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Also known as FOLFOX
Modified FOLFOX · 1 trial · 1 indication
Progression-free survival (PFS) was defined as the time from randomization to the earlier of documented disease progression (PD) or death from any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. For patients without measurable disease, PD was defined as an increase in the size of a lesion to one that is measurable or unequivocal progression of a non-target lesion.
| Arm | Type | Description |
|---|---|---|
| Vismodegib 150 mg | EXPERIMENTAL | Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium \[folinic acid\], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium \[folinic acid\] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient. |
| Placebo to vismodegib | PLACEBO_COMPARATOR | Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium \[folinic acid\], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium \[folinic acid\] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient. |
| Name | Type | Description |
|---|---|---|
| Vismodegib 150 mg | DRUG | Vismodegib 150 mg was provided in hard gelatin capsules in 3 different strengths, 25 mg, 125 mg, and 150 mg. |
| Placebo to vismodegib | DRUG | Placebo to vismodegib consisted of the excipients for vismodegib without the active molecule in hard gelatin capsules matching the active drug product in color and size. |
| Bevacizumab | DRUG | Bevacizumab 5 mg/kg was administered intravenously (IV) over 90 minutes for the first infusion, shortening to 60 and 30 minutes for subsequent infusions. |
| Modified FOLFOX | DRUG | Following administration of bevacizumab, patients received oxaliplatin 85 mg/m\^2 IV administered over 90 minutes concurrently with folinic acid 400 mg/m\^2 (d,I-racemic form, or 200 mg/m\^2 I-isomer form) IV administered over 120 minutes, then fluorouracil 400 mg/m\^2 administered as an IV bolus, then 2400 mg/m\^2 administered as a continuous IV infusion over 46 hours. |
| FOLFIRI | DRUG | Following administration of bevacizumab, patients received irinotecan 180 mg/m\^2 IV administered over 90 minutes concurrently with folinic acid 400 mg/m\^2 (d,I-racemic form, or 200 mg/m\^2 I-isomer form) administered IV over 120 minutes, then fluorouracil 400 mg/m\^2 administered as an IV bolus, then fluorouracil 2400 mg/m\^2 administered as a continuous IV infusion over 46 hours. |
Inclusion Criteria: * Age ≥ 18 years * Histologically confirmed metastatic colorectal cancer (CRC) * Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, must be confirmed to be available and requested at any time prior ...
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Modified FOLFOX is a chemotherapy regimen being studied for the treatment of metastatic colorectal cancer. It is a small molecule oncology therapy developed by Roche Holding AG. The drug is currently in Phase 2 clinical development and is considered investigational, meaning it has not yet been approved by regulatory authorities.
Modified FOLFOX is developed by Roche Holding AG, a biopharmaceutical company traded under the ticker RHHBY. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with metastatic colorectal cancer.
Modified FOLFOX is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies. The drug is being studied for the treatment of metastatic colorectal cancer, and its clinical trial has been completed.
Modified FOLFOX has been studied in one completed Phase 2 clinical trial, identified as NCT00636610. This trial enrolled 199 participants and evaluated the drug in combination with concurrent chemotherapy and bevacizumab as first-line therapy for metastatic colorectal cancer. The trial was randomized, double-blind, and placebo-controlled.
Yes, Modified FOLFOX is also known as FOLFOX. The drug is referred to by both names in clinical research. It is being developed by Roche Holding AG for the treatment of metastatic colorectal cancer and is currently in Phase 2 clinical development.
Modified FOLFOX is a chemotherapy regimen that combines multiple small molecule agents to treat metastatic colorectal cancer. The specific molecular targets of the drug have not been disclosed in the available clinical trial information. The drug is being evaluated in combination with other therapies to improve outcomes for patients.