Multiple clinical trials spanning Phase 2, Phase 3, and Phase 4 evaluate the therapeutic application and experimental utility of streptozotocin. These completed studies focus on multi-agent therapeutic strategies for advanced malignancies and conditions such as neuroendocrine tumors, islet cell adenoma, Zollinger-Ellison syndrome, adrenocortical carcinoma, and diabetic complications like myocardial infarction. Sponsored by academic institutions, government health organizations such as the National Institute of Diabetes and Digestive and Kidney Diseases, collaborative research groups, and industry partners like Hoffmann-La Roche, all of these trials have reached completed recruitment status.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07083232 | COMPLETED | Diabetic; Myocardial Infarction |
Al-Azhar University |
2024-10-30 | PHASE4 |
| NCT02246127 | COMPLETED | Neuroendocrine Tumors |
Grupo Espanol de Tumores Neuroendocrinos |
2014-10-27 | PHASE3 |
| NCT00448136 | COMPLETED | Neoplasms |
Hoffmann-La Roche |
2007-07 | PHASE2 |
| NCT00094497 | COMPLETED | Carcinoma, Adrenal Cortical |
Collaborative Group for Adrenocortical Carcinoma Treatment |
2004-06 | PHASE3 |
| NCT00001165 | COMPLETED | Islet Cell Adenoma; Neoplasm Metastasis; Zollinger Ellison Syndrome |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
1978-09 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2025-08-14)
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>).