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UFOX+ Cetuximab · 1 trial · 1 indication
Duration from randomization until progression or death due to any cause. Only deaths within 12 weeks of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. Response and progression were assessed by the Investigators using response evaluation criteria in solid tumors (RECIST) 1.0 criteria
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | UFOX + Cetuximab |
| 2 | ACTIVE_COMPARATOR | FOLFOX4 + Cetuximab |
| Name | Type | Description |
|---|---|---|
| UFOX + Cetuximab | DRUG | * Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22) * Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks) * Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21 * Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21 |
| FOLFOX4 + Cetuximab | DRUG | * Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22) * Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks) * 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16 * Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16 |
Inclusion Criteria * Signed written informed consent * Inpatient or outpatient ≥ 18 years of age * Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum * First occurrence of metastatic disease (not curatively resectable) * Presence of at least one lesion measurable uni dimens...
UFOX+ Cetuximab is an investigational combination therapy being studied for the treatment of previously untreated metastatic colorectal cancer. It combines the UFOX regimen with cetuximab. The drug is currently in Phase 2 clinical development and is not approved by regulatory authorities.
UFOX+ Cetuximab is being developed by Merck KGaA, a pharmaceutical company. The company's stock is traded under the ticker symbol MKGAF. The therapy is currently in Phase 2 clinical trials for previously untreated metastatic colorectal cancer.
UFOX+ Cetuximab is in Phase 2 clinical development. It is an investigational therapy for previously untreated metastatic colorectal cancer and has not been approved by regulatory agencies. One Phase 2 clinical trial has been completed to evaluate its efficacy and safety.
UFOX+ Cetuximab has one completed Phase 2 clinical trial registered as NCT00439517. The study, titled 'Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab,' enrolled 302 participants with previously untreated metastatic colorectal cancer across multiple countries.
UFOX+ Cetuximab is a distinct regimen being compared against FOLFOX-4 plus Cetuximab in a clinical trial. The study NCT00439517 evaluates the efficacy and safety of FOLFOX-4 plus Cetuximab versus UFOX plus Cetuximab in patients with previously untreated metastatic colorectal cancer.