Several Phase I, Phase I/II, and Phase II clinical trials have evaluated BMS-833923 monotherapy and combination regimens across various oncology indications, including advanced solid tumors, small cell lung carcinoma, stomach and esophageal neoplasms, basal cell carcinoma, basal cell nevoid syndrome, and leukemia. Sponsored by pharmaceutical leaders such as Bristol-Myers Squibb and Exelixis alongside academic centers like the University Health Network, Toronto, these studies assessed safety, pharmacokinetics, and therapeutic activity. Overall, recruitment statuses across these trials are primarily listed as completed or terminated.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT02100371 | COMPLETED | Basal Cell Nevus Syndrome |
University Health Network, Toronto |
2014-02 | |
| NCT01357655 | TERMINATED | Leukemia |
Bristol-Myers Squibb |
2011-09 | PHASE2 |
| NCT00670189 | COMPLETED | Hedgehog Pathway; Smoothened; Basal Cell Carcinoma (BCC); Basal Cell Nevoid Syndrome (BCNS) |
Bristol-Myers Squibb |
2008-07 | PHASE1 |
| NCT01218477 | COMPLETED | Leukemia |
Bristol-Myers Squibb |
2011-01 | PHASE1; PHASE2 |
| NCT01413906 | COMPLETED | Cancer |
Bristol-Myers Squibb |
2011-11 | PHASE1 |
| NCT00909402 | COMPLETED | Stomach Neoplasms; Esophageal Neoplasms |
Bristol-Myers Squibb |
2009-11 | PHASE1 |
| NCT00927875 | COMPLETED | Small Cell Lung Carcinoma |
Bristol-Myers Squibb |
2010-02 | PHASE1 |
| NCT00884546 | COMPLETED | Advanced Cancer, Various, NOS |
Bristol-Myers Squibb |
2009-07 | PHASE1 |
| NCT01413906 | Completed | Cancer |
Bristol-Myers Squibb |
2011-11 | Phase 1 |
| NCT01218477 | Completed | Leukemia |
Bristol-Myers Squibb |
2011-01 | Phase 1|Phase 2 |
| NCT00927875 | Completed | Small Cell Lung Carcinoma |
Bristol-Myers Squibb|Exelixis |
2010-02 | Phase 1 |
| NCT00909402 | Completed | Stomach Neoplasms|Esophageal Neoplasms |
Bristol-Myers Squibb|Exelixis |
2009-11 | Phase 1 |
| NCT00670189 | Completed | Hedgehog Pathway|Smoothened|Basal Cell Carcinoma (BCC)|Basal Cell Nevoid Syndrome (BCNS) |
Bristol-Myers Squibb|Exelixis |
2008-07 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2017-07-11)
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>).