TriangleNCT02371369 · OUTCOME
Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response to Pexidartinib Compared With That of Placebo Per Response Evaluation Criteria in Solid Tumors Version 1.1 by Week 49
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
- Not reported
- Time frame
- By Week 49
What was measured
Complete (CR) and partial responses (PR) were assessed based on centrally-read magnetic resonance imaging (MRI) scans and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference.
Analysis population: Best overall response was assessed in the ITT population.
Groups in this outcome
Pexidartinib Part 1 and Part 2
Participants received treatment of Pexidartinib,1000 mg (5 capsules per day) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks and also received Pexidartinib in Part 2 at their prescribed dose. Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
Placebo Part 1, Pexidartinib Part 2
Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose. Placebo: Placebo capsule matching Pexidartinib capsule for oral administration Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
All Pexidartinib Treated
All participants who received Pexidartinib in Part 1 and Part 2 as well as those who only received Pexidartinib in Part 2.
| Group | Source count |
|---|---|
| Pexidartinib Part 1 and Part 2 | 61 |
| Placebo Part 1, Pexidartinib Part 2 | 30 |
| All Pexidartinib Treated | 91 |
Reported measurements
Complete Response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 and Part 2 | 24.6 | Not reported | Not reported | Not reported | Not reported |
| Placebo Part 1, Pexidartinib Part 2 | 23.3 | Not reported | Not reported | Not reported | Not reported |
| All Pexidartinib Treated | 24.2 | Not reported | Not reported | Not reported | Not reported |
Partial Response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 and Part 2 | 29.5 | Not reported | Not reported | Not reported | Not reported |
| Placebo Part 1, Pexidartinib Part 2 | 30.0 | Not reported | Not reported | Not reported | Not reported |
| All Pexidartinib Treated | 29.7 | Not reported | Not reported | Not reported | Not reported |
Response (CR or PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 and Part 2 | 54.1 | Not reported | Not reported | Not reported | Not reported |
| Placebo Part 1, Pexidartinib Part 2 | 53.3 | Not reported | Not reported | Not reported | Not reported |
| All Pexidartinib Treated | 53.8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 24.6
- group Id
- OG001
- value
- 23.3
- group Id
- OG002
- value
- 24.2
- title
- Complete Response (CR)
- categories
- measurements
- group Id
- OG000
- value
- 29.5
- group Id
- OG001
- value
- 30.0
- group Id
- OG002
- value
- 29.7
- title
- Partial Response (PR)
- categories
- measurements
- group Id
- OG000
- value
- 54.1
- group Id
- OG001
- value
- 53.3
- group Id
- OG002
- value
- 53.8
- title
- Response (CR or PR)
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 91
- units
- Participants
- description
- Complete (CR) and partial responses (PR) were assessed based on centrally-read magnetic resonance imaging (MRI) scans and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference.
- groups
- description
- Participants received treatment of Pexidartinib,1000 mg (5 capsules per day) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks and also received Pexidartinib in Part 2 at their prescribed dose. Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
- id
- OG000
- title
- Pexidartinib Part 1 and Part 2
- description
- Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose. Placebo: Placebo capsule matching Pexidartinib capsule for oral administration Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
- id
- OG001
- title
- Placebo Part 1, Pexidartinib Part 2
- description
- All participants who received Pexidartinib in Part 1 and Part 2 as well as those who only received Pexidartinib in Part 2.
- id
- OG002
- title
- All Pexidartinib Treated
- param Type
- NUMBER
- population Description
- Best overall response was assessed in the ITT population.
- reporting Status
- POSTED
- time Frame
- By Week 49
- title
- Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response to Pexidartinib Compared With That of Placebo Per Response Evaluation Criteria in Solid Tumors Version 1.1 by Week 49
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice