TriangleNCT02564900 · OUTCOME
Time to Response (TTR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From 6 months postdose of last participant up to 3 years 5 months
What was measured
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.
Analysis population: Time to response was assessed among participants who achieved CR or PR in the Intent-to-Treat Analysis Set.
Groups in this outcome
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 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 Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 2.7 | Not reported | 1.5 | 2.9 | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 2.8 | Not reported | 1.4 | 2.9 | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 2.6 | Not reported | 1.2 | 4.2 | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 2.7 | Not reported | 1.2 | 3.1 | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 1.6 | Not reported | 1.2 | 3.1 | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 2.2 | Not reported | 1.4 | 2.9 | Not reported |
| Dose Expansion: HER2-expressing NSCLC Tumors | 1.4 | Not reported | 1.2 | 2.8 | Not reported |
| Dose Expansion: HER2-expressing Colorectal Tumors | 3.0 | Not reported | NA | NA | The 95% confidence interval was not calculable due to insufficient number of participants with events. |
| Dose Expansion: HER2-expressing Other Solid Tumors | 1.6 | Not reported | 1.2 | 2.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.5
- upper Limit
- 2.9
- value
- 2.7
- group Id
- OG001
- lower Limit
- 1.4
- upper Limit
- 2.9
- value
- 2.8
- group Id
- OG002
- lower Limit
- 1.2
- upper Limit
- 4.2
- value
- 2.6
- group Id
- OG003
- lower Limit
- 1.2
- upper Limit
- 3.1
- value
- 2.7
- group Id
- OG004
- lower Limit
- 1.2
- upper Limit
- 3.1
- value
- 1.6
- group Id
- OG005
- lower Limit
- 1.4
- upper Limit
- 2.9
- value
- 2.2
- group Id
- OG006
- lower Limit
- 1.2
- upper Limit
- 2.8
- value
- 1.4
- comment
- The 95% confidence interval was not calculable due to insufficient number of participants with events.
- group Id
- OG007
- lower Limit
- NA
- upper Limit
- NA
- value
- 3.0
- group Id
- OG008
- lower Limit
- 1.2
- upper Limit
- 2.9
- value
- 1.6
- denoms
- counts
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 67
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 33
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 25
- group Id
- OG006
- value
- 18
- group Id
- OG007
- value
- 20
- group Id
- OG008
- value
- 23
- units
- Participants
- description
- 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG000
- 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
- OG001
- 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
- OG002
- 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
- OG003
- 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
- OG004
- 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
- OG005
- title
- Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
- description
- Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG006
- title
- Dose Expansion: HER2-expressing NSCLC Tumors
- description
- Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG007
- title
- Dose Expansion: HER2-expressing Colorectal Tumors
- description
- 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).
- id
- OG008
- title
- Dose Expansion: HER2-expressing Other Solid Tumors
- param Type
- MEDIAN
- population Description
- Time to response was assessed among participants who achieved CR or PR 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
- Time to Response (TTR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice