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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease.
The presence of a BRAFV600E mutation is considered a marker of poor prognosis in subjects with mCRC. The preclinical results and preliminary clinical data together justify the evaluation of this triple combination in the first-line setting of this population. The primary objective of the study is to evaluate the antitumor activity of the combination of encorafenib, binimetinib and cetuximab by assessing the overall response rate in adult subjects with previously untreated BRAFV600E-mutant metastatic colorectal cancer. It will also assess the effect of the triple combination on the duration of response, time to response, progression-free survival and overall survival and assess the effect on quality of life. It will also characterize the safety and tolerability of the triple combination as well as describe the pharmacokinetics (PK) of encorafenib, binimetinib, and cetuximab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Arm | Experimental | encorafenib plus binimetinib plus cetuximab |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| encorafenib | Drug | 300 mg administered orally once daily (QD) |
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| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Overall Response Rate (cORR) Based on Local Tumor Assessments | The confirmed overall response rate (cORR) is the percentage of confirmed responses, defined as complete response (CR) or partial response (PR), as assessed by local radiologist/investigator review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR. | From initiation of treatment to disease progression up to a maximum of 17.6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Overall Response Rate (cORR) Based on Central Tumor Assessment | The confirmed overall response rate (cORR) is the percentage of confirmed responses, defined as complete response (CR) or partial response (PR), as assessed by central radiologist review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle KLAUCK, MD | Corporate Medical&Patient/Consumer Division, Pierre Fabre Medicament | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States | ||
| PC dba West Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36763936 | Derived | Van Cutsem E, Taieb J, Yaeger R, Yoshino T, Grothey A, Maiello E, Elez E, Dekervel J, Ross P, Ruiz-Casado A, Graham J, Kato T, Ruffinelli JC, Andre T, Carriere Roussel E, Klauck I, Groc M, Vedovato JC, Tabernero J. ANCHOR CRC: Results From a Single-Arm, Phase II Study of Encorafenib Plus Binimetinib and Cetuximab in Previously Untreated BRAFV600E-Mutant Metastatic Colorectal Cancer. J Clin Oncol. 2023 May 10;41(14):2628-2637. doi: 10.1200/JCO.22.01693. Epub 2023 Feb 10. |
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125 subjects were screened for inclusion in the study. 30 subjects were excluded (29 due to eligibility criteria not met and 1 due to adverse event).
95 subjects were enrolled in the study between 17 January 2019 and 27 December 2019 in 68 investigational centers : 45 in EU, 7 in UK, 10 in USA and 6 in Japan
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| ID | Title | Description |
|---|---|---|
| FG000 | Encorafenib Plus Binimetinib Plus Cetuximab | Encorafenib: 300 mg QD. Binimetinib: 45 mg PO BID. Cetuximab: 400 mg/m2 intravenous (IV) at Cycle 1 day 1 then 250 mg/m2 (IV) every week (QW) for the first 28 weeks. Then, 500mg/m2 IV every two weeks (Q2W) from week 29 (Cycle 8 day 1) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2020 | Jan 10, 2022 |
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All involved know the identity of the intervention assignment.
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| Binimetinib | Drug | Binimetinib 45 mg administered orally twice daily (BID) |
|
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| Cetuximab | Drug | Standard of care for the 28 first weeks(*) and then every 2 weeks (**) : (*) 400 mg/m2 administered as a 120-min infusion on Cycle 1 Day 1, followed by 250 mg/m2 administered as a 60-min infusion once weekly (QW) for the first 28 weeks. (**) 500 mg/m2 administered as a 120-min infusion twice weekly (Q2W) from Week 29 (Cycle 8 Day 1) onward. Following implementation of an Urgent Safety Measure on 26 Mar 2020 due to the outbreak of COVID-19 pandemic, cetuximab infusions could be administered Q2W regardless of the cycle number, after investigator's evaluation of the benefit/risk ratio for the subject, with regards to COVID-19 pandemic. |
|
|
| From initiation of treatment to disease progression up to a maximum of 17.6 months |
| Overall Response Rate (ORR) Based on Local Tumor Assessments | The overall response rate (ORR) is the percentage of responses, defined as complete response (CR) or partial response (PR), as assessed by local radiologist/investigator review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR. | From initiation of treatment to disease progression up to a maximum of 17.6 months |
| Overall Response Rate (ORR) Based on Central Tumor Assessments | The overall response rate (ORR) is the percentage of responses, defined as complete response (CR) or partial response (PR), as assessed by central radiologist review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR. | From initiation of treatment to disease progression up to a maximum of 17.6 months |
| Duration of Response (DOR) Per Local Assessment | Time from first radiographic evidence of response based on local radiologist/investigator review to the earliest documented PD or death due to underlying disease | From first radiographic evidence of response to disease progression up to a maximum of 17.6 months |
| Duration of Response (DOR) Per Central Assessment | Time from first radiographic evidence of response based on central review to the earliest documented PD or death due to underlying disease | From first radiographic evidence of response to disease progression up to a maximum of 17.6 months |
| Time to Response (TTR) Per Local Review | The TTR is defined as the time from the first dose until the first documented radiographic evidence of response of CR or PR per local review | From initiation of treatment to the first radiographic evidence of response up to a maximum of 17.6 months |
| Time to Response (TTR) Per Central Review | The TTR is defined as the time from the first dose until the first documented radiographic evidence of response of CR or PR per central review | From initiation of treatment to the first radiographic evidence of response up to a maximum of 17.6 months |
| Progression-Free Survival (PFS) Per Local Review | Time from first dose to the earliest documented date of disease progression based on local radiologist/investigator review or death due to any cause | From initiation of treatment to disease progression or death up to a maximum of 17.6 months |
| Progression of Free Survival (PFS) Per Central Review | Time from first dose to the earliest documented date of disease progression based on central review or death due to any cause | From initiation of treatment to disease progression or death up to a maximum of 17.6 months |
| Overall Survival (OS) | Time from first dose to death due to any cause | From initiation of treatment to death up to a maximum of 17.6 months |
| Plasma Concentration of Encorafenib | Plasma concentration of encorafenib | 2 hours and 6 hours after dose on Day 1 cycle 1; Predose and 2 hours post dose on Day 1 cycle 2 (cycle length = 28 days) |
| Plasma Concentration of Binimetinib | Plasma concentration of binimetinib | 2 hours and 6 hours after dose on Day 1 cycle 1; Predose and 2 hours post dose on Day 1 cycle 2 (cycle length = 28 days) |
| Plasma Concentration of Cetuximab | Plasma concentration of cetuximab | 2 hours and 6 hours after dose on Day 1 cycle 1; Predose and 2 hours post dose on Day 1 cycle 2 (cycle length = 28 days) |
| Change From Baseline in EORTC QLQ-C30 Over Time | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for cancer subjects (EORTC QLQ-C30) includes a global health status/QoL. The scale ranges in score from 0 to 100, higher score on the global health status/QoL scale indicate higher QoL. Changes from baseline in EORTC QLQ-C30 global health status/quality of life (QoL) over time are presented in this record. | From Cycle 1 Day 1 (C1D1) Visit to the 30-day Safety Follow-up Visit up to a maximum of 17.6 months |
| Change From Baseline in EQ-5D-5L Over Time | The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L VAS records the patient's self-rated health on a vertical visual analogue scale numbered from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine"). Changes from baseline in EQ-5D-5L VAS over time are presented in this record. | From Cycle 1 Day 1 (C1D1) Visit to the 30-day Safety Follow-up Visit up to a maximum of 17.6 months |
| PGIC Scores Over Time | The Patient Global Impression of Change (PGIC) is a measure of patients' perceptions of change in their symptoms over time. For this assessment, subjects answered the following question: "Since starting treatment, my colorectal cancer symptoms are: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse or (7) very much worse." | From Cycle 1 Day 1 (C1D1) Visit to the 30-day Safety Follow-up Visit up to a maximum of 17.6 months |
| Germantown |
| Tennessee |
| 38138 |
| United States |
| Krankenhaus der Barmherzigen Brüder | Vienna | 1020 | Austria |
| UZ Gent, Gastro-Enterology | Ghent | East Flanders | 9000 | Belgium |
| Trial DIO, UZ Gasthuisberg | Leuven | Flemish Brabant | 3000 | Belgium |
| Cliniques universitaires Saint-Luc | Brussels | 1200 | Belgium |
| ICM- VAL d 'Aurelle | Montpellier | Cedex 5 | 34298 | France |
| Hôpital Morvan CHRU de Brest Institut de cancérologie et d'hematologie | Brest | 29200 | France |
| AP-HM CHU Timone | Marseille | 13005 | France |
| Hôpital Cochin Gastroenterology | Paris | 75014 | France |
| Hôpital Europeen Georges Pompidou | Paris | 75015 | France |
| Hôpital Saint Antoine | Paris | 75571 | France |
| HOPITAL HAUT-LEVEQUE, Av de MAGELLAN | Pessac | 33604 | France |
| ICO- Site René Gauducheau | Saint-Herblain | 44805 | France |
| CHU TOULOUSE Rangueil | Toulouse | France |
| IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Foggia | 71013 | Italy |
| Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori | Meldola | Forlì-Cesena | 47014 | Italy |
| Fondazione del Piemonte per l'Oncologia IRCC Candiolo | Candiolo | 10060 | Italy |
| Ospedale Policlinic San Martin | Genova | 16132 | Italy |
| Ospedale S.M. Misericordia | Perugia | 06129 | Italy |
| Pierre Fabre Investigative Site | Nagoya | Aichi-ken | 464-8681 | Japan |
| Pierre Fabre Investigative Site | Kashiwa | Chiba | 277-8577 | Japan |
| Pierre Fabre Investigative Site | Fukuoka | Fukuoka | 811-1395 | Japan |
| Pierre Fabre Investigative Site | Osaka | Osaka | 540-0006 | Japan |
| Pierre Fabre Investigative Site | Nagaizumi-cho | Shizuoka | 411-8777 | Japan |
| Pierre Fabre Investigative Site | Koto-ku, | Tokyo | 135-8550 | Japan |
| St Antonius Ziekenhuis | Utrecht | 3543 AZ | Netherlands |
| Hospital Puerta de Hierro | Madrid | Madrid | 28220 | Spain |
| Complejo Hospitalario De Navarra S Oncologia Medica | Pamplona | Navarre | 31008 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital ClÃnic I Provincial de Barcelona | Barcelona | 08036 | Spain |
| Institut Català d'Oncologia (ICO L'Hospitalet) | Barcelona | 08908 | Spain |
| Hospital de la Santa Creu i Santa Pau | Barcelona | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28009 | Spain |
| Hospital Universitario HM Sanchinarro | Madrid | 28050 | Spain |
| Hospital ClÃnico Universitario de | Valencia | 46010 | Spain |
| Hospital Universitario y Politécnico La FE | Valencia | 46026 | Spain |
| Hospital Alvaro Cunqueiro | Vigo | 36312 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Torbay Hospital, Lowes Bridge | Torquay | Devon | TQ2 7AA | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Sutton | Surrey | SM2 5PT | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| St James Hospital | Leeds | LS9 7TF | United Kingdom |
| GI research team, OHCT, Guy's Hospital | London | SE1 9RT | United Kingdom |
| GI Research Team, The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Arm | encorafenib plus binimetinib plus cetuximab encorafenib: Once daily, orally Binimetinib: Twice daily, orally Cetuximab: Standard of care for the 28 first weeks and then every 2 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary tumor location | The category right-sided/transverse includes "Colon, Right " and "Colon, Transverse" tumor locations". The category left-sided includes "Colon, Left " and "Rectum" tumor locations". | Count of Participants | Participants |
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| Number of metastatic organs | Count of Participants | Participants |
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| ECOG Performance Status | Eastern Cooperative Oncology Group (ECOG) Scale describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. Scale is ranged from 0 to 5 with lower score meaning a lower functional impairment (0 corresponding to "fully active", 5 corresponding to death). | Count of Participants | Participants |
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| Local BRAFV600E mutation result | Count of Participants | Participants |
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| Central BRAFV600E mutation result | Count of Participants | Participants |
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| Metastatic organs | Count of Participants | Participants |
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| Prior antineoplastic therapy setting | Count of Participants | Participants |
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| Prior antineoplastic monotherapy / combination | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Confirmed Overall Response Rate (cORR) Based on Local Tumor Assessments | The confirmed overall response rate (cORR) is the percentage of confirmed responses, defined as complete response (CR) or partial response (PR), as assessed by local radiologist/investigator review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR. | The Efficacy Set (ES) is composed of all included subjects having received at least one dose of study treatment (partial or full) with a centrally confirmed BRAFV600E mutation. | Posted | Number | 95% Confidence Interval | percentage of confirmed responses | From initiation of treatment to disease progression up to a maximum of 17.6 months. |
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| Secondary | Confirmed Overall Response Rate (cORR) Based on Central Tumor Assessment | The confirmed overall response rate (cORR) is the percentage of confirmed responses, defined as complete response (CR) or partial response (PR), as assessed by central radiologist review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR. | The Efficacy Set (ES) is composed of all included subjects having received at least one dose of study treatment (partial or full) with a centrally confirmed BRAFV600E mutation. | Posted | Number | 95% Confidence Interval | percentage of confirmed responses | From initiation of treatment to disease progression up to a maximum of 17.6 months |
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| Secondary | Overall Response Rate (ORR) Based on Local Tumor Assessments | The overall response rate (ORR) is the percentage of responses, defined as complete response (CR) or partial response (PR), as assessed by local radiologist/investigator review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR. | The Efficacy Set (ES) is composed of all included subjects having received at least one dose of study treatment (partial or full) with a centrally confirmed BRAFV600E mutation. | Posted | Number | 95% Confidence Interval | percentage of responses | From initiation of treatment to disease progression up to a maximum of 17.6 months |
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| Secondary | Overall Response Rate (ORR) Based on Central Tumor Assessments | The overall response rate (ORR) is the percentage of responses, defined as complete response (CR) or partial response (PR), as assessed by central radiologist review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR. | The Efficacy Set (ES) is composed of all included subjects having received at least one dose of study treatment (partial or full) with a centrally confirmed BRAFV600E mutation. | Posted | Number | 95% Confidence Interval | percentage of responses | From initiation of treatment to disease progression up to a maximum of 17.6 months |
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| Secondary | Duration of Response (DOR) Per Local Assessment | Time from first radiographic evidence of response based on local radiologist/investigator review to the earliest documented PD or death due to underlying disease | Confirmed responders per local radiologist/investigator assessment | Posted | Median | 95% Confidence Interval | months | From first radiographic evidence of response to disease progression up to a maximum of 17.6 months |
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| Secondary | Duration of Response (DOR) Per Central Assessment | Time from first radiographic evidence of response based on central review to the earliest documented PD or death due to underlying disease | Confirmed responders per central assessment | Posted | Median | 95% Confidence Interval | months | From first radiographic evidence of response to disease progression up to a maximum of 17.6 months |
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| Secondary | Time to Response (TTR) Per Local Review | The TTR is defined as the time from the first dose until the first documented radiographic evidence of response of CR or PR per local review | Confirmed responders per local radiologist/investigator assessment | Posted | Median | 95% Confidence Interval | months | From initiation of treatment to the first radiographic evidence of response up to a maximum of 17.6 months |
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| Secondary | Time to Response (TTR) Per Central Review | The TTR is defined as the time from the first dose until the first documented radiographic evidence of response of CR or PR per central review | Confirmed responders per central assessment | Posted | Median | 95% Confidence Interval | months | From initiation of treatment to the first radiographic evidence of response up to a maximum of 17.6 months |
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| Secondary | Progression-Free Survival (PFS) Per Local Review | Time from first dose to the earliest documented date of disease progression based on local radiologist/investigator review or death due to any cause | The Efficacy Set (ES) is composed of all included subjects having received at least one dose of study treatment (partial or full) with a centrally confirmed BRAFV600E mutation. | Posted | Median | 95% Confidence Interval | months | From initiation of treatment to disease progression or death up to a maximum of 17.6 months |
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| Secondary | Progression of Free Survival (PFS) Per Central Review | Time from first dose to the earliest documented date of disease progression based on central review or death due to any cause | The Efficacy Set (ES) is composed of all included subjects having received at least one dose of study treatment (partial or full) with a centrally confirmed BRAFV600E mutation. | Posted | Median | 95% Confidence Interval | months | From initiation of treatment to disease progression or death up to a maximum of 17.6 months |
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| Secondary | Overall Survival (OS) | Time from first dose to death due to any cause | The Full Analysis Set (FAS) is composed of all subjects having received at least one dose of study treatment (partial or full) | Posted | Median | 95% Confidence Interval | months | From initiation of treatment to death up to a maximum of 17.6 months |
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| Secondary | Plasma Concentration of Encorafenib | Plasma concentration of encorafenib | Not Posted | 2 hours and 6 hours after dose on Day 1 cycle 1; Predose and 2 hours post dose on Day 1 cycle 2 (cycle length = 28 days) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Binimetinib | Plasma concentration of binimetinib | Not Posted | 2 hours and 6 hours after dose on Day 1 cycle 1; Predose and 2 hours post dose on Day 1 cycle 2 (cycle length = 28 days) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Cetuximab | Plasma concentration of cetuximab | Not Posted | 2 hours and 6 hours after dose on Day 1 cycle 1; Predose and 2 hours post dose on Day 1 cycle 2 (cycle length = 28 days) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EORTC QLQ-C30 Over Time | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for cancer subjects (EORTC QLQ-C30) includes a global health status/QoL. The scale ranges in score from 0 to 100, higher score on the global health status/QoL scale indicate higher QoL. Changes from baseline in EORTC QLQ-C30 global health status/quality of life (QoL) over time are presented in this record. | Changes from baseline are shown up to Cycle 10 Day 1 (C10D1) and for the 30-day safety follow-up period. Beyond C10D1, less than 10 subjects filled the questionnaire. Participants analyzed corresponds to the number of participant who completed the questionnaire the at the respective time point. | Posted | Mean | Standard Deviation | units on a scale | From Cycle 1 Day 1 (C1D1) Visit to the 30-day Safety Follow-up Visit up to a maximum of 17.6 months |
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| Secondary | Change From Baseline in EQ-5D-5L Over Time | The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L VAS records the patient's self-rated health on a vertical visual analogue scale numbered from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine"). Changes from baseline in EQ-5D-5L VAS over time are presented in this record. | Changes from baseline are shown up to Cycle 10 Day 1 (C10D1) and for the 30-day safety follow-up period. Beyond C10D1, less than 10 subjects filled the questionnaire. Participants analyzed corresponds to the number of participant who completed the questionnaire the at the respective time point. | Posted | Mean | Standard Deviation | units on a scale | From Cycle 1 Day 1 (C1D1) Visit to the 30-day Safety Follow-up Visit up to a maximum of 17.6 months |
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| Secondary | PGIC Scores Over Time | The Patient Global Impression of Change (PGIC) is a measure of patients' perceptions of change in their symptoms over time. For this assessment, subjects answered the following question: "Since starting treatment, my colorectal cancer symptoms are: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse or (7) very much worse." | PGIC scores are shown up to Cycle 10 Day 1 (C10D1) and for the 30-day safety follow-up period. Beyond C10D1, less than 10 subjects filled the questionnaire. Participants analyzed corresponds to the number of participant who completed the questionnaire the at the respective time point. | Posted | Count of Participants | Participants | From Cycle 1 Day 1 (C1D1) Visit to the 30-day Safety Follow-up Visit up to a maximum of 17.6 months |
|
|
From patient enrolment date to 30 days after the last dose of study drug up to a maximum of 17.6 months
Only treatment emergent Adverse Events are provided in summary tables. A treatment emergent adverse event (TEAE) is defined as any event that first occurred during the treatment period (i.e. from first treatment administration date up to last administration date + 30 days) or that worsened during that study period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Arm | encorafenib plus binimetinib plus cetuximab encorafenib: Once daily, orally Binimetinib: Twice daily, orally Cetuximab: Standard of care for the 28 first weeks and then every 2 weeks | 27 | 95 | 49 | 95 | 93 | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Detachment of retinal pigment epithelium | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders and administration site conditions | MedDRA 23.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders and administration site conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Lymph node tuberculosis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Diversion colitis | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders and administration site conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertrichosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders and administration site conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
The absence of a comparator arm should be noted as a limitation. In addition, the short duration of the follow-up at the data cut-off date does not allow a robust estimate of OS results.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Klauck, MD | Pierre Fabre Medicament | +33149108018 | isabelle.klauck@pierre-fabre.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2021 | Jan 13, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000601108 | encorafenib |
| C581313 | binimetinib |
| D000068818 | Cetuximab |
| 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 |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Belgium |
|
| United States |
|
| Japan |
|
| Italy |
|
| United Kingdom |
|
| France |
|
| Spain |
|
| Other |
|
| >2 |
|
| Indeterminate |
|
| Liver |
|
| Lung |
|
| Lymph node |
|
| Mediastinum |
|
| Ovary |
|
| Peritoneum/Omentum |
|
| Pleural cavity |
|
| Rectum |
|
| Skin |
|
| Stomach |
|
| Other |
|
| Locally advanced |
|
| Oxaliplatin + Capecitabine |
|
| Capecitabine |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Missing, not done |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Missing, not done |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Missing, not done |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Missing, not done |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Missing, not done |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Missing, not done |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Missing, not done |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Missing, not done |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Missing, not done |
|