TriangleNCT02052778 · OUTCOME
Phase 1: Dose Escalation-Recommended Phase 2 Dose (RP2D) of TAS-120
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Milligrams
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1 (21-day cycle)
What was measured
RP2D was MTD or less. MTD: Highest dose level at which \<33% of participants experience DLT) during Cycle1. DLT: \>=Grade(G)3: - nonhematologic toxicity, - nausea/vomiting lasting \>48hrs(uncontrolled by aggressive antiemetic), - diarrhea lasting \>48hrs (unresponsive to antidiarrheal drug); G4 neutropenia lasting \>7days; Febrile neutropenia (ANC\<1000/mm\^3 with body temperature=\>38.3°C/sustained temperature \>=38°C for \>1hr; Thrombocytopenia G4/G3 with bleeding, required blood transfusion; Corneal disorder worsened by 1 grade or more; Increased phosphorus: \>=9mg/dL or \>=7mg/dL lasting for \>=7days or phosphate lowering therapy\[PLT\] for 7days); Creatinine increase (\>1.5×upper limit of normal \[ULN\]) lasting for \>=7 days associated with serum phosphorus \>5.5 mg/dL(PLT=7days)/calcium×phosphorus \>55 mg/dL(PLT=7days); Hypercalcemia G2 for \>7days or G3; Ectopic de novo calcification in soft tissues; \>G2 DLT: prevented Cycle 1 completion, inability to start Cycle 2 within 2 weeks of schedule.
Analysis population: Analysis was performed on DLT evaluable population that included all participants in Phase 1 Dose Escalation who had either experience a DLT during the first cycle of treatment or who had complete the first cycle with at least 80% of planned TAS-120 administered.
Groups in this outcome
Phase 1: Dose Escalation: QOD Dosing
Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 at 4 DLs from 8 to 36 mg orally every other day (QOD; Monday, Wednesday and Friday of each week) and participants with FGF/FGFR abnormalities received orally TAS-120 at 6 DLs from 56 mg to 240 mg QOD in a 21-day treatment cycle until disease progression, unacceptable toxicity, or any other discontinuation criterion was met (maximum exposure: 11 months).
Phase 1: Dose Escalation: QD Dosing
Participants with or without FGF/FGFR gene abnormalities received a dose between 4 to 24 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, or any other discontinuation criterion was met (maximum exposure: 24 months).
| Group | Source count |
|---|---|
| Phase 1: Dose Escalation: QOD Dosing | 42 |
| Phase 1: Dose Escalation: QD Dosing | 44 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Dose Escalation: QOD Dosing | NA | Not reported | Not reported | Not reported | MTD for QOD dosing was not determined as no DLTs were observed for TAS-120 up to 200 mg QOD as the highest dose level studied and thus no RP2D was determined. |
| Phase 1: Dose Escalation: QD Dosing | 20 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- MTD for QOD dosing was not determined as no DLTs were observed for TAS-120 up to 200 mg QOD as the highest dose level studied and thus no RP2D was determined.
- group Id
- OG000
- value
- NA
- group Id
- OG001
- value
- 20
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 44
- units
- Participants
- description
- RP2D was MTD or less. MTD: Highest dose level at which \<33% of participants experience DLT) during Cycle1. DLT: \>=Grade(G)3: - nonhematologic toxicity, - nausea/vomiting lasting \>48hrs(uncontrolled by aggressive antiemetic), - diarrhea lasting \>48hrs (unresponsive to antidiarrheal drug); G4 neutropenia lasting \>7days; Febrile neutropenia (ANC\<1000/mm\^3 with body temperature=\>38.3°C/sustained temperature \>=38°C for \>1hr; Thrombocytopenia G4/G3 with bleeding, required blood transfusion; Corneal disorder worsened by 1 grade or more; Increased phosphorus: \>=9mg/dL or \>=7mg/dL lasting for \>=7days or phosphate lowering therapy\[PLT\] for 7days); Creatinine increase (\>1.5×upper limit of normal \[ULN\]) lasting for \>=7 days associated with serum phosphorus \>5.5 mg/dL(PLT=7days)/calcium×phosphorus \>55 mg/dL(PLT=7days); Hypercalcemia G2 for \>7days or G3; Ectopic de novo calcification in soft tissues; \>G2 DLT: prevented Cycle 1 completion, inability to start Cycle 2 within 2 weeks of schedule.
- groups
- description
- Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 at 4 DLs from 8 to 36 mg orally every other day (QOD; Monday, Wednesday and Friday of each week) and participants with FGF/FGFR abnormalities received orally TAS-120 at 6 DLs from 56 mg to 240 mg QOD in a 21-day treatment cycle until disease progression, unacceptable toxicity, or any other discontinuation criterion was met (maximum exposure: 11 months).
- id
- OG000
- title
- Phase 1: Dose Escalation: QOD Dosing
- description
- Participants with or without FGF/FGFR gene abnormalities received a dose between 4 to 24 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, or any other discontinuation criterion was met (maximum exposure: 24 months).
- id
- OG001
- title
- Phase 1: Dose Escalation: QD Dosing
- param Type
- NUMBER
- population Description
- Analysis was performed on DLT evaluable population that included all participants in Phase 1 Dose Escalation who had either experience a DLT during the first cycle of treatment or who had complete the first cycle with at least 80% of planned TAS-120 administered.
- reporting Status
- POSTED
- time Frame
- Cycle 1 (21-day cycle)
- title
- Phase 1: Dose Escalation-Recommended Phase 2 Dose (RP2D) of TAS-120
- type
- PRIMARY
- unit Of Measure
- Milligrams
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice