Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Platinum+ 5-FU · 1 trial · 1 indication
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
| Arm | Type | Description |
|---|---|---|
| Cetuximab Plus Chemotherapy | EXPERIMENTAL | - |
| Chemotherapy alone | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU) | DRUG | Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks |
| Platinum (Cisplatin or Carboplatin) + 5-FU | DRUG | All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks |
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN) * Recurrent and/or metastatic SCCHN, not suitable for local therapy Exclusion Criteria: * Prior systemic chemotherapy, except if given as part of a multimodal treatmen...
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Platinum+ 5-FU is a combination chemotherapy regimen being studied for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck. It was evaluated in the EXTREME trial, which enrolled 442 patients with head and neck cancer.
Platinum+ 5-FU is being developed by Merck KGaA, a German multinational pharmaceutical company. The company's stock is traded under the ticker MKGAF on the OTC market.
Platinum+ 5-FU is in Phase 3 clinical development. The EXTREME trial, which tested this regimen in combination with cetuximab, has been completed. The drug is investigational and not yet approved for use.
Platinum+ 5-FU was studied in the EXTREME trial, registered as NCT00122460. This Phase 3, randomized, active-controlled trial enrolled 442 patients with recurrent or metastatic squamous cell carcinoma of the head and neck across multiple European countries.
No, Platinum+ 5-FU is a chemotherapy regimen consisting of a platinum agent (cisplatin or carboplatin) plus 5-fluorouracil. In the EXTREME trial, it was combined with cetuximab (Erbitux), which is a separate targeted therapy.