TriangleNCT02371369 · OUTCOME
Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response Based on Tumor Volume Score (TVS) After Receiving Pexidartinib Compared With Those on Placebo at Week 25
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
- Week 25
What was measured
Complete response (CR) and partial response (PR) were assessed using tumor volume score (TVS). 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. TVS is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor.
Analysis population: Best overall response was assessed in the ITT population.
Groups in this outcome
Pexidartinib Part 1
Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
Placebo Part 1
Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.
| Group | Source count |
|---|---|
| Pexidartinib Part 1 | 61 |
| Placebo Part 1 | 59 |
Reported measurements
Complete Response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 | 4.9 | Not reported | Not reported | Not reported | Not reported |
| Placebo Part 1 | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 | 50.8 | Not reported | Not reported | Not reported | Not reported |
| Placebo Part 1 | 0 | Not reported | Not reported | Not reported | Not reported |
Response (CR or PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 | 55.7 | Not reported | Not reported | Not reported | Not reported |
| Placebo Part 1 | 0 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Description
- Treatment comparison between the pexidartinib and placebo groups at Week 25
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Treatment comparison analysis
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- statistical Method
- Fisher's Exact Test
Complete source fields
- analyses
- group Description
- Treatment comparison between the pexidartinib and placebo groups at Week 25
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Treatment comparison analysis
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- statistical Method
- Fisher's Exact Test
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4.9
- group Id
- OG001
- value
- 0
- title
- Complete Response (CR)
- categories
- measurements
- group Id
- OG000
- value
- 50.8
- group Id
- OG001
- value
- 0
- title
- Partial Response (PR)
- categories
- measurements
- group Id
- OG000
- value
- 55.7
- group Id
- OG001
- value
- 0
- title
- Response (CR or PR)
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 59
- units
- Participants
- description
- Complete response (CR) and partial response (PR) were assessed using tumor volume score (TVS). 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. TVS is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor.
- 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 Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
- id
- OG000
- title
- Pexidartinib Part 1
- description
- Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.
- id
- OG001
- title
- Placebo Part 1
- param Type
- NUMBER
- population Description
- Best overall response was assessed in the ITT population.
- reporting Status
- POSTED
- time Frame
- Week 25
- title
- Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response Based on Tumor Volume Score (TVS) After Receiving Pexidartinib Compared With Those on Placebo at Week 25
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice