NCT02124772 · OUTCOME
Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire
Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations · Source last updated 2021-07-14
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
- After the first dose of dabrafenib oral suspension and no later than Day 8 (±3 days)
What was measured
For subjects ≥ 12 years of age who received the dabrafenib suspension, the subject completed a form to evaluate the various properties of the suspension (e.g., bitterness, sweetness, appearance, texture and overall taste). For subjects \< 12 years of age who received the suspension, their caregiver (e.g. parent or guardian) evaluated the suspension with the child based on verbal and non-verbal feedback. The questionnaire was completed after the first dose of study drug and no later than Day 8 (±3 days). Subjects completed a form for each drug separately if enrolled in Parts C and D.
Analysis population: All subjects who received at least one dose of dabrafenib oral suspension and filled in the palatability questionnaire.
All palatability questionnaire results were combined and reported based on drug dose to better determine the acceptability and palatability of the formulation. There were no results available for participants who received 50% of the RP2D of dabrafenib monotherapy in combination with trametinib because the participants did not fill in the questionnaire.
Groups in this outcome
TMT 0.025 mg/kg/Day + 50% DRB RP2D
Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the RP2D of dabrafenib monotherapy (oral suspension formulation)
TMT 0.025 mg/kg/Day + 100% DRB RP2D
Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the RP2D of dabrafenib monotherapy (oral suspension formulation)
TMT 0.032 mg/kg/Day + 100% DRB RP2D
Participants treated with a combination therapy of trametinib (0.032 mg/kg/day) plus 100% of the RP2D of dabrafenib monotherapy (oral suspension formulation)
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 |
|---|
| TMT 0.025 mg/kg/Day + 50% DRB RP2D | 0 |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 4 |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 6 |
|---|
Reported measurements
Was the medicine difficult to mix?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Was the medicine difficult to measure?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Was the medicine difficult to administer?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did the subject like the taste of the medicine?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did the subject have difficulty in taking the medicine?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did the subject resist taking the medicine?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Was the medicine bitter?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Was the medicine sweet?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Was the medicine sour?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Was the medicine gritty?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Was the medicine difficult to swallow?
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TMT 0.025 mg/kg/Day + 100% DRB RP2D | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| TMT 0.032 mg/kg/Day + 100% DRB RP2D | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Yes
- measurements
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- title
- No
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- missing
- title
- Was the medicine difficult to mix?
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Yes
- measurements
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- title
- No
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- missing
- title
- Was the medicine difficult to measure?
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Yes
- measurements
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- title
- No
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- missing
- title
- Was the medicine difficult to administer?
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- title
- Yes
- measurements
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- title
- No
- measurements
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- title
- missing
- title
- Did the subject like the taste of the medicine?
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- title
- Yes
- measurements
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- title
- No
- measurements
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- title
- missing
- title
- Did the subject have difficulty in taking the medicine?
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- title
- Yes
- measurements
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- title
- No
- measurements
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- title
- missing
- title
- Did the subject resist taking the medicine?
- categories
- measurements
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- Yes
- measurements
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- title
- No
- measurements
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 6
- title
- missing
- title
- Was the medicine bitter?
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Yes
- measurements
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- title
- No
- measurements
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 6
- title
- missing
- title
- Was the medicine sweet?
- categories
- measurements
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- title
- Yes
- measurements
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- No
- measurements
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 6
- title
- missing
- title
- Was the medicine sour?
- categories
- measurements
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- Yes
- measurements
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- title
- No
- measurements
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 6
- title
- missing
- title
- Was the medicine gritty?
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Yes
- measurements
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- title
- No
- measurements
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 6
- title
- missing
- title
- Was the medicine difficult to swallow?
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- For subjects ≥ 12 years of age who received the dabrafenib suspension, the subject completed a form to evaluate the various properties of the suspension (e.g., bitterness, sweetness, appearance, texture and overall taste). For subjects \< 12 years of age who received the suspension, their caregiver (e.g. parent or guardian) evaluated the suspension with the child based on verbal and non-verbal feedback. The questionnaire was completed after the first dose of study drug and no later than Day 8 (±3 days). Subjects completed a form for each drug separately if enrolled in Parts C and D.
- groups
- description
- Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the RP2D of dabrafenib monotherapy (oral suspension formulation)
- id
- OG000
- title
- TMT 0.025 mg/kg/Day + 50% DRB RP2D
- description
- Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the RP2D of dabrafenib monotherapy (oral suspension formulation)
- id
- OG001
- title
- TMT 0.025 mg/kg/Day + 100% DRB RP2D
- description
- Participants treated with a combination therapy of trametinib (0.032 mg/kg/day) plus 100% of the RP2D of dabrafenib monotherapy (oral suspension formulation)
- id
- OG002
- title
- TMT 0.032 mg/kg/Day + 100% DRB RP2D
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All subjects who received at least one dose of dabrafenib oral suspension and filled in the palatability questionnaire.
All palatability questionnaire results were combined and reported based on drug dose to better determine the acceptability and palatability of the formulation. There were no results available for participants who received 50% of the RP2D of dabrafenib monotherapy in combination with trametinib because the participants did not fill in the questionnaire.
- reporting Status
- POSTED
- time Frame
- After the first dose of dabrafenib oral suspension and no later than Day 8 (±3 days)
- title
- Palatability of Dabrafenib Oral Suspension in Pediatric Subjects Assessed by Palatability Questionnaire
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice
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