Clinical trial · Interventional
A Study of LY2835219 in Participants With Cancer
Effects of CYP3A Inhibition by Clarithromycin on the Pharmacokinetics of LY2835219 and Its Metabolites in Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess how the body handles Abemaciclib when it is given with another drug called clarithromycin. The study doctor will measure the amount of Abemaciclib that is absorbed into the blood stream and the time that it takes to remove Abemaciclib from the body. The safety and tolerability of these drugs will be studied. Each participant will complete 2 study periods in fixed order. After screening, Period 1 will last approximately 8 days and Period 2 will last approximately 15 days. Participants who complete Period 2 may continue to receive Abemaciclib in 28-day cycles until discontinuation criteria are met.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
| Clarithromycin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Abemaciclib Alone Period 1
- description
- 50 mg single oral dose of Abemaciclib was administered in Period 1 Day 1.
- interventionNames
- Drug: Abemaciclib
- type
- EXPERIMENTAL
- label
- Abemaciclib + Clarithromycin Period 2
- description
- Clarithromycin 500 milligram (mg) orally twice daily for 12 days. Single oral dose of Abemaciclib 50 mg on Period 2 Day 5. Clarithromycin dosing continued for 7 days following the single dose of Abemaciclib.
- interventionNames
- Drug: Abemaciclib
- Drug: Clarithromycin
- type
- EXPERIMENTAL
- label
- Abemaciclib Safety Extension
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have histological or cytological evidence of cancer (solid tumors) that is advanced and/or metastatic * Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale Exclusion Criteria: * No symptomatic central nervous system (CNS) malignancy or metastasis
References
Publications (1)
- DERIVEDGelbert LM, Cai S, Lin X, Sanchez-Martinez C, Del Prado M, Lallena MJ, Torres R, Ajamie RT, Wishart GN, Flack RS, Neubauer BL, Young J, Chan EM, Iversen P, Cronier D, Kreklau E, de Dios A. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014 Oct;32(5):825-37. doi: 10.1007/s10637-014-0120-7. Epub 2014 Jun 13. PMID 24919854