Overview
7-ethyl-10-hydroxycamptothecin (SN 38) is a liposomal formulation of the active metabolite of Irinotecan Irinotecan, a chemotherapeutic pro-drug approved for the treatment of advanced colorectal cancer. SN 38 has been used in trials studying the treatment of Cancer, Advanced Solid Tumors, Small Cell Lung Cancer, Metastatic Colorectal Cancer, and Triple Negative Breast Cancer, among others.
Indication
Investigated for use/treatment in colorectal cancer.
Associated Conditions
- Hormone Receptor Positive Metastatic Breast Cancer
- Locally Advanced or Metastatic Urothelial Carcinoma (UC)
- Metastatic Triple Negative Breast Cancers
- Unresectable Triple-Negative Breast Carcinoma
- Metastatic HR Positive, HER2/Neu Negative Breast Cancer
- Unresectable Locally Advanced Triple-negative Breast Cancer
- Unresectable, locally advanced HR Positive, HER2/Neu Negative Breast Cancer
- Unresectable, locally advanced Hormone Receptor Positive Breast Carcinoma
Research Report
SN-38: A Comprehensive Monograph on a Pivotal Topoisomerase I Inhibitor—From Prodrug Metabolite to Advanced Therapeutic Payload
1.0 Introduction: The Re-emergence of a Potent Camptothecin Analog
The history of oncology is marked by the discovery of natural products with profound cytotoxic activity, whose clinical potential was initially hindered by challenging pharmaceutical properties. Few molecules exemplify this narrative better than SN-38 (7-ethyl-10-hydroxycamptothecin). As a semi-synthetic analog of camptothecin, SN-38 belongs to a class of agents that revolutionized cancer treatment by identifying a novel molecular target: DNA topoisomerase I.[1] However, SN-38 is most widely known not as a drug administered to patients, but as the principal active metabolite of irinotecan (CPT-11), a cornerstone chemotherapeutic agent used in the treatment of various solid tumors, most notably metastatic colorectal cancer.[3] The entire therapeutic rationale for administering the water-soluble prodrug irinotecan is to facilitate the
in vivo generation of SN-38, the molecule responsible for virtually all of the desired antitumor effect.[6]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
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2023/09/08 | Phase 2 | Active, not recruiting | |||
2023/06/01 | Phase 2 | Recruiting | |||
2023/05/19 | Phase 1/2 | Recruiting | |||
2023/05/03 | Phase 3 | Active, not recruiting | |||
2023/05/01 | Phase 2 | Recruiting | |||
2023/04/27 | Phase 1 | Recruiting | Shilpa Gupta, MD | ||
2023/03/15 | Phase 2 | Recruiting | |||
2023/01/09 | Phase 2 | Recruiting | |||
2022/11/08 | Phase 3 | Recruiting | |||
2022/10/14 | Phase 2 | Recruiting |
FDA Drug Approvals
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CIMA AEMPS Drug Approvals
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