TriangleNCT04209465 · OUTCOME
Phase 1: Objective Response Rate as a Preliminary Measure of Antitumor Activity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Assessed until disease progression or death for up to 12 months
What was measured
Objective response is defined as the proportion of participants who achieved a complete response (CR; disappearance of all target and non-target lesions) or partial response (PR; at least a 30% decrease from baseline in the sum of diameters of target lesions) per RECIST version 1.1.
Groups in this outcome
Dose Escalation 25 mg QD
Patients who received doses at 25 mg once daily under fasted conditions.
Dose Escalation 50 mg QD
Patients who received doses at 50 mg once daily under fasted conditions.
Dose Escalation 100 mg QD
Patients who received doses at 100 mg once daily under fasted conditions.
Dose Escalation 200 mg QD
Patients who received doses at 200 mg once daily under fasted conditions.
Dose Escalation 400 mg QD
Patients who received 400 mg once daily under fasted conditions.
Dose Escalation 800 mg QD
Patients who received 800 mg once daily under fasted conditions.
Dose Escalation 800 mg QD NF
Patients who received 800 mg once daily under not fasted conditions.
Dose Escalation 1000 mg QD
Patients who received 1000 mg once daily under fasted conditions.
Dose Escalation 1200 mg QD
Patients who received 1200 mg once daily under fasted conditions.
Dose Escalation 400 mg BID
Patients who received 400 mg twice daily under not fasted conditions.
Dose Escalation 600 mg BID
Patients who received 600 mg twice daily under not fasted conditions.
Dose Escalation 800 mg BID
Patients who received 800 mg twice daily under fasted conditions.
Safety Expansion 800 mg QD
Safety expansion patients who received 800 mg once daily under not fasted conditions.
| Group | Source count |
|---|---|
| Dose Escalation 25 mg QD | 1 |
| Dose Escalation 50 mg QD | 1 |
| Dose Escalation 100 mg QD | 1 |
| Dose Escalation 200 mg QD | 2 |
| Dose Escalation 400 mg QD | 10 |
| Dose Escalation 800 mg QD | 18 |
| Dose Escalation 800 mg QD NF | 13 |
| Dose Escalation 1000 mg QD | 7 |
| Dose Escalation 1200 mg QD | 6 |
| Dose Escalation 400 mg BID | 4 |
| Dose Escalation 600 mg BID | 6 |
| Dose Escalation 800 mg BID | 5 |
| Safety Expansion 800 mg QD | 17 |
Reported measurements
Source class 1
Complete response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation 25 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 50 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 100 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 200 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 400 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg QD NF | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 1000 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 1200 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 400 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 600 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Safety Expansion 800 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
Partial response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation 25 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 50 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 100 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 200 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 400 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg QD NF | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 1000 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 1200 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 400 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 600 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Safety Expansion 800 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
Stable disease (SD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation 25 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 50 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 100 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 200 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 400 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg QD | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg QD NF | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 1000 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 1200 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 400 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 600 mg BID | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Safety Expansion 800 mg QD | 7 | Not reported | Not reported | Not reported | Not reported |
Non-complete response/non-partial response (non-CR/non-PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation 25 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 50 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 100 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 200 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 400 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg QD NF | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 1000 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 1200 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 400 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 600 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Safety Expansion 800 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
Progressive disease (PD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation 25 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 50 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 100 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 200 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 400 mg QD | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg QD NF | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 1000 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 1200 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 400 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 600 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg BID | 3 | Not reported | Not reported | Not reported | Not reported |
| Safety Expansion 800 mg QD | 8 | Not reported | Not reported | Not reported | Not reported |
Not evaluable (NE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation 25 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 50 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 100 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 200 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 400 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg QD NF | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 1000 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 1200 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 400 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 600 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
| Safety Expansion 800 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Complete response (CR)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Partial response (PR)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 1
- title
- Stable disease (SD)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Non-complete response/non-partial response (non-CR/non-PR)
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 3
- title
- Progressive disease (PD)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 1
- title
- Not evaluable (NE)
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 18
- group Id
- OG006
- value
- 13
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 6
- group Id
- OG011
- value
- 5
- units
- Participants
- description
- Objective response is defined as the proportion of participants who achieved a complete response (CR; disappearance of all target and non-target lesions) or partial response (PR; at least a 30% decrease from baseline in the sum of diameters of target lesions) per RECIST version 1.1.
- groups
- description
- Patients who received doses at 25 mg once daily under fasted conditions.
- id
- OG000
- title
- Dose Escalation 25 mg QD
- description
- Patients who received doses at 50 mg once daily under fasted conditions.
- id
- OG001
- title
- Dose Escalation 50 mg QD
- description
- Patients who received doses at 100 mg once daily under fasted conditions.
- id
- OG002
- title
- Dose Escalation 100 mg QD
- description
- Patients who received doses at 200 mg once daily under fasted conditions.
- id
- OG003
- title
- Dose Escalation 200 mg QD
- description
- Patients who received 400 mg once daily under fasted conditions.
- id
- OG004
- title
- Dose Escalation 400 mg QD
- description
- Patients who received 800 mg once daily under fasted conditions.
- id
- OG005
- title
- Dose Escalation 800 mg QD
- description
- Patients who received 800 mg once daily under not fasted conditions.
- id
- OG006
- title
- Dose Escalation 800 mg QD NF
- description
- Patients who received 1000 mg once daily under fasted conditions.
- id
- OG007
- title
- Dose Escalation 1000 mg QD
- description
- Patients who received 1200 mg once daily under fasted conditions.
- id
- OG008
- title
- Dose Escalation 1200 mg QD
- description
- Patients who received 400 mg twice daily under not fasted conditions.
- id
- OG009
- title
- Dose Escalation 400 mg BID
- description
- Patients who received 600 mg twice daily under not fasted conditions.
- id
- OG010
- title
- Dose Escalation 600 mg BID
- description
- Patients who received 800 mg twice daily under fasted conditions.
- id
- OG011
- title
- Dose Escalation 800 mg BID
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Assessed until disease progression or death for up to 12 months
- title
- Phase 1: Objective Response Rate as a Preliminary Measure of Antitumor Activity
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice