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Trial record 2 of 2 for:    beacon crc

BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment (BERING CRC)

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ClinicalTrials.gov Identifier: NCT04673955
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborators:
iOMEDICO AG
Pierre Fabre Pharma AG
Pierre Fabre Pharma Austria
Information provided by (Responsible Party):
Pierre Fabre Pharma GmbH

Tracking Information
First Submitted Date October 8, 2020
First Posted Date December 17, 2020
Last Update Posted Date December 17, 2020
Actual Study Start Date September 3, 2020
Estimated Primary Completion Date September 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 13, 2020)
Overall Survival [ Time Frame: At 12 months after start of treatment ]
Overall Survival rate
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 13, 2020)
  • Patient and disease profiles at start of treatment with encorafenib plus cetuximab [ Time Frame: Baseline ]
    Demographic and disease chracteristics
  • BRAF-mutation assessment [ Time Frame: Baseline ]
    Date and type of BRAFV600E testing
  • Type and sequence of treatments before and after encorafenib plus cetuximab [ Time Frame: Through study completion, an average of 17 months ]
    Treatment sequence prior to and after encorafenib plus cetuximab
  • Characteristics of treatment with encorafenib plus cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Evaluation of reason for treatment selection (efficacy, safety profile, quality of life, patients preference, physician's preference, comorbidities, other)
  • Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Further Overall Survival parameters
  • Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Best observed tumor response
  • Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Time to progression
  • Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Overall response rate
  • Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Duration of response
  • Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Progression-free-survival
  • Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Disease control rate
  • Effectiveness of treatment with encorafenib and cetuximab [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Duration of disease control
  • Patient reported outcomes during treatment with encorafenib plus cetuximab - evaluated with EORTC QLQ C-30 [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    EORTC QLQ C-30 questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life C-30 questionnaires) to assess quality of life of cancer patients; comprises 30 items, 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea and the financial impact) scales assess symptoms. Only in case of prospective inclusion.
  • Patient's treatment satisfaction - overall [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    4-point scale: very satisfied, satisfied, dissatisfied, very dissatisfied
  • Physician's treatment satisfaction - differentiated by efficiency, safety and overall [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    4-point scale: very satisfied, satisfied, dissatisfied, very dissatisfied
  • Safety and tolerability of treatment with encorafenib and cetuximab - Adverse events and adverse reactions including time to onset and time to resolution [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    Number of patients with Adverse Events and maximum grade per patient, Adverse Drug Reactions, Adverse Drug Reactions grade 3/4, Serious Adverse Events, Serious Adverse Drug Reactions
  • Treatment duration [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    From date to first treatment until date of last treatment (single compounds and whole treatment)
  • Treatment dose intensity [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    From date to first treatment until date of last treatment (single compounds and whole treatment)
  • Number of treatment interruptions [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    From date to first treatment until date of last treatment (single compounds and whole treatment)
  • Duration of treatment interruptions [ Time Frame: Through encorafenib plus cetuximab treatment completion, an average of 9 months ]
    From date to first treatment until date of last treatment (single compounds and whole treatment)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment
Official Title Encorafenib and Cetuximab in Patients With Metastatic, BRAFV600E-mutated, Colorectal Carcinoma: a Multi-centric, Multi-national, Prospective, Longitudinal, Non-interventional Study in Germany and Austria
Brief Summary

The presence of a BRAFV600E mutation is a marker of poor prognosis in patients with mCRC and associated with a median overall survival (mOS) of approximately 12 to 14 months compared to 20 to 25 months for patients with BRAF wild-type tumours. After 1st line therapy, treatment outcomes with standard therapy are poor in patients with BRAF-mutated mCRC, with response rates (ORR) of ≤ 11%, a median progression-free survival (mPFS) between 1.8 and 2.8 months, and a mOS between 4.1 and 6.2 months. Failure to achieve adequate survival outcomes with standard treatment regimens in patients with BRAF-mutated mCRC has encouraged efforts to combine multiple targeted therapies: With 665 randomized patients, the BEACON CRC trial represents the largest trial and is currently the only phase III study in patients with BRAFV600E-mutant mCRC.

BERING CRC - designed as a prospective (allowing initial retrospective documentation), longitudinal, non-interventional study - will investigate the real-world effectiveness, quality of life, safety and tolerability of encorafenib and cetuximab in BRAFV600E-mutant mCRC patients, who have received prior systemic therapy. Data from this study will contribute to a deeper understanding and characterization to the everyday use of encorafenib and cetuximab in a broader patient population in the German and Austrian routine setting.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients with metastatic, BRAFV600E-mutant, colorectal carcinoma, who have received prior systemic therapy, with the decision to receive the doublet therapy encorafenib plus cetuximab according to the current SmPC.
Condition Metastatic Colorectal Carcinoma
Intervention
  • Drug: Encorafenib
    Observation of real-life treatment with encorafenib and cetuximab
  • Drug: Cetuximab
    Observation of real-life treatment with encorafenib and cetuximab
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 13, 2020)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2026
Estimated Primary Completion Date September 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Written informed consent of the patient with regard to the pseudonymized documentation of his/her data in the frame of this non-interventional study
  • Legally capable patient ≥ 18 years of age (no upper limit)
  • Metastatic colorectal carcinoma with BRAFV600E-mutation, pretreated with systemic therapy
  • Decision was taken to treat the patient with the doublet therapy (encorafenib and cetuximab) in accordance with the current SmPC and by prescription; this decision was taken prior to and independent from the inclusion into the study;
  • Treatment with the doublet therapy (encorafenib plus cetuximab) has been started ≤ 3 months prior to providing written informed consent for this study or is planned to be started in the near future.

Exclusion Criteria:

  • More than 2 prior systemic regimens in the metastatic setting (adjuvant systemic therapy with relapse ≤ 6 months will be counted as metastatic treatment line; maintenance treatment will not be counted as separate metastatic treatment line)
  • Prior treatment with any RAF-inhibitor or MEK-inhibitor.
  • Presence of any contraindication with regard to the doublet therapy (encorafenib plus cetuximab) as specified in the corresponding SmPCs
  • Current or upcoming participation in an interventional clinical trial
  • Current or upcoming systemic treatment of any other tumor than metastatic colorectal carcinoma
  • Prisoners or persons who are compulsorily detained (involuntarily incarcerated).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Natalie Mayer, M. Sc. +4976115848 ext 0 natalie.mayer@iomedico.com
Contact: Frank Reichenbach, Dr. rer. nat +4976145261846 ext 0 frank.reichenbach@pierre-fabre.com
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04673955
Other Study ID Numbers NIS-PFO-2020-3101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Pierre Fabre Pharma GmbH
Study Sponsor Pierre Fabre Pharma GmbH
Collaborators
  • iOMEDICO AG
  • Pierre Fabre Pharma AG
  • Pierre Fabre Pharma Austria
Investigators
Study Director: Frank Reichenbach, Dr. rer. nat Pierre Fabre Pharma GmbH
PRS Account Pierre Fabre Pharma GmbH
Verification Date December 2020