Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Liposomal Irinotecan · 1 trial · 1 indication
To compare the progression free survival
Number of participants with treatment-related Neurotoxicity according to CTCAE v4.0
| Arm | Type | Description |
|---|---|---|
| Liposomal irinotecan, leucovorin and 5FU | EXPERIMENTAL | IV Nal-IRI 80 mg/m² (expressed as irinotecan hydrochloride (HCl) salt), folinic acid 400 mg/m², fluorouracil 2400 mg/m² over 46 h, every 2 weeks. No addition of nivolumab is possible for this arm |
| Carboplatin and capecitabine | EXPERIMENTAL | IV and PO Capecitabine 1000 mg/m2 and carboplatin area under the curve (AUC5), every three weeks. In case of PD-L1 CPS ≥5 only: nivolumab, dose according to local standard, iv day 1 |
| oxaliplatin and capecitabine | EXPERIMENTAL | IV and PO Capecitabine 1000 mg/m2 and oxaliplatin 130 mg/m2, every three weeks. In case of PD-L1 CPS ≥5 only: nivolumab, dose according to local standard, iv day 1 |
| Name | Type | Description |
|---|---|---|
| Liposomal Irinotecan | DRUG | Iv liposomal irinotecan |
| Carboplatin | DRUG | IV Carboplatin |
| Capecitabine | DRUG | PO Capecitabine |
| Oxaliplatin | DRUG | IV Oxaliplatin |
| 5-fluorouracil | DRUG | IV 5-fluorouracil |
| Leucovorin | DRUG | IV Leucovorin |
Inclusion Criteria: * Patients must provide written informed consent according to International Conference on Harmonization (ICH)/Guideline for Good Clinical practice (GCP), and national/local regulations prior to any screening procedures. * Male or female adult patients (\> 18 years). * Patients w...
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Liposomal Irinotecan is an investigational small molecule being studied for the treatment of esophageal cancer. It is currently in Phase 2 clinical development. The drug is being evaluated in a randomized, controlled trial to assess its efficacy and safety in patients with this condition.
Liposomal Irinotecan is a topoisomerase I inhibitor. It works by inhibiting the enzyme topoisomerase I, which is involved in DNA replication, thereby interfering with cancer cell growth and division. This mechanism is being studied in the context of esophageal cancer.
Liposomal Irinotecan is being developed by Tango Therapeutics, Inc. (NASDAQ: TNGX). The company is conducting clinical trials to evaluate the drug's potential as a treatment for esophageal cancer.
Liposomal Irinotecan is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants.
Liposomal Irinotecan is being studied in a Phase 2 clinical trial with the identifier NCT03764553. This trial, titled 'Liposomal iRInotecan, Carboplatin or oXaliplatin for Esophagogastric Cancer,' is a randomized, controlled study with an estimated enrollment of 320 participants. The trial is being conducted in the Netherlands.
Liposomal Irinotecan is a liposomal formulation of irinotecan, meaning the drug is encapsulated in liposomes to potentially alter its delivery and distribution in the body. While it contains the same active ingredient, the liposomal formulation distinguishes it from standard irinotecan.