Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 5-fluorouracil (5-FU)
5-Fluorouracil · 3 trials · 2 indications
PFS time was defined as the time in months from the date of randomization until first observation of PD (based on imaging as assessed by IRC), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 millimeter. PFS was measured using Kaplan-Meier (KM) estimates.
BOR: Percentage of participants experiencing a Complete Response (CR) (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (PR) (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified World Health Organization \[WHO\] criteria), divided by the number of participants belonging to intention to treat (ITT) or safety population.
BOR: Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified WHO criteria), divided by the number of participants belonging to ITT or safety population.
Percentage of participants experiencing a complete response \[CR\] (complete disappearance of measurable and evaluable disease without new lesions) or partial response \[PR\] (greater than or equal to 50 percent decrease in the sum of the products of diameters \[SOPD\] of index lesions compared to the baseline SOPD, with no evidence of PD) confirmed by a subsequent assessment no less than 28 days after criteria for response were first met based on modified WHO criteria as assessed by Independent Review Committee (IRC).
| Arm | Type | Description |
|---|---|---|
| Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil | EXPERIMENTAL | - |
| Cisplatin/Carboplatin + 5-Flurouracil | ACTIVE_COMPARATOR | - |
| Cetuximab + Cisplatin + 5-Fluorouracil (5-FU) | EXPERIMENTAL | - |
| Cetuximab + Cisplatin/Carboplatin + Fluorouracil (5-FU) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cetuximab | DRUG | Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m\^2) on Day 1 and a subsequent dose of 250 mg/m\^2 on Day 8 and Day 15 of each 21-day treatment cycle. |
| Cisplatin/Carboplatin | DRUG | Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m\^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle. |
| 5-fluorouracil | DRUG | Participants received 5-fluorouracil (FU) at a dose of 750 mg/m\^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle. |
| Cisplatin | DRUG | Subjects will receive 75 mg/m\^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle. |
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of SCCHN * Recurrent and/or metastatic SCCHN, not suitable for local-regional treatment * Presence of at least 1 measurable lesion according to RECIST Version 1.1 * Signed written informed consent before any trial-related act...
5-Fluorouracil is used in the treatment of squamous cell carcinoma of the head and neck and metastatic colorectal cancer. It is an oncology small molecule that has been studied in combination with other chemotherapy agents and targeted therapies for these indications.
5-Fluorouracil is a small molecule that interferes with DNA synthesis by inhibiting thymidylate synthase, an enzyme necessary for the production of thymidine nucleotides. This action disrupts cancer cell replication and is used in the treatment of head and neck cancer and metastatic colorectal cancer.
5-Fluorouracil is developed by Merck KGaA, a company traded under the ticker MKGAF. The drug is being investigated in clinical trials for oncology indications, including squamous cell carcinoma of the head and neck and metastatic colorectal cancer.
5-Fluorouracil is in Phase 3 clinical development. It is an investigational drug being studied in completed Phase 3 trials for head and neck cancer and metastatic colorectal cancer. It has not been reported as approved for these indications in the available trial data.
5-Fluorouracil has been studied in completed trials including NCT01177956, a Phase 3 trial in recurrent or metastatic squamous cell carcinoma of the head and neck, and NCT01228734, a Phase 3 trial in metastatic colorectal cancer. These trials evaluated 5-FU in combination with other agents.
Yes, 5-Fluorouracil is also known as 5-FU. The abbreviation 5-FU is commonly used in clinical trial titles and medical literature to refer to the same drug, as seen in trials combining it with cetuximab and other chemotherapy agents.