TriangleNCT03974022 · OUTCOME
Part A Dose Escalation and Expansion: Cmax,ss, at Steady State of DZD9008
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 2 Day 1: 0 (predose) up to 24 hours (for Part A Dose expansion and expansion)
What was measured
Maximum observed plasma concentration(ng/mL), at steady state, obtained directly from the observed concentration versus time data. Calculated for the multiple dose.
Analysis population: All participants who have received at least one dose of study drug with at least one measurable plasma concentration of DZD9008 post dose without any important deviations or events that would exclude the participants.
Groups in this outcome
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 50 mg once daily continuously.
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 100 mg once daily continuously.
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 200 mg once daily continuously.
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 300 mg once daily continuously.
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 400 mg once daily continuously.
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment. No patient was enrolled into this cohort.
| Group | Source count |
|---|---|
| Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg | 3 |
| Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg | 5 |
| Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg | 2 |
| Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg | 3 |
| Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg | 3 |
| Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State | 9 |
| Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State | 10 |
| Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal | 9 |
| Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal | 4 |
| Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal | 19 |
| Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg | 82.85 | 17.2 | Not reported | Not reported | Not reported |
| Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg | 229.4 | 50.6 | Not reported | Not reported | Not reported |
| Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg | NA | NA | Not reported | Not reported | Not calculable, insufficient number of participants for calculation after excluding the data impacted by prohibited medication co-administration. |
| Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg | 590.2 | 80.9 | Not reported | Not reported | Not reported |
| Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg | 677.0 | 21.9 | Not reported | Not reported | Not reported |
| Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State | 358.0 | 53.4 | Not reported | Not reported | Not reported |
| Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State | 717.5 | 40.9 | Not reported | Not reported | Not reported |
| Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal | 613.3 | 48.8 | Not reported | Not reported | Not reported |
| Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal | 819.3 | 57.3 | Not reported | Not reported | Not reported |
| Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal | 716.5 | 41.7 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 17.2
- value
- 82.85
- group Id
- OG001
- spread
- 50.6
- value
- 229.4
- comment
- Not calculable, insufficient number of participants for calculation after excluding the data impacted by prohibited medication co-administration.
- group Id
- OG002
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 80.9
- value
- 590.2
- group Id
- OG004
- spread
- 21.9
- value
- 677.0
- group Id
- OG005
- spread
- 53.4
- value
- 358.0
- group Id
- OG006
- spread
- 40.9
- value
- 717.5
- group Id
- OG007
- spread
- 48.8
- value
- 613.3
- group Id
- OG008
- spread
- 57.3
- value
- 819.3
- group Id
- OG009
- spread
- 41.7
- value
- 716.5
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 19
- group Id
- OG010
- value
- 0
- units
- Participants
- description
- Maximum observed plasma concentration(ng/mL), at steady state, obtained directly from the observed concentration versus time data. Calculated for the multiple dose.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 50 mg once daily continuously.
- id
- OG000
- title
- Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
- description
- Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 100 mg once daily continuously.
- id
- OG001
- title
- Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
- description
- Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 200 mg once daily continuously.
- id
- OG002
- title
- Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
- description
- Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 300 mg once daily continuously.
- id
- OG003
- title
- Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
- description
- Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 400 mg once daily continuously.
- id
- OG004
- title
- Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
- description
- Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
- id
- OG005
- title
- Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
- description
- Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
- id
- OG006
- title
- Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
- description
- Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
- id
- OG007
- title
- Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
- description
- Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
- id
- OG008
- title
- Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
- description
- Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
- id
- OG009
- title
- Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
- description
- Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment. No patient was enrolled into this cohort.
- id
- OG010
- title
- Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- All participants who have received at least one dose of study drug with at least one measurable plasma concentration of DZD9008 post dose without any important deviations or events that would exclude the participants.
- reporting Status
- POSTED
- time Frame
- Cycle 2 Day 1: 0 (predose) up to 24 hours (for Part A Dose expansion and expansion)
- title
- Part A Dose Escalation and Expansion: Cmax,ss, at Steady State of DZD9008
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice