TriangleNCT02564900 · OUTCOME
Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From 6 months postdose of last participant up to 3 years 5 months
What was measured
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.
Analysis population: ORR was assessed among participants in the Intent-to-Treat Analysis Set.
Groups in this outcome
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 2, 1.6 mg/kg
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-expressing NSCLC Tumors
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-expressing Colorectal Tumors
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
| Group | Source count |
|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 3 |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 3 |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 3 |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 6 |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 6 |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 6 |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 51 |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 67 |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 21 |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 33 |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 19 |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 25 |
| Dose Expansion: HER2-expressing NSCLC Tumors | 18 |
| Dose Expansion: HER2-expressing Colorectal Tumors | 20 |
| Dose Expansion: HER2-expressing Other Solid Tumors | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 0 | Not reported | 0 | 70.8 | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 33.3 | Not reported | 0.8 | 90.6 | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 0 | Not reported | 0 | 70.8 | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 83.3 | Not reported | 35.9 | 99.6 | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 33.3 | Not reported | 4.3 | 77.7 | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 50.0 | Not reported | 11.8 | 88.2 | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 51.0 | Not reported | 36.6 | 65.2 | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 53.7 | Not reported | 41.1 | 66.0 | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 33.3 | Not reported | 14.6 | 57.0 | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 39.4 | Not reported | 22.9 | 57.9 | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 26.3 | Not reported | 9.1 | 51.2 | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 32.0 | Not reported | 14.9 | 53.5 | Not reported |
| Dose Expansion: HER2-expressing NSCLC Tumors | 55.6 | Not reported | 30.8 | 78.5 | Not reported |
| Dose Expansion: HER2-expressing Colorectal Tumors | 5.0 | Not reported | 0.1 | 24.9 | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 30.4 | Not reported | 13.2 | 52.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 70.8
- value
- 0
- group Id
- OG001
- lower Limit
- 0.8
- upper Limit
- 90.6
- value
- 33.3
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 70.8
- value
- 0
- group Id
- OG003
- lower Limit
- 35.9
- upper Limit
- 99.6
- value
- 83.3
- group Id
- OG004
- lower Limit
- 4.3
- upper Limit
- 77.7
- value
- 33.3
- group Id
- OG005
- lower Limit
- 11.8
- upper Limit
- 88.2
- value
- 50.0
- group Id
- OG006
- lower Limit
- 36.6
- upper Limit
- 65.2
- value
- 51.0
- group Id
- OG007
- lower Limit
- 41.1
- upper Limit
- 66.0
- value
- 53.7
- group Id
- OG008
- lower Limit
- 14.6
- upper Limit
- 57.0
- value
- 33.3
- group Id
- OG009
- lower Limit
- 22.9
- upper Limit
- 57.9
- value
- 39.4
- group Id
- OG010
- lower Limit
- 9.1
- upper Limit
- 51.2
- value
- 26.3
- group Id
- OG011
- lower Limit
- 14.9
- upper Limit
- 53.5
- value
- 32.0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 51
- group Id
- OG007
- value
- 67
- group Id
- OG008
- value
- 21
- group Id
- OG009
- value
- 33
- group Id
- OG010
- value
- 19
- group Id
- OG011
- value
- 25
- units
- Participants
- description
- 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG000
- title
- Dose Escalation: Cohort 1, 0.8 mg/kg
- description
- Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG001
- title
- Dose Escalation: Cohort 2, 1.6 mg/kg
- description
- Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG002
- title
- Dose Escalation: Cohort 3, 3.2 mg/kg
- description
- Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG003
- title
- Dose Escalation: Cohort 4, 5.4 mg/kg
- description
- Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG004
- title
- Dose Escalation: Cohort 5, 6.4 mg/kg
- description
- Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG005
- title
- Dose Escalation: Cohort 6, 8.0 mg/kg
- description
- Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG006
- title
- Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
- description
- Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG007
- title
- Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
- description
- Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG008
- title
- Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
- description
- Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG009
- title
- Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
- description
- Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG010
- title
- Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
- description
- Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG011
- title
- Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
- param Type
- NUMBER
- population Description
- ORR was assessed among participants in the Intent-to-Treat Analysis Set.
- reporting Status
- POSTED
- time Frame
- From 6 months postdose of last participant up to 3 years 5 months
- title
- Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice