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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 irinotecan with dabrafenib, cetuximab/panitumumab in the second line of treatment for the potential treatment of colorectal cancer that: has a metastatic, inoperable; has a mutation in the BRAF gene.
Participants in this study will receive one of the following study treatments:
These participants will receive in the second line is irinotecan, dabrafenib + trametinib, cetuximab or panitumumab.
This trial is currently enrolling participants who will receive either irinotecan and dabrafenib plus cetuximab or panitumumab in the second 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 irinotecan in combination with dabrafenib + trametinib and cetuximab or panitumumab in second-line treatment of patients with metastatic inoperable colorectal cancer who have a BRAF mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irinotecan + Dabrafenib + Trametinib and Cetuximab or Panitumumab in the second line of therapy | Experimental | Irinotecan + Dabrafenib + Trametinib and Cetuximab or Panitumumab in the second line of therapy Dabrafenib 150 mg twice orally daily Trametinib 2 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Irinotecan 90 mg/m2 (90-minute IV infusion) weekly. Second-line treatment is administered until disease progression or intolerable toxicity. It may be possible to switch to a regimen of dabrafenib, trametinib, cetuximab or panitumumab if irinotecan is intolerable. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| • Drug: Dabrafenib • Drug: Trametinib • Drug: Cetuximab • Drug: Рanitumumab • Drug: Oxaliplatin • Drug: Irinotecan • Drug: Leucovorin • Drug: 5-FU | Drug | Irinotecan + Dabrafenib + Trametinib and Cetuximab or Panitumumab in the second line of therapy Dabrafenib 150 mg twice orally daily Trametinib 2 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Irinotecan 90 mg/m2 (90-minute IV infusion) weekly. Second-line treatment is administered until disease progression or intolerable toxicity. It may be possible to switch to a regimen of dabrafenib, trametinib, cetuximab or panitumumab if irinotecan is intolerable. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | From date of enrollment until the date of first documented progression | assessed up to 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Moscow | Moscow | 115478 | Russia |
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| OTHER_GOV |
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Time from start of treatment to objective response to treatment
| assessed up to 6 months |
| 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? through study completion, an average of 1 year |
| Overall survival | From the time of enrolment until the death from any cause | assessed up to 36 months |
| Incidence of adverse events | Proportion of patients with adverse events out of all patients (NCI CTCAE 5.0) |
| Incidence of adverse events grade 3-4 | Proportion of patients with adverse events grade 3-4 out of all patients (NCI CTCAE 5.0) |
| Reduction of dose reductions and drug withdrawals | Proportion of patients with dose reductions and drug withdrawals in the total number of patients |
| 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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