Trial · NCT02564900
Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
NCT02564900, Phase 1, Completed, Daiichi Sankyo Co., Ltd.; results first posted 2021-06-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors. Trials, record NCT02564900. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02564900
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
- NCT number
- NCT02564900
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 292 participants, actual
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Conditions
- Advanced Solid Tumors
- Interventions
- DS-8201a (DP1), DS-8201a (DP2), DS-8201a (DP)
- First posted
- 2015-10-01
- Last updated
- 2024-01-22
- Results first posted
- 2021-06-23
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | From 6 months postdose of last participant up to 3 years 5 months | Objective response rate (ORR) by independent central review was defined as the proportion of participants who achieve either complete response \[CR\] or partial response \[PR\] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 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. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer. |
| Secondary | Disease Control Rate (DCR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | From 6 months postdose of last participant up to 3 years 5 months | Disease control rate (DCR) by independent central review was calculated as the proportion of participants demonstrating complete response (CR), partial response (PR), or stable disease (SD) for a minimum of 6 weeks (±1week) from the first dosing date. CR was defined as a disappearance of all target lesions, PR 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. HER2-positive other solid tumors included 8 participants with salivary/submandibular/parotid gland, 2 breast with HER2-mutation, 2 endometrial, 2 esophageal, 2 Paget's disease, 1 cholangiocarcinoma, 1 extraskeletal myxoide chondrosarcoma, 1 gallbladder, 1 pancreatic, 1 small intestine, 1 uterine cervix, and 1 participant who received 5.4 mg/kg with HER2-low gastric/GEJ cancer. |
| Secondary | Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | From 6 months postdose of last participant up to 3 years 5 months | Best overall response by independent central review was defined as the proportion of participants who achieved either complete response \[CR\], partial response \[PR\], stable disease (SD), progressive disease (PD), or were non-evaluable (NE) as per RECIST v1.1. CR was defined as a disappearance of all target lesions, PR at least a 30% decrease in the sum of diameters of target lesions, and SD 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. HER2-positive other solid tumors included 8 participants with salivary/submandibular/parotid gland, 2 breast with HER2-mutation, 2 endometrial, 2 esophageal, 2 Paget's disease, 1 cholangiocarcinoma, 1 extraskeletal myxoide chondrosarcoma, 1 gallbladder, 1 pancreatic, 1 small intestine, 1 uterine cervix, and 1 participant who received 5.4 mg/kg with HER2-low gastric/GEJ cancer. |
| Secondary | Duration of Response (DoR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) | From 6 months postdose of last participant up to 3 years 5 months | Duration of response (DoR) by independent central review was defined as the time between the date of the first complete response (CR) or partial response (PR) until the date of the first documentation of progressive disease (PD) or death due to any cause. CR was defined as a disappearance of all target lesions, PR as at least a 30% decrease in the sum of diameters of target lesions, and PD as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer. |
| Secondary | Time to Response (TTR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) | From 6 months postdose of last participant up to 3 years 5 months | Time to response (TTR) by independent central review was defined as the time interval between the date of registration until the date at which the criteria were first met for complete response (CR) or partial response (PR). Only participants who achieved CR or PR were included in the TTR analysis. 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. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer. |
| Secondary | Progression-free Survival Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) | From 6 months postdose of last participant up to 3 years 5 months | Progression-free survival (PFS) by independent central review was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer. |
| Secondary | Overall Survival Among Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) | From 6 months postdose of last participant up to 3 years 5 months | Overall survival (OS) by independent central review was defined as the time interval from the date of enrollment to the date of death from any cause. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer. |
| Secondary | Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum DS-8201a Following First Dose | Post first dose up to Day 147 | The serum PK parameters of DS-8201a and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods. |
| Secondary | Pharmacokinetic Analysis: Maximum (Peak) Observed Serum Concentration (Cmax) of Serum DS-8201a Following First Dose | Post first dose up to Day 147 | The serum PK parameters Maximum (peak) Observed serum concentration of DS-8201a and its analytes were estimated using standard non-compartmental method. |
| Secondary | Pharmacokinetic Analysis: Time of Maximum Plasma Concentration (Tmax) of Serum DS-8201a Following First Dose | Post first dose up to Day 147 | The serum PK parameters of Time of maximum plasma concentration (Tmax) for DS-8201a and its analytes were estimated using standard non-compartmental methods. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | From 6 months postdose of last participant up to 3 years 5 months | ORR was assessed among participants in the Intent-to-Treat Analysis Set. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | From 6 months postdose of last participant up to 3 years 5 months | DCR was assessed in the Intent-to-Treat Analysis Set. | percentage of participants | NUMBER |
| SECONDARY | Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | From 6 months postdose of last participant up to 3 years 5 months | Best overall response was assessed in the Intent-to-Treat Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DoR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) | From 6 months postdose of last participant up to 3 years 5 months | DoR was assessed among participants who achieved a CR or PR in the Intent-to-Treat Analysis Set. | months | MEDIAN |
| SECONDARY | Time to Response (TTR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) | From 6 months postdose of last participant up to 3 years 5 months | Time to response was assessed among participants who achieved CR or PR in the Intent-to-Treat Analysis Set. | months | MEDIAN |
| SECONDARY | Progression-free Survival Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) | From 6 months postdose of last participant up to 3 years 5 months | PFS was assessed in the Intent-to-Treat Analysis Set. | months | MEDIAN |
| SECONDARY | Overall Survival Among Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases) | From 6 months postdose of last participant up to 3 years 5 months | OS was assessed in the Intent-to-Treat Analysis Set. | months | MEDIAN |
| SECONDARY | Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum DS-8201a Following First Dose | Post first dose up to Day 147 | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ug*d/mL | MEAN |
| SECONDARY | Pharmacokinetic Analysis: Maximum (Peak) Observed Serum Concentration (Cmax) of Serum DS-8201a Following First Dose | Post first dose up to Day 147 | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ug/mL | MEAN |
| SECONDARY | Pharmacokinetic Analysis: Time of Maximum Plasma Concentration (Tmax) of Serum DS-8201a Following First Dose | Post first dose up to Day 147 | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | hours | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group393
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | 95% Confidence Interval 0 to 70.8 | percentage of participants | |
| Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | Dose Escalation: Cohort 2, 1.6 mg/kg | 33.3 | 95% Confidence Interval 0.8 to 90.6 | percentage of participants | |
| Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | 95% Confidence Interval 0 to 70.8 | percentage of participants | |
| Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | Dose Escalation: Cohort 4, 5.4 mg/kg | 83.3 | 95% Confidence Interval 35.9 to 99.6 | percentage of participants | |
| Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | Dose Escalation: Cohort 5, 6.4 mg/kg | 33.3 | 95% Confidence Interval 4.3 to 77.7 | percentage of participants | |
| Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | Dose Escalation: Cohort 6, 8.0 mg/kg | 50.0 | 95% Confidence Interval 11.8 to 88.2 | percentage of participants | |
| Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 51.0 | 95% Confidence Interval 36.6 to 65.2 | percentage of participants | |
| Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 53.7 | 95% Confidence Interval 41.1 to 66.0 | percentage of participants | |
| Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 33.3 | 95% Confidence Interval 14.6 to 57.0 | percentage of participants | |
| Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases) | Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 39.4 | 95% Confidence Interval 22.9 to 57.9 | percentage of participants |
1 to 10 of 393Source ClinicalTrials.gov
See all 393 results by groupParticipant flow105
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation | STARTED | Dose Escalation: Cohort 1, 0.8 mg/kg | 3 | |
| Dose Escalation | STARTED | Dose Escalation: Cohort 2, 1.6 mg/kg | 3 | |
| Dose Escalation | STARTED | Dose Escalation: Cohort 3, 3.2 mg/kg | 3 | |
| Dose Escalation | STARTED | Dose Escalation: Cohort 4, 5.4 mg/kg | 6 | |
| Dose Escalation | STARTED | Dose Escalation: Cohort 5, 6.4 mg/kg | 6 | |
| Dose Escalation | STARTED | Dose Escalation: Cohort 6, 8.0 mg/kg | 6 | |
| Dose Escalation | STARTED | Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 0 | |
| Dose Escalation | STARTED | Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 0 | |
| Dose Escalation | STARTED | Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 0 | |
| Dose Escalation | STARTED | Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 0 |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 participant flowAdverse events3,094
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 | Dose Escalation: Cohort 1, 0.8 mg/kg | 1 | 3 | |
| other | Nasopharyngitis | Infections and infestations | Dose Escalation: Cohort 2, 1.6 mg/kg | 1 | 3 | |
| other | Nasopharyngitis | Infections and infestations | Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | 3 | |
| other | Nasopharyngitis | Infections and infestations | Dose Escalation: Cohort 4, 5.4 mg/kg | 2 | 6 | |
| other | Nasopharyngitis | Infections and infestations | Dose Escalation: Cohort 5, 6.4 mg/kg | 0 | 6 | |
| other | Nasopharyngitis | Infections and infestations | Dose Escalation: Cohort 6, 8.0 mg/kg | 0 | 6 | |
| other | Nasopharyngitis | Infections and infestations | Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 5 | 50 | |
| other | Nasopharyngitis | Infections and infestations | Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 9 | 66 | |
| other | Nasopharyngitis | Infections and infestations | Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 0 | 21 | |
| other | Nasopharyngitis | Infections and infestations | Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 4 | 33 |
1 to 10 of 3,094Source ClinicalTrials.gov
See all 3,094 adverse eventsAdverse event totals39
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | 3 |
| Total, all-cause mortality | Dose Escalation: Cohort 2, 1.6 mg/kg | 0 | 3 |
| Total, all-cause mortality | Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | 3 |
| Total, all-cause mortality | Dose Escalation: Cohort 4, 5.4 mg/kg | 0 | 6 |
| Total, all-cause mortality | Dose Escalation: Cohort 5, 6.4 mg/kg | 0 | 6 |
| Total, all-cause mortality | Dose Escalation: Cohort 6, 8.0 mg/kg | 0 | 6 |
| Total, all-cause mortality | Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 3 | 50 |
| Total, all-cause mortality | Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 1 | 66 |
| Total, all-cause mortality | Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 0 | 21 |
| Total, all-cause mortality | Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 0 | 33 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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