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| Name | Class |
|---|---|
| City Clinical Oncology Hospital No 1 | OTHER_GOV |
| Moscow City Oncology Hospital No. 62 | OTHER_GOV |
| The Loginov MCSC MHD | UNKNOWN |
| Moscow Multidisciplinary Clinical Center "Kommunarka" |
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The purpose of this study is to evaluate the efficacy and toxicity of FOLFOX regimen with dabrafenib and cetuximab/panitumumab in the first line of therapy for the potential treatment of colorectal cancer that: has a metastatic, inoperable; has a mutation in the BRAF gene and MSS.
Participants in this study will receive one of the following study treatments:
These participants will receive FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first line of therapy This study is currently enrolling participants who will receive either FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first line of therapy.
The study team will monitor how each participant responds to the study treatment for up to about 3 years.
The purpose of the study is to evaluate the efficacy and toxicity of first-line FOLFOX with dabrafenib and cetuximab or panitumumab in patients with previously untreated metastatic inoperable colorectal cancer who have MSS and BRAF mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy | Experimental | mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy Dabrafenib 150 mg twice orally daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks, Сalcium folinate 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks. In the first-line setting, 8 courses are administered, and if disease control is achieved, dabrafenib, cetuximab or panitumumab therapy is continued until disease progression or intolerable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy | Drug | Dabrafenib 150 mg twice orally daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks, Сalcium folinate 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | From date of enrollment until the date of first documented objective response | assessed at 8 and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first | assessed up to 24 months |
| Time to objective response |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response | Calculated from achieving objective response to progression or death from any cause | assessed up to 12 months |
| Disease control rate | Percentage of patients who achieved a complete response, partial response or disease stabilisation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikhail Fedyanin MD | Contact | +7 905 704-33-18 | fedianinmu@mail.ru | |
| Evgenia Kuzmina MD | Contact | +7 9824012681 | kuz011@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Mikhail Fedyanin MD | Blokhin's Russian Cancer Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blokhin's Russian Cancer Research Center | Recruiting | Moscow | 115193 | Russia |
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| OTHER_GOV |
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|
Time from start of treatment to objective response to treatment
| assessed up to 12 months |
| Overall survival | From the time of enrolment until the death from any cause | assessed up to 36 months |
| through study completion, an average of 1 year |
| Incidence of adverse events | Proportion of patients with adverse events out of all patients (NCI CTCAE 5.0) | through study completion, an average of 1 year |
| Incidence of adverse events grade 3-4 | Proportion of patients with adverse events grade 3-4 out of all patients (NCI CTCAE 5.0) | through study completion, an average of 1 year |
| Frequency of dose reductions and drug withdrawals | Proportion of patients with dose reductions and drug withdrawals in the total number of patients | through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C561627 | dabrafenib |
| D000068818 | Cetuximab |
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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