtau
35.0 ng*d/mL
Standard Deviation 8.10
—

PRIMARY outcome

Timeframe: Cycle 1: Day 1, pre-dose and end of infusion (EOI); Cycles 2 and 3: Day 1, pre-dose, EOI, 2 hours, 4 hours, 7 hours; Day 2, 4, 8, 12, 17, and 22; Cycles 4, 6 and 8: Day 1, pre-dose and EOI (each cycle is 22 days)

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Maximum concentration (Cmax) was assessed for DS-8201a and total Anti-HER2 antibody.

Outcome measures

Outcome measures
Measure
Cohort 1: DS-8201a + Ritonavir
n=14 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Itraconazole - Cohort 2
DS-8201a, Cycle 2: DS-8201a only
139 ug/mL
Standard Deviation 23.6
—
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Itraconazole - Cohort 2
DS-8201a, Cycle 3: DS-8201a + ritonavir
142 ug/mL
Standard Deviation 23.9
—
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Itraconazole - Cohort 2
Total Anti-HER2 antibody, Cycle 2: DS-8201a only
119 ug/mL
Standard Deviation 19.1
—
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Itraconazole - Cohort 2
Total Anti-HER2 antibody, Cycle 3: DS-8201a + ritonavir
130 ug/mL
Standard Deviation 18.2
—

PRIMARY outcome

Timeframe: Cycle 1: Day 1, pre-dose and end of infusion (EOI); Cycles 2 and 3: Day 1, pre-dose, EOI, 2 hours, 4 hours, 7 hours; Day 2, 4, 8, 12, 17, and 22; Cycles 4, 6 and 8: Day 1, pre-dose and EOI (each cycle is 22 days)

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Maximum concentration (Cmax) was assessed for MAAA-1181a.

Outcome measures

Outcome measures
Measure
Cohort 1: DS-8201a + Ritonavir
n=14 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) of MAAA-1181a Following Treatment With DS-8201a and Itraconazole - Cohort 2
MAAA-1181a, Cycle 2: DS-8201a only
8.65 ng/mL
Standard Deviation 2.03
—
Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) of MAAA-1181a Following Treatment With DS-8201a and Itraconazole - Cohort 2
MAAA-1181a, Cycle 3: DS-8201a + ritonavir
8.93 ng/mL
Standard Deviation 1.77
—

PRIMARY outcome

Timeframe: Cycle 1: Day 1, pre-dose and end of infusion (EOI); Cycles 2 and 3: Day 1, pre-dose, EOI, 2 hours, 4 hours, 7 hours; Day 2, 4, 8, 12, 17, and 22; Cycles 4, 6 and 8: Day 1, pre-dose and EOI (each cycle is 22 days)

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Area under the serum concentration-time curve from time zero to 17 days (AUC17d) and during the dosing interval (AUCtau) were assessed for DS-8201a and total anti-HER2 antibody.

Outcome measures

Outcome measures
Measure
Cohort 1: DS-8201a + Ritonavir
n=14 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Itraconazole - Cohort 2
Total Anti-HER2 antibody, Cycle 3 (DS-8201a + ritonavir): AUCtau
883 ug*d/mL
Standard Deviation 238
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Itraconazole - Cohort 2
DS-8201a, Cycle 2 (DS-8201a only): AUC17d
644 ug*d/mL
Standard Deviation 188
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Itraconazole - Cohort 2
DS-8201a, Cycle 2 (DS-8201a only): AUCtau
706 ug*d/mL
Standard Deviation 211
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Itraconazole - Cohort 2
DS-8201a, Cycle 3 (DS-8201a + ritonavir): AUC17d
710 ug*d/mL
Standard Deviation 187
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Itraconazole - Cohort 2
DS-8201a, Cycle 3 (DS-8201a + ritonavir): AUCtau
789 ug*d/mL
Standard Deviation 217
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Itraconazole - Cohort 2
Total Anti-HER2 antibody, Cycle 2 (DS-8201a only): AUC17d
707 ug*d/mL
Standard Deviation 194
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Itraconazole - Cohort 2
Total Anti-HER2 antibody, Cycle 2 (DS-8201a only): AUCtau
790 ug*d/mL
Standard Deviation 224
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Itraconazole - Cohort 2
Total Anti-HER2 antibody, Cycle 3 (DS-8201a + ritonavir): AUC17d
781 ug*d/mL
Standard Deviation 196
—

PRIMARY outcome

Timeframe: Cycle 1: Day 1, pre-dose and end of infusion (EOI); Cycles 2 and 3: Day 1, pre-dose, EOI, 2 hours, 4 hours, 7 hours; Day 2, 4, 8, 12, 17, and 22; Cycles 4, 6 and 8: Day 1, pre-dose and EOI (each cycle is 22 days)

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Area under the serum concentration-time curve from time zero to 17 days (AUC17d) and during the dosing interval (AUCtau) were assessed for MAAA-1181a.

Outcome measures

Outcome measures
Measure
Cohort 1: DS-8201a + Ritonavir
n=14 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Itraconazole - Cohort 2
MAAA-1181a, Cycle 2 (DS-8201a only): AUC17d
29.9 ng*d/mL
Standard Deviation 8.31
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Itraconazole - Cohort 2
MAAA-1181a, Cycle 2 (DS-8201a only): AUCtau
32.4 ng*d/mL
Standard Deviation 9.21
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Itraconazole - Cohort 2
MAAA-1181a, Cycle 3 (DS-8201a + ritonavir): AUC17d
34.8 ng*d/mL
Standard Deviation 8.04
—
Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Itraconazole - Cohort 2
MAAA-1181a, Cycle 3 (DS-8201a + ritonavir): AUCtau
37.7 ng*d/mL
Standard Deviation 8.87
—

SECONDARY outcome

Timeframe: Baseline up to disease progression, death, lost to follow up, or study discontinuation (whichever comes first), up to approximately 9 months post-dose

Population: Response was assessed in the Efficacy Analysis Set.

Best objective response (BOR) was assessed by the investigator based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Completed 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

Outcome measures
Measure
Cohort 1: DS-8201a + Ritonavir
n=17 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
n=19 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
Best Objective Response as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors
Partial response (PR)
9 Participants
10 Participants
Best Objective Response as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors
Stable disease (SD)
8 Participants
8 Participants
Best Objective Response as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors
Non-CR/Non-PR
0 Participants
0 Participants
Best Objective Response as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors
Progressive disease (PD)
0 Participants
1 Participants
Best Objective Response as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors
Non evaluable
0 Participants
0 Participants
Best Objective Response as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors
Complete response (CR)
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Baseline up to disease progression, death, lost to follow up, or study discontinuation (whichever comes first), up to approximately 9 months post-dose

Population: Response was assessed in the Efficacy Analysis Set.

Objective response ratio (ORR) was defined as the proportion of participants who achieved CR and PR as 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

Outcome measures
Measure
Cohort 1: DS-8201a + Ritonavir
n=17 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
n=19 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
Objective Response Ratio (ORR) as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors
9 Participants
10 Participants

SECONDARY outcome

Timeframe: Baseline up to disease progression, death, lost to follow up, or study discontinuation (whichever comes first), up to approximately 9 months post-dose

Population: Response was assessed in the Efficacy Analysis Set.

Objective response rate (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. ORR with confirmation is Objective Response Rate applying a confirmed response of CR/PR in RECIST version 1.1.

Outcome measures

Outcome measures
Measure
Cohort 1: DS-8201a + Ritonavir
n=17 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
n=19 Participants
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole twice daily (BID) on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3.
Objective Response Rate as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors
8 Participants
7 Participants

Adverse Events

Cohort 1: DS-8201a + Ritonavir

Serious events: 2 serious events
Other events: 17 other events
Deaths: 1 deaths

Cohort 2: DS-8201a + Itraconazole

Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Cohort 1: DS-8201a + Ritonavir
n=17 participants at risk
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
n=23 participants at risk
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole BID on Day 17 of Cycle 2 followed by 200 mg QD until Day 21 of Cycle 3.
General disorders
Disease progression
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
General disorders
Pyrexia
0.00%
0/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Gastrointestinal disorders
Diarrhoea
0.00%
0/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Gastrointestinal disorders
Ileus
0.00%
0/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Gastrointestinal disorders
Nausea
0.00%
0/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Gastrointestinal disorders
Vomiting
0.00%
0/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Infections and infestations
Sepsis
0.00%
0/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.

Other adverse events

Other adverse events
Measure
Cohort 1: DS-8201a + Ritonavir
n=17 participants at risk
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily on Day 17 of Cycle 2 until Day 21 of Cycle 3.
Cohort 2: DS-8201a + Itraconazole
n=23 participants at risk
Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole BID on Day 17 of Cycle 2 followed by 200 mg QD until Day 21 of Cycle 3.
Infections and infestations
Nasopharyngitis
17.6%
3/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Infections and infestations
Paroncyhia
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Infections and infestations
Cystitis
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Infections and infestations
Infected dermal cyst
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Infections and infestations
Influenza
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Infections and infestations
Osteomyelitis
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Infections and infestations
Upper respiratory tract infection
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Infections and infestations
Vulvovaginal candidiasis
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Blood and lymphatic system disorders
Anaemia
35.3%
6/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
21.7%
5/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Blood and lymphatic system disorders
Neutropenia
29.4%
5/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Blood and lymphatic system disorders
Thrombocytopenia
23.5%
4/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Blood and lymphatic system disorders
Leukopenia
11.8%
2/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Blood and lymphatic system disorders
Lymphopenia
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Metabolism and nutrition disorders
Decreased appetite
76.5%
13/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
39.1%
9/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Metabolism and nutrition disorders
Hypoalbuminaemia
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Metabolism and nutrition disorders
Hypokalaemia
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Nervous system disorders
Headache
23.5%
4/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
8.7%
2/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Nervous system disorders
Dysgeusia
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Nervous system disorders
Akathisia
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Nervous system disorders
Hyperaesthesia
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Nervous system disorders
Neuropathy peripheral
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Nervous system disorders
Peripheral sensory neuropathy
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Nervous system disorders
Somnolence
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Eye disorders
Eye discharge
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Cardiac disorders
Atrioventricular block first degree
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Cardiac disorders
Palpitations
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Vascular disorders
Hot flush
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Respiratory, thoracic and mediastinal disorders
Cough
11.8%
2/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
17.4%
4/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Respiratory, thoracic and mediastinal disorders
Hypoxia
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Gastrointestinal disorders
Nausea
100.0%
17/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
65.2%
15/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Gastrointestinal disorders
Constipation
47.1%
8/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
30.4%
7/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Gastrointestinal disorders
Diarrhoea
47.1%
8/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
21.7%
5/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Gastrointestinal disorders
Vomiting
17.6%
3/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
34.8%
8/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Gastrointestinal disorders
Stomatitis
23.5%
4/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
8.7%
2/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Gastrointestinal disorders
Haemorrhoids
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Gastrointestinal disorders
Ileus
0.00%
0/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
8.7%
2/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Gastrointestinal disorders
Abdominal discomfort
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Gastrointestinal disorders
Abdominal pain
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Gastrointestinal disorders
Abdominal pain upper
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Gastrointestinal disorders
Mouth haemorrhage
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Hepatobiliary disorders
Hepatic function abnormal
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Skin and subcutaneous tissue disorders
Alopecia
35.3%
6/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
30.4%
7/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Skin and subcutaneous tissue disorders
Rash
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
8.7%
2/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Skin and subcutaneous tissue disorders
Dry skin
11.8%
2/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Skin and subcutaneous tissue disorders
Rash maculo-papular
11.8%
2/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Skin and subcutaneous tissue disorders
Night sweats
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Skin and subcutaneous tissue disorders
Rash erythematous
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
11.8%
2/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Musculoskeletal and connective tissue disorders
Arthralgia
11.8%
2/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
8.7%
2/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Musculoskeletal and connective tissue disorders
Myalgia
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Renal and urinary disorders
Dysuria
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Renal and urinary disorders
Renal impairment
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Reproductive system and breast disorders
Atrophic vulvovaginitis
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
General disorders
Fatigue
29.4%
5/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
17.4%
4/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
General disorders
Malaise
23.5%
4/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
General disorders
Pyrexia
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
General disorders
Disease progression
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
General disorders
Oedema peripheral
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
General disorders
Peripheral swelling
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
Neutrophil count decreased
35.3%
6/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
34.8%
8/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
White blood cell count decreased
41.2%
7/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
30.4%
7/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
Platelet count decreased
52.9%
9/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
17.4%
4/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
Aspartate aminotransferase increased
35.3%
6/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
21.7%
5/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
Alanine aminotransferase increased
41.2%
7/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
13.0%
3/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
Blood alkaline phosphatase increased
23.5%
4/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
Weight decreased
11.8%
2/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
8.7%
2/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
Blood creatinine increased
11.8%
2/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
Troponin I increased
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
4.3%
1/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
Alanine aminotransferase decreased
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
Aspartate aminotransferase decreased
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
Blood bilirubin increased
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
Blood lactate dehydrogenase increased
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
Gamma-glutamyltransferase increased
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
Ophthalmological examination abnormal
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
Investigations
Protein total decreased
5.9%
1/17 • Adverse event data were collected from baseline up to approximately 9 months post-dose.
0.00%
0/23 • Adverse event data were collected from baseline up to approximately 9 months post-dose.

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 908-992-6400

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place