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Glutamine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Glutamine and calcium magnesium | EXPERIMENTAL | Glutamine 10g p.o. 3-times a day beginning at day -2 for 7 consecutive days during each chemotherapy cycle. 1g of calcium and 1g of magnesium i.v. over 30 minutes just before the chemotherapy and repeated at the same dose after the completion of the oxaliplatine infusion. All patients will receive an oxaliplatin based chemotherapy with XELOX, FOLFOX-4 or mFOLFOX-6. |
| Calcium magnesium | ACTIVE_COMPARATOR | 1g of calcium and 1g of magnesium i.v. over 30 minutes just before the chemotherapy and repeated at the same dose after the completion of the oxaliplatine infusion. All patients will receive an oxaliplatin based chemotherapy with XELOX, FOLFOX-4 or mFOLFOX-6. |
| Name | Type | Description |
|---|---|---|
| Glutamine | DRUG | Per os |
| Calcium and Magnesium | DRUG | Intravenous |
Inclusion criteria: 1. Histologically- or cytologically- proven adenocarcinoma of the colon or rectum. 2. Disease either in adjuvant or 1st line metastatic setting. 3. Eastern Cooperation Oncology Group (ECOG) performance status inferior or equal to 2. 4. At least 4 weeks following any major surgic...
Glutamine is an investigational small molecule being studied for use in colorectal neoplasms. It is being evaluated for its potential role in preventing oxaliplatin-induced neurotoxicity in patients with these conditions. The drug is currently in Phase 3 clinical development and remains investigational, not yet approved for any use.
Glutamine is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical research to evaluate the drug's safety and efficacy in the oncology setting, specifically for patients with colorectal neoplasms.
Glutamine is in Phase 3 clinical development. This phase involves larger studies to confirm the drug's effectiveness and monitor side effects in a broader patient population. As an investigational drug, Glutamine has not yet received regulatory approval and is still undergoing clinical evaluation.
Glutamine has been studied in a Phase 3 clinical trial registered as NCT01087658, titled "Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity." This completed trial enrolled 200 participants with colorectal neoplasms in Canada. The study was randomized and active-controlled, though it was not double-blind.
Glutamine is the drug name used in the clinical trial context. The compound is a small molecule, and while glutamine is a naturally occurring amino acid, the investigational drug being developed by Sanofi is specifically formulated for therapeutic use in preventing neurotoxicity associated with oxaliplatin treatment in colorectal cancer patients.