Multiple clinical trials have evaluated LY2510924 across Phase 1 and Phase 2 studies, exploring its therapeutic potential in advanced solid tumors, leukemia, metastatic clear cell renal cell carcinoma, and extensive-stage small cell lung carcinoma. Sponsored by entities such as Eli Lilly and Company, AstraZeneca, M.D. Anderson Cancer Center, and the High Impact Clinical Research Support Program, these investigations evaluated LY2510924 as monotherapy or combined with chemotherapy or immunotherapy. All trials have reached completed or terminated recruitment statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT02652871 | COMPLETED | Leukemia |
M.D. Anderson Cancer Center |
2016-05-09 | PHASE1 |
| NCT02737072 | TERMINATED | Solid Tumor |
Eli Lilly and Company |
2016-09 | PHASE1 |
| NCT02737072 | Terminated | Solid Tumor |
Eli Lilly and Company|AstraZeneca |
2016-09 | Phase 1 |
| NCT02652871 | Completed | Leukemia |
M.D. Anderson Cancer Center|Eli Lilly and Company|High Impact Clinical Research Support Program |
2016-05-09 | Phase 1 |
| NCT01391130 | TERMINATED | Metastatic Clear Cell Renal Cell Carcinoma |
Eli Lilly and Company |
2011-08 | PHASE2 |
| NCT01439568 | COMPLETED | Extensive Stage Small Cell Lung Carcinoma |
Eli Lilly and Company |
2011-09 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2019-11-15)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).