Trial · NCT03157128
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Maximum Tolerated Dose (MTD) | Cycle 1 (cycle length = 28 days) | 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. |
| Primary | Phase 1: Recommended Phase 2 Dose (RP2D) | Cycle 1 (cycle length = 28 days) | Phase 1: RP2D |
| Primary | Phase 2: Objective Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment | Approximately for up to 7 years 8 months | Objective Response Rate was defined as the percentage of participants with best overall response of confirmed response (CR), or Partial response (PR). Response was confirmed by a repeat assessment no less than 28 days. * CR is defined as disappearance of all target lesions. * PR is defined as at least a 30% decrease in the sum of diameter (LD for non-nodal lesions and short axis diameter \[SAD\] for nodal lesions) of target lesions, taking as reference the baseline sum LD. ORR was assessed by independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 95% confidence interval was calculated using Clopper-Pearson method. |
| Secondary | Phase 1: Number of Participants With a Treatment-Related Adverse Event(s) (TRAE[s]) | Up to 28 days | Phase 1: Number of Participants with a TRAE(s) is reported. |
| Secondary | Phase 1: Number of Participants With an Abnormal Laboratory Values | Up to 28 days | |
| Secondary | Phase 2: Overall Response Rate (ORR) Based on RECIST 1.1 or RANO, as Appropriate to Tumor Type | Approximately for up to 9 years 8 months | Phase 2: ORR based on RECIST 1.1 or RANO, as Appropriate to Tumor Type |
| Secondary | Phase 2: ORR (by Investigator) | Approximately for up to 9 years 8 months | Phase 2: ORR (by Investigator) |
| Secondary | Phase 2: Best Change in Tumor Size From Baseline (by IRC and Investigator) | Approximately for up to 9 years 8 months | Phase 2: Best Change in Tumor Size from Baseline (by IRC and Investigator) |
| Secondary | Phase 2: Duration of Response (DOR; by IRC and Investigator) | Approximately for up to 9 years 8 months | Phase 2: DOR (by IRC and Investigator) |
| Secondary | Phase 2: Central Nervous System (CNS) ORR (by IRC) | Approximately for up to 9 years 8 months | Phase 2: CNS ORR (by IRC) |
| Secondary | Phase 2: CNS DOR (by IRC) | Approximately for up to 9 years 8 months | Phase 2: CNS DOR (by IRC) |
| Secondary | Phase 2: Time to Any and Best Response (by IRC and Investigator) | Approximately for up to 9 years 8 months | Phase 2: Time to Any and Best Response (by IRC and Investigator) |
| Secondary | Phase 2: CBR (by IRC and Investigator) | Approximately for up to 9 years 8 months | Phase 2: CBR (by IRC and Investigator) |
| Secondary | Phase 2: PFS (by IRC and Investigator) | Approximately for up to 9 years 8 months | Phase 2: PFS (by IRC and Investigator) |
| Secondary | Phase 2: Overall Survival (OS) | Approximately for up to 9 years 8 months | Phase 2: OS |
| Secondary | Phase 2: Percentage of Participants With Any Serious Adverse Event (SAE[s]) | Approximately for up to 9 years 8 months | Phase 2: Percentage of Participants with any SAE(s) |
| Secondary | Phase 2: Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve of LOXO-292 (Selpercatinib) | Cycle 5 Day 1 (Cycle = 28 days) | Phase 2: PK: AUC of LOXO-292 (Selpercatinib) |
| Secondary | Phase 2: PK: Maximum Concentration (Cmax) of LOXO-292 (Selpercatinib) | Cycle 5 Day 1 (Cycle = 28 days) | Phase 2: PK: Cmax of LOXO-292 (Selpercatinib) |
| Secondary | Phase 1: Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours | Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 hours post dose (cycle length = 28 days) | |
| Secondary | Phase 1: Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) | Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 hours post dose (cycle length = 28 days) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT03157128/registered