Approval Probability
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Adjusted LOA
ML Risk
Also known as mFOLFOX6 Regimen
mFOLFOX6 · 2 trials · 2 indications
pCR is defined when no tumor is found on pathology review of the surgical specimen (TRG -0)
Treatment-emergent AEs will be graded according to NCI CTCAE v4.0, vital signs and clinical laboratory
We defined a novel primary endpoint, combining pathological complete response (pCR) rate among operated patients and long-term (≥12 months) clinical complete response (cCR) rate for those electing watchful waiting, into a composite endpoint of modified pCR (mpCR) rate.
Determine activity of 5-Fluorouracil, leucovorin, and oxaliplatin (FOLFOX) plus dasatinib on progression free survival (PFS) in patients with metastatic pancreatic adenocarcinoma
| Arm | Type | Description |
|---|---|---|
| Neoadjuvant Treatment | EXPERIMENTAL | All subjects will receive chemoradiation followed by chemotherapy and nivolumab as neoadjuvant treatment |
| Treatment Arm | EXPERIMENTAL | Dasatinib and mFOLFOX6 |
| Name | Type | Description |
|---|---|---|
| Capecitabine | DRUG | Capecitabine 825 mg/m2 orally twice-daily, 5 days a week for a total of 28 days, given with radiation therapy |
| Radiation therapy | RADIATION | 1.8 Gy/day, 5 days a week for a total of 28 days, given with Capecitabine |
| mFOLFOX6 | DRUG | oxaliplatin 85 mg/m2, leucovorin 400 mg/m2 and fluorouracil 400 mg/m2 IV, fluorouracil 2400 mg/m2 IV (a 46 hrs CI), day 1 of each treatment cycle, every 2 weeks, given with nivolumab |
| Nivolumab | DRUG | Nivolumab 240mg IV, day 1 of each treatment cycle, every two weeks, given with mFOLFOX6 |
| Dasatinib | DRUG | Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle |
Inclusion Criteria: * Signed written IRB approved informed consent * Age ≥ 18 years * ECOG PS 0-1 * Subjects with histologically confirmed primary (non-recurrent) locally advanced rectal adenocarcinoma * Stage T3-4 N0 or TX N+ according to baseline rectal EUS and PET-CT * Patients who are planned f...
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mFOLFOX6 is a chemotherapy regimen used in oncology for the treatment of metastatic pancreatic cancer and rectal cancer. It is being studied in clinical trials for these indications, specifically in combination with other agents such as dasatinib and nivolumab.
mFOLFOX6 is developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical trials to evaluate the regimen in combination with other drugs for pancreatic and rectal cancers.
mFOLFOX6 is in Phase 2 clinical development. It is an investigational regimen and has not been approved by regulatory authorities. Two Phase 2 trials are listed, one completed and one active but not recruiting.
mFOLFOX6 is being evaluated in two Phase 2 trials. NCT01652976 is a completed study of 5-FU, oxaliplatin plus dasatinib in metastatic pancreatic adenocarcinoma with 44 participants. NCT03921684 is an active trial of nivolumab with FOLFOX after chemoradiation in rectal cancer patients with 29 participants.
Yes, mFOLFOX6 is also known as the mFOLFOX6 Regimen. These names refer to the same chemotherapy combination used in the treatment of certain cancers, including metastatic pancreatic cancer and rectal cancer.