Drug intelligence / Profile preview

mitoxantrone hydrochloride liposome + irinotecan + vincristine

Development stage
Unknown
Lead developer
CSPC ZhongQi Pharmaceutical Technology
Modality
Small Molecules
Administration
Intravenous
01

Overview

Mitoxantrone hydrochloride liposome + irinotecan + vincristine (VIM) is a combination chemotherapy regimen being investigated for the treatment of relapsed and refractory solid tumors, particularly in pediatric patients with soft tissue sarcoma. ## Description Mitoxantrone hydrochloride liposome + irinotecan + vincristine (VIM) is a combination chemotherapy regimen that brings together three anticancer agents with different mechanisms of action: 1. **Mitoxantrone hydrochloride liposome**: A liposomal formulation of mitoxantrone, a topoisomerase II inhibitor that intercalates into DNA, causing strand breaks and inhibiting DNA repair. The liposomal encapsulation improves drug delivery to tumor sites while reducing systemic toxicity compared to conventional mitoxantrone. 2. **Irinotecan**: A topoisomerase I inhibitor that prevents DNA from unwinding and replication by inhibiting the religation of DNA strands broken by topoisomerase I. 3. **Vincristine**: A vinca alkaloid that binds to tubulin in mitotic spindles, preventing polymerization into microtubules, thus arresting dividing cells at metaphase. This combination is being studied in clinical trials for pediatric patients with relapsed and refractory solid tumors, particularly soft tissue sarcomas. The regimen is administered intravenously, with mitoxantrone hydrochloride liposome given on day 1, along with vincristine on day 1 and irinotecan on days 1-5 of a 3-week cycle. ## Clinical Development The VIM regimen is currently being evaluated in Phase 2 clinical trials (NCT06514313) where it is being compared to VIT (vincristine + irinotecan + temozolomide) in children with relapsed and refractory soft tissue sarcoma. A Phase 1 dose-escalation study (NCT05620862) has established the maximum tolerated dose (MTD) of mitoxantrone hydrochloride liposome at 24 mg/m² when used in this combination. Preliminary results from clinical trials have shown promising efficacy with an objective response rate of 50% and disease control rate of 90% in pediatric patients with solid tumors, particularly sarcomas. The regimen has demonstrated an acceptable toxicity profile, with the most common adverse events being anemia and diarrhea. ## Canonical name mitoxantrone hydrochloride liposome + irinotecan + vincristine ## Code names VIM ## Brand names [] ## Other names [] ## Description Mitoxantrone hydrochloride liposome + irinotecan + vincristine (VIM) is a combination chemotherapy regimen used in the treatment of relapsed and refractory solid tumors, particularly in pediatric patients with soft tissue sarcoma. This regimen combines three anticancer agents with different mechanisms of action: 1. **Mitoxantrone hydrochloride liposome**: A liposomal formulation of mitoxantrone that acts as a topoisomerase II inhibitor, intercalating into DNA and causing strand breaks. 2. **Irinotecan**: A topoisomerase I inhibitor that prevents DNA unwinding and replication. 3. **Vincristine**: A vinca alkaloid that binds to tubulin, preventing microtubule formation and arresting cell division. The liposomal formulation of mitoxantrone helps reduce bone marrow toxicity compared to conventional mitoxantrone while maintaining efficacy. This combination is administered intravenously in cycles every 3 weeks. ## Developers CSPC Pharmaceutical Group Ltd. ## Manufacturers CSPC Pharmaceutical Group Ltd. ## Is_class false ## Class [] ## Is_dietary_supplement false ## Is_pharmaceutical true ## Is_drug true ## Is_incorrect false ## Is_combination true ## Modalities Small molecule ## Sub_categories [] ## Mechanisms [ { "target_name": "Topoisomerase II", "abbreviation": "Top II", "action_type": "inhibitor" }, { "target_name": "Topoisomerase I", "abbreviation": "Top I", "action_type": "inhibitor" }, { "target_name": "Tubulin", "abbreviation": "", "action_type": "inhibitor" } ] ## Moa_categories ["antineoplastic", "targeted therapy"] ## Broad_active_ingredient [] ## Biosimilar_of [] ## Generic_of [] ## Formulation_of [] ## Contains [ "mitoxantrone hydrochloride liposome", "irinotecan", "vincristine" ] ## Comments The combination is also being compared to VIT (vincristine + irinotecan + temozolomide) in clinical trials for pediatric patients with relapsed and refractory soft tissue sarcoma. ## Development_status { "Soft Tissue Sarcoma": "PHASE2", "Solid Tumors": "PHASE1" } ## Process I analyzed the search results to identify information about the drug combination "mitoxantrone hydrochloride liposome + irinotecan + vincristine" (VIM). I found that this is a combination chemotherapy regimen being studied in clinical trials, particularly for pediatric patients with relapsed and refractory solid tumors, especially soft tissue sarcomas. I identified the mechanisms of action for each component, the developers (CSPC Pharmaceutical Group Ltd.), and the current development status (Phase 2 for soft tissue sarcoma, Phase 1 for solid tumors). I also noted that this combination is being compared to another regimen (VIT) in clinical trials. ## Other_diseases ["Rhabdomyosarcoma"]

02

Targets

TOP1 (DNA Topoisomerase I)TOP2A (DNA topoisomerase II)TUBB (Tubulin (alpha and beta subunits))

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