NCT02393248 · OUTCOME
Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hr
- Interval / dispersion
- Full Range
- Time frame
- predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
What was measured
tmax was defined as the time to the maximum observed plasma concentration.
Analysis population: PK/PD Population. Only participants with available data were analyzed.
Groups in this outcome
Part 3: Pem/Intermittent Pemigatinib 9 mg
Participants received pembrolizumab (Pem) intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.
Part 3: Pem/Intermittent Pemigatinib 13.5 mg
Participants received pembrolizumab intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg
Participants received gemcitabine intravenously starting at 1000 mg/m\^2 on Days 1 and 8 of each 21-day cycle. Cisplatin was administered intravenously starting at 70 mg/m\^2 once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.
Part 3: Doc/Intermittent Pemigatinib 13.5 mg
Participants received docetaxel (Doc) intravenously starting at 75 mg/m\^2 once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of docetaxel.
Part 3: Tras/Intermittent Pemigatinib 13.5 mg
Trastuzumab (Tras) was administered as an open-label, commercial product at an initial intravenous dose of 8 mg/kilograms (kg), followed by 6 mg/kg intravenously once every 3 weeks. The dose could have been adjusted for toxicity management, per commercial labeling. The investigator could have interrupted, modified, or discontinued trastuzumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of trastuzumab.
| Group | Source count |
|---|---|
| Part 3: Pem/Intermittent Pemigatinib 9 mg | 3 |
| Part 3: Pem/Intermittent Pemigatinib 13.5 mg | 14 |
| Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg | 4 |
| Part 3: Doc/Intermittent Pemigatinib 13.5 mg | 5 |
| Part 3: Tras/Intermittent Pemigatinib 13.5 mg | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3: Pem/Intermittent Pemigatinib 9 mg | 5.78 | Not reported | 1.25 | 6.08 | Not reported |
| Part 3: Pem/Intermittent Pemigatinib 13.5 mg | 1.08 | Not reported | 0.500 | 7.98 | Not reported |
| Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg | 1.50 | Not reported | 0.950 | 4.00 | Not reported |
| Part 3: Doc/Intermittent Pemigatinib 13.5 mg | 1.90 | Not reported | 0.500 | 2.08 | Not reported |
| Part 3: Tras/Intermittent Pemigatinib 13.5 mg | 0.583 | Not reported | 0.500 | 1.07 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.25
- upper Limit
- 6.08
- value
- 5.78
- group Id
- OG001
- lower Limit
- 0.500
- upper Limit
- 7.98
- value
- 1.08
- group Id
- OG002
- lower Limit
- 0.950
- upper Limit
- 4.00
- value
- 1.50
- group Id
- OG003
- lower Limit
- 0.500
- upper Limit
- 2.08
- value
- 1.90
- group Id
- OG004
- lower Limit
- 0.500
- upper Limit
- 1.07
- value
- 0.583
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 5
- units
- Participants
- description
- tmax was defined as the time to the maximum observed plasma concentration.
- dispersion Type
- Full Range
- groups
- description
- Participants received pembrolizumab (Pem) intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.
- id
- OG000
- title
- Part 3: Pem/Intermittent Pemigatinib 9 mg
- description
- Participants received pembrolizumab intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.
- id
- OG001
- title
- Part 3: Pem/Intermittent Pemigatinib 13.5 mg
- description
- Participants received gemcitabine intravenously starting at 1000 mg/m\^2 on Days 1 and 8 of each 21-day cycle. Cisplatin was administered intravenously starting at 70 mg/m\^2 once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.
- id
- OG002
- title
- Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg
- description
- Participants received docetaxel (Doc) intravenously starting at 75 mg/m\^2 once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of docetaxel.
- id
- OG003
- title
- Part 3: Doc/Intermittent Pemigatinib 13.5 mg
- description
- Trastuzumab (Tras) was administered as an open-label, commercial product at an initial intravenous dose of 8 mg/kilograms (kg), followed by 6 mg/kg intravenously once every 3 weeks. The dose could have been adjusted for toxicity management, per commercial labeling. The investigator could have interrupted, modified, or discontinued trastuzumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of trastuzumab.
- id
- OG004
- title
- Part 3: Tras/Intermittent Pemigatinib 13.5 mg
- param Type
- MEDIAN
- population Description
- PK/PD Population. Only participants with available data were analyzed.
- reporting Status
- POSTED
- time Frame
- predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
- title
- Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
- type
- SECONDARY
- unit Of Measure
- hr
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Preserved source evidence · Not medical advice
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