Multiple clinical trials sponsored by Eli Lilly and Company have evaluated LY2584702 as a monotherapy or in combination with targeted therapies like erlotinib or everolimus in Phase I and Phase Ib settings. These studies targeted healthy participants and patients with advanced or metastatic solid tumors, non-small cell lung carcinoma, renal cell carcinoma, or neuroendocrine tumors to assess safety, pharmacokinetics, and preliminary efficacy. Recruitment across these early-phase trials has concluded, with final trial statuses documented as either completed or terminated.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT01241461 | COMPLETED | Cancer |
Eli Lilly and Company |
2010-11 | PHASE1 |
| NCT01372085 | COMPLETED | Healthy Participants |
Eli Lilly and Company |
2011-06 | PHASE1 |
| NCT01115803 | TERMINATED | Metastases, Neoplasm; Carcinoma, Non-small Cell Lung; Renal Cell Carcinoma; Neuroendocrine Tumors |
Eli Lilly and Company |
2010-03 | PHASE1 |
| NCT01394003 | TERMINATED | Advanced Cancer |
Eli Lilly and Company |
2008-11 | PHASE1 |
| NCT01241461 | Completed | Cancer |
Eli Lilly and Company |
2010-11 | Phase 1 |
| NCT01115803 | Terminated | Metastases Neoplasm|Carcinoma Non-small Cell Lung|Renal Cell Carcinoma|Neuroendocrine Tumors |
Eli Lilly and Company |
2010-03 | Phase 1 |
| NCT01394003 | Terminated | Advanced Cancer |
Eli Lilly and Company |
2008-11 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2018-08-21)
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>).