Trial · NCT03157128
A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)
NCT03157128, Phase 1, Phase 2, Active not recruiting, Eli Lilly and Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001). Trials, record NCT03157128. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03157128
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)
- NCT number
- NCT03157128
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 857 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Any Solid Tumor
- Interventions
- LOXO-292
- First posted
- 2017-05-17
- Last updated
- 2026-04-16
- Other registries' IDs
- eudract:2017-000800-59
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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) |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers14
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03157128
GET https://conductscience.org/api/trials/v1/NCT03157128/registered