Clinical Trials

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)

Check the BMS-833923 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BMS-833923 acts as a small-molecule antagonist that selectively binds to the Smoothened receptor, blocking downstream signal transduction within the Hedgehog signaling pathway and preventing the activation of Gli family transcription factors. This biochemical blockade reduces aberrant gene transcription and suppresses oncogenic cellular proliferation, thereby inhibiting tumor growth in clinical trial indications such as basal cell carcinoma, small cell lung carcinoma, and esophageal neoplasms.

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>).

Note: Technical data last updated: Sep 1, 2026.