NCT02371369 · OUTCOME
Number of Responders to Pexidartinib With and Without Disease Progression
Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS) · Source last updated 2022-05-11
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- By Week 96
What was measured
Duration of response (DOR) based on RECIST 1.1 is defined as the date of the first recorded response to the first date of documented disease progression. The overall number of responses and the number of participants with and without disease progression was assessed.
Analysis population: The overall number of responses and the number of participants with and without disease progression were assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Pexidartinib Part 2 only, All Pexidartinib Treated participants, . Participants randomized to Placebo Part 1 only were not analyzed.
Groups in this outcome
Pexidartinib Part 1 and Part 2
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
Part 2: Participants also received pexidartinib at their prescribed dose.
Pexidartinib: Each capsule contains 200 mg of pexidartinib for oral administration
Placebo Part 1, Pexidartinib Part 2
Participants that received placebo in part 1 and received Pexidartinib in Part 2 at their prescribed dose.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Pexidartinib Part 1 and Part 2 | 61 |
|---|
| Placebo Part 1, Pexidartinib Part 2 | 30 |
|---|
| All Pexidartinib Treated | 91 |
|---|
Reported measurements
Number of responses
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pexidartinib Part 1 and Part 2 | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Part 1, Pexidartinib Part 2 | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Pexidartinib Treated | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 12 (Day 84); Without disease progression
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pexidartinib Part 1 and Part 2 | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Part 1, Pexidartinib Part 2 | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Pexidartinib Treated | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 12 (Day 84); With disease progression
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pexidartinib Part 1 and Part 2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Part 1, Pexidartinib Part 2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Pexidartinib Treated | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 24 (Day 168); Without disease progression
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pexidartinib Part 1 and Part 2 | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Part 1, Pexidartinib Part 2 | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Pexidartinib Treated | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 24 (Day 168); With disease progression
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pexidartinib Part 1 and Part 2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Part 1, Pexidartinib Part 2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Pexidartinib Treated | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 48 (Day 336); Without disease progression
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pexidartinib Part 1 and Part 2 | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Part 1, Pexidartinib Part 2 | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Pexidartinib Treated | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 48 (Day 336); With disease progression
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pexidartinib Part 1 and Part 2 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Part 1, Pexidartinib Part 2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Pexidartinib Treated | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 72 (Day 504); Without disease progression
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pexidartinib Part 1 and Part 2 | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Part 1, Pexidartinib Part 2 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Pexidartinib Treated | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 72 (Day 504); With disease progression
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pexidartinib Part 1 and Part 2 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Part 1, Pexidartinib Part 2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Pexidartinib Treated | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 96 (Day 672); Without disease progression
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pexidartinib Part 1 and Part 2 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Part 1, Pexidartinib Part 2 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Pexidartinib Treated | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 96 (Day 672); With disease progression
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pexidartinib Part 1 and Part 2 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Part 1, Pexidartinib Part 2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| All Pexidartinib Treated | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 35
- title
- Number of responses
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 35
- title
- Week 12 (Day 84); Without disease progression
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Week 12 (Day 84); With disease progression
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 35
- title
- Week 24 (Day 168); Without disease progression
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Week 24 (Day 168); With disease progression
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 24
- title
- Week 48 (Day 336); Without disease progression
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Week 48 (Day 336); With disease progression
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 12
- title
- Week 72 (Day 504); Without disease progression
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Week 72 (Day 504); With disease progression
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- title
- Week 96 (Day 672); Without disease progression
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Week 96 (Day 672); With disease progression
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 91
- units
- Participants
- description
- Duration of response (DOR) based on RECIST 1.1 is defined as the date of the first recorded response to the first date of documented disease progression. The overall number of responses and the number of participants with and without disease progression was assessed.
- groups
- description
- 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
Part 2: Participants also received pexidartinib 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 that received placebo in part 1 and received Pexidartinib in Part 2 at their prescribed dose.
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
- The overall number of responses and the number of participants with and without disease progression were assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Pexidartinib Part 2 only, All Pexidartinib Treated participants, . Participants randomized to Placebo Part 1 only were not analyzed.
- reporting Status
- POSTED
- time Frame
- By Week 96
- title
- Number of Responders to Pexidartinib With and Without Disease Progression
- type
- SECONDARY
- unit Of Measure
- participants
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