Trial · NCT03383692
Study of DS-8201a for Participants With Advanced Solid Malignant Tumors
NCT03383692, Phase 1, Completed, Daiichi Sankyo Co., Ltd.; results first posted 2021-06-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of DS-8201a for Participants With Advanced Solid Malignant Tumors. Trials, record NCT03383692. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03383692
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of DS-8201a for Participants With Advanced Solid Malignant Tumors
- NCT number
- NCT03383692
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 40 participants, actual
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Conditions
- Neoplasm Metastasis
- Interventions
- DS-8201a, Ritonavir, Itraconazole
- First posted
- 2017-12-26
- Last updated
- 2023-12-11
- Results first posted
- 2021-06-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Ritonavir - Cohort 1 | 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) | Maximum concentration (Cmax) was assessed for DS-8201a and total Anti-HER2 antibody. |
| Primary | Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) For MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1 | 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) | Maximum concentration (Cmax) was assessed for MAAA-1181a. |
| Primary | Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1 | 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) | 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. |
| Primary | Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1 | 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) | 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. |
| Primary | Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Itraconazole - Cohort 2 | 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) | Maximum concentration (Cmax) was assessed for DS-8201a and total Anti-HER2 antibody. |
| Primary | Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) of MAAA-1181a Following Treatment With DS-8201a and Itraconazole - Cohort 2 | 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) | Maximum concentration (Cmax) was assessed for MAAA-1181a. |
| Primary | Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Itraconazole - Cohort 2 | 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) | 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. |
| Primary | Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Itraconazole - Cohort 2 | 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) | 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. |
| Secondary | Best Objective Response as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors | Baseline up to disease progression, death, lost to follow up, or study discontinuation (whichever comes first), up to approximately 9 months post-dose | 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. |
| Secondary | Objective Response Ratio (ORR) as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors | Baseline up to disease progression, death, lost to follow up, or study discontinuation (whichever comes first), up to approximately 9 months post-dose | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Ritonavir - Cohort 1 | 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) | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ug/mL | MEAN |
| PRIMARY | Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) For MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1 | 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) | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ng/mL | MEAN |
| PRIMARY | Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1 | 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) | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ug*d/mL | MEAN |
| PRIMARY | Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1 | 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) | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ng*d/mL | MEAN |
| PRIMARY | Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Itraconazole - Cohort 2 | 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) | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ug/mL | MEAN |
| PRIMARY | Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) of MAAA-1181a Following Treatment With DS-8201a and Itraconazole - Cohort 2 | 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) | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ng/mL | MEAN |
| PRIMARY | Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Itraconazole - Cohort 2 | 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) | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ug*d/mL | MEAN |
| PRIMARY | Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve of MAAA-1181a Following Treatment With DS-8201a and Itraconazole - Cohort 2 | 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) | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ng*d/mL | MEAN |
| SECONDARY | Best Objective Response as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors | Baseline up to disease progression, death, lost to follow up, or study discontinuation (whichever comes first), up to approximately 9 months post-dose | Response was assessed in the Efficacy Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Ratio (ORR) as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors | Baseline up to disease progression, death, lost to follow up, or study discontinuation (whichever comes first), up to approximately 9 months post-dose | Response was assessed in the Efficacy Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Ritonavir - Cohort 1 | Cohort 1: DS-8201a + Ritonavir | DS-8201a, Cycle 2: DS-8201a only | 133 | Standard Deviation 25.5 | ug/mL |
| Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Ritonavir - Cohort 1 | Cohort 1: DS-8201a + Ritonavir | DS-8201a, Cycle 3: DS-8201a + ritonavir | 140 | Standard Deviation 23.0 | ug/mL |
| Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Ritonavir - Cohort 1 | Cohort 1: DS-8201a + Ritonavir | Total Anti-HER2 antibody, Cycle 2: DS-8201a only | 121 | Standard Deviation 22.2 | ug/mL |
| Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) Following Treatment With DS-8201a and Ritonavir - Cohort 1 | Cohort 1: DS-8201a + Ritonavir | Total Anti-HER2 antibody, Cycle 3: DS-8201a + ritonavir | 126 | Standard Deviation 23.1 | ug/mL |
| Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) For MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1 | Cohort 1: DS-8201a + Ritonavir | MAAA-1181a, Cycle 2: DS-8201a only | 8.98 | Standard Deviation 2.83 | ng/mL |
| Pharmacokinetic Parameter of Maximum (Peak) Observed Serum Concentration (Cmax) For MAAA-1181a Following Treatment With DS-8201a and Ritonavir - Cohort 1 | Cohort 1: DS-8201a + Ritonavir | MAAA-1181a, Cycle 3: DS-8201a + ritonavir | 8.95 | Standard Deviation 3.68 | ng/mL |
| Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1 | Cohort 1: DS-8201a + Ritonavir | DS-8201a, Cycle 2 (DS-8201a only): AUC17d | 650 | Standard Deviation 168.0 | ug*d/mL |
| Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1 | Cohort 1: DS-8201a + Ritonavir | DS-8201a, Cycle 2 (DS-8201a only): AUCtau | 701 | Standard Deviation 185 | ug*d/mL |
| Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1 | Cohort 1: DS-8201a + Ritonavir | DS-8201a, Cycle 3 (DS-8201a + ritonavir): AUC17d | 754 | Standard Deviation 137.0 | ug*d/mL |
| Pharmacokinetic Parameter of Area Under the Serum Concentration-time Curve Following Treatment With DS-8201a and Ritonavir - Cohort 1 | Cohort 1: DS-8201a + Ritonavir | DS-8201a, Cycle 3 (DS-8201a + ritonavir): AUCtau | 810 | Standard Deviation 153.0 | ug*d/mL |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: DS-8201a + Ritonavir | 17 | |
| Overall Study | STARTED | Cohort 2: DS-8201a + Itraconazole | 23 | |
| Overall Study | COMPLETED | Cohort 1: DS-8201a + Ritonavir | 11 | |
| Overall Study | COMPLETED | Cohort 2: DS-8201a + Itraconazole | 19 | |
| Overall Study | NOT COMPLETED | Cohort 1: DS-8201a + Ritonavir | 6 | |
| Overall Study | NOT COMPLETED | Cohort 2: DS-8201a + Itraconazole | 4 |
Source ClinicalTrials.gov
Adverse events184
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Cohort 1: DS-8201a + Ritonavir | 3 | 17 | |
| other | Nasopharyngitis | Infections and infestations | Cohort 2: DS-8201a + Itraconazole | 0 | 23 | |
| other | Paroncyhia | Infections and infestations | Cohort 1: DS-8201a + Ritonavir | 1 | 17 | |
| other | Paroncyhia | Infections and infestations | Cohort 2: DS-8201a + Itraconazole | 1 | 23 | |
| other | Cystitis | Infections and infestations | Cohort 1: DS-8201a + Ritonavir | 1 | 17 | |
| other | Cystitis | Infections and infestations | Cohort 2: DS-8201a + Itraconazole | 0 | 23 | |
| other | Infected dermal cyst | Infections and infestations | Cohort 1: DS-8201a + Ritonavir | 1 | 17 | |
| other | Infected dermal cyst | Infections and infestations | Cohort 2: DS-8201a + Itraconazole | 0 | 23 | |
| other | Influenza | Infections and infestations | Cohort 1: DS-8201a + Ritonavir | 1 | 17 | |
| other | Influenza | Infections and infestations | Cohort 2: DS-8201a + Itraconazole | 0 | 23 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: DS-8201a + Ritonavir | 1 | 17 |
| Total, all-cause mortality | Cohort 2: DS-8201a + Itraconazole | 0 | 23 |
| Total, other adverse events | Cohort 1: DS-8201a + Ritonavir | 17 | 17 |
| Total, other adverse events | Cohort 2: DS-8201a + Itraconazole | 22 | 23 |
| Total, serious adverse events | Cohort 1: DS-8201a + Ritonavir | 2 | 17 |
| Total, serious adverse events | Cohort 2: DS-8201a + Itraconazole | 3 | 23 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38231777 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Cohort 1: DS-8201a + Ritonavir vs Cohort 2: DS-8201a + Itraconazole: Objective Response Rate as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors | Trial comparisons |
Cohort 1: DS-8201a + Ritonavir vs Cohort 2: DS-8201a + Itraconazole: Objective Response Ratio (ORR) as Confirmed By The Investigator's Assessment in Participants With HER2-Expressing Advanced Solid Malignant Tumors | Trial comparisons |
| Cohort 1: DS-8201a + Ritonavir vs Cohort 2: DS-8201a + Itraconazole: deaths from any cause | Trial comparisons |
| Cohort 1: DS-8201a + Ritonavir vs Cohort 2: DS-8201a + Itraconazole: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03383692
GET https://conductscience.org/api/trials/v1/NCT03383692/results?page=2