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Arm NaI-IRI+ 5-FU+ Leucovorin · 1 trial · 7 indications
| Arm | Type | Description |
|---|---|---|
| Arm NaI-IRI + 5-FU + Leucovorin (Arm A) | EXPERIMENTAL | Nal-IRI \[Irinotecan liposome\], 5-FU \[5-Fluorouracil\], Leucovorin Cycle q2w |
| Arm Cisplatin + Gemcitabine (Arm B, standard of care) | OTHER | Cisplatin, Gemcitabine Cycle q3w |
| Name | Type | Description |
|---|---|---|
| Arm NaI-IRI + 5-FU + Leucovorin (Arm A) | DRUG | Nal-IRI (80 mg/m2 as a 1.5 hour infusion), 5-FU (2400 mg/m2 as 46 hour infusion) and Leucovorin (400 mg/m2 as 0.5 hour infusion) Cycle q2w |
| Arm Cisplatin + Gemcitabine (Arm B) | DRUG | Cisplatin (25 mg/m2 as 1 hour infusion on D1, D8) and Gemcitabine (1000 mg/m2 as 0.5 hour infusion on D1, D8) Cycle q3w |
Inclusion Criteria: 1. Written informed consent incl. participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations 2. Age ≥ 18 years...
Arm NaI-IRI+ 5-FU+ Leucovorin is a treatment regimen being studied for metastatic adenocarcinoma, including biliary tract cancer. It combines nal-IRI with 5-fluorouracil and leucovorin. The regimen is under investigation in a Phase 2 clinical trial for patients with advanced biliary tract cancers and related conditions.
Arm NaI-IRI+ 5-FU+ Leucovorin is being developed by Tango Therapeutics, Inc. (NASDAQ: TNGX). The company is conducting clinical research on this combination regimen for the treatment of metastatic adenocarcinoma and biliary tract cancer.
Arm NaI-IRI+ 5-FU+ Leucovorin is in Phase 2 clinical development. It is an investigational regimen, not yet approved by regulatory authorities. The Phase 2 trial has been completed, with results expected to inform further development.
Arm NaI-IRI+ 5-FU+ Leucovorin was studied in clinical trial NCT03044587, a Phase 2 study titled 'Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer.' The trial enrolled 93 participants and has been completed.
Yes, Arm NaI-IRI+ 5-FU+ Leucovorin refers to the combination of nal-IRI (liposomal irinotecan) with 5-fluorouracil and leucovorin. This regimen was evaluated in the clinical trial NCT03044587 for advanced biliary tract cancer and metastatic adenocarcinoma.