Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
5-Fluorouracil · 5 trials · 5 indications
A pathologic complete response (pCR) is defined as no pathologic evidence of invasive disease at the primary site in the bowel wall or in examined mesorectal tissue and/or lymph nodes.
| Arm | Type | Description |
|---|---|---|
| Chemoradiotherapy plus Cetuximab | EXPERIMENTAL | Pelvic irradiation plus 5-fluorouracil plus cetuximab |
| Chemoradiotherapy alone | ACTIVE_COMPARATOR | Pelvic irradiation plus 5-fluorouracil |
| Arm 1 | ACTIVE_COMPARATOR | Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322 |
| Arm 2 | ACTIVE_COMPARATOR | Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution) |
| Arm A: Paclitaxel + BMS-906024 | EXPERIMENTAL | Paclitaxel 80 mg/m2 solution and BMS-906024 4 mg or 6 mg solution intravenously once weekly continuously until disease progression or unacceptable toxicity |
| Arm B: FOLFIRI (5FU, Leucovorin, Irinotecan) + BMS-906024 | EXPERIMENTAL | 5FU Bolus 400 mg/m2, 5FU Infusion 2400 mg/m2, Irinotecan 180 mg/m2 solution, Leucovorin 400 mg/m2 solution intravenously once every 2 weeks and BMS- 906024 4 mg or 6 mg solution intravenously once weekly continuously until disease progression or unacceptable toxicity |
| Arm C: Carboplatin/Paclitaxel + BMS-906024 | EXPERIMENTAL | Carboplatin AUC 6 / Paclitaxel 200 mg/m2 solution once every 3 weeks and BMS-906024 4 mg or 6 mg solution once weekly intravenously continuously until disease progression or unacceptable toxicity |
| Arm D: Paclitaxel + BMS-906024 | EXPERIMENTAL | Paclitaxel 80 mg/m2 solution once weekly and BMS-906024 4 mg or 6 mg solution once every 2 weeks intravenously continuously until disease progression or unacceptable toxicity |
| Arm F: Carboplatin/Paclitaxcel and BMS-906024 | EXPERIMENTAL | Carboplatin AUC 6 / Paclitaxel 200 mg/m2 solution once every 3 weeks and BMS-906024 4 mg or 6 mg solution once every 3 weeks intravenously continuously until disease progression or unacceptable toxicity |
| Name | Type | Description |
|---|---|---|
| Cetuximab | DRUG | - |
| 5-fluorouracil | DRUG | - |
| Pelvic irradiation | RADIATION | - |
| Irinotecan | DRUG | Solution, IV, 180 mg/m2, Q14 days, Until PD |
| 5-Fluorouracil (bolus) | DRUG | Solution, IV, 400 mg/m2, Q14 days, Until PD |
| 5-Fluorouracil (infusional) | DRUG | Solution, IV, 2400 mg/m2, Q14 days, Until PD |
| Leucovorin calcium | DRUG | Solution, IV, 400 mg/m2, Q14 days, Until PD |
| CT-322 | DRUG | Solution, IV, 2 mg/kg, Q7 days, Until PD |
| Bevacizumab | DRUG | Solutions, IV, 5 mg/kg, Q14 days, Until PD |
| Bevacizumab Placebo (saline solution) | DRUG | Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD |
| Paclitaxel | DRUG | - |
| Carboplatin | DRUG | - |
| 5-Fluorouracil (5FU) | DRUG | - |
| Leucovorin | DRUG | - |
| BMS-906024 | DRUG | - |
| Docetaxel | DRUG | Given intravenously on day 1 of each 21-day cycle for 3 cycles |
| Cisplatin | DRUG | Intravenously on day 1 of each 21-day cycle for 3 cycles |
Inclusion Criteria: Note: Please see Section 8.1 for the necessary "Prestudy Assessments". A patient will be eligible for inclusion in this study if s/he meets all of the following criteria: * Has a histologically confirmed diagnosis of newly diagnosed adenocarcinoma of the rectum (tumor within 1...
Top 20 of 77 competitors
5-Fluorouracil is a small molecule oncology drug being developed by Bristol-Myers Squibb for the treatment of head and neck neoplasms, rectal cancer, esophagus cancer, colorectal cancer (CRC), and other cancers. It is currently in Phase 1 clinical development as an investigational therapy.
5-Fluorouracil is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various oncology indications.
5-Fluorouracil is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied in combination with other chemotherapy regimens for advanced or metastatic solid tumors.
5-Fluorouracil has been studied in several completed clinical trials, including NCT00193141 for esophageal cancer, NCT00402545 for head and neck cancer, NCT00527111 for rectal cancer, and NCT01653470 for advanced solid tumors. These trials have completed enrollment.
5-Fluorouracil is a small molecule that works by interfering with DNA synthesis in cancer cells. It is a fluorinated pyrimidine analog that inhibits thymidylate synthase, an enzyme essential for DNA replication, thereby slowing or stopping tumor growth.