TriangleNCT03157128 · OUTCOME
Phase 1: Maximum Tolerated Dose (MTD)
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 (cycle length = 28 days)
What was measured
The MTD is defined as the highest dose level at which none of the first 3 treated patients, or not more than 1 of the first 6 treated patients, experiences a DLT. A DLT is any adverse events that starts on or after first administration of study drug, as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. * Any Grade(G) ≥3 nonhematologic toxicity, excluding * G3 AST, ALT, and/or total bilirubin elevation for \<7 days. * G3 neutropenia \<7 days * G3 thrombocytopenia without clinically significant bleeding * G3 or G4 lymphopenia. * First occurrence of G3 or G4 electrolyte abnormalities * G3 fatigue, weakness, nausea; other manageable constitutional symptom * G3 or G4 vomiting or diarrhea that lasts for \<48hours with antiemetic/antidiarrheal medication in case of G3 and \<24 hours in case of G4 * G4 manageable constitutional symptom.
Analysis population: All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.
Groups in this outcome
Phase 1 - Selpercatinib (All Participants)
All Phase 1 Participants who received Selpercatinib (20 mg - 240 mg) orally once daily (QD) or twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
| Group | Source count |
|---|---|
| Phase 1 - Selpercatinib (All Participants) | 827 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 - Selpercatinib (All Participants) | 160 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 160
- denoms
- counts
- group Id
- OG000
- value
- 827
- units
- Participants
- description
- The MTD is defined as the highest dose level at which none of the first 3 treated patients, or not more than 1 of the first 6 treated patients, experiences a DLT. A DLT is any adverse events that starts on or after first administration of study drug, as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. * Any Grade(G) ≥3 nonhematologic toxicity, excluding * G3 AST, ALT, and/or total bilirubin elevation for \<7 days. * G3 neutropenia \<7 days * G3 thrombocytopenia without clinically significant bleeding * G3 or G4 lymphopenia. * First occurrence of G3 or G4 electrolyte abnormalities * G3 fatigue, weakness, nausea; other manageable constitutional symptom * G3 or G4 vomiting or diarrhea that lasts for \<48hours with antiemetic/antidiarrheal medication in case of G3 and \<24 hours in case of G4 * G4 manageable constitutional symptom.
- groups
- description
- All Phase 1 Participants who received Selpercatinib (20 mg - 240 mg) orally once daily (QD) or twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- OG000
- title
- Phase 1 - Selpercatinib (All Participants)
- param Type
- NUMBER
- population Description
- All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.
- reporting Status
- POSTED
- time Frame
- Cycle 1 (cycle length = 28 days)
- title
- Phase 1: Maximum Tolerated Dose (MTD)
- type
- PRIMARY
- unit Of Measure
- milligrams
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice