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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04673955

Studienbeginn:
September 2020

Letztes Update:
17.12.2020

Wirkstoff:
Encorafenib, Cetuximab

Indikation (Clinical Trials):
Carcinoma, Colorectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Pierre Fabre Pharma GmbH

Collaborator:
iOMEDICO AG, Pierre Fabre Pharma AG, Pierre Fabre Pharma Austria,

Studienleiter

Frank Reichenbach, Dr. rer. nat
Study Director
Pierre Fabre Pharma GmbH

Kontakt

Frank Reichenbach, Dr. rer. nat
Kontakt:
Phone: +4976145261846
E-Mail: frank.reichenbach@pierre-fabre.com
» Kontaktdaten anzeigen

Studienlocations (3 von 12)

Euregio-Brust-Zentrum St.-Antonius-Hospital
Dechant-Deckers-Straße 8
52249 Eschweiler
(Nordrhein-Westfalen)
DeutschlandRekrutierend» Google-Maps
Euregio-Brust-Zentrum St.-Antonius-Hospital
Dechant-Deckers-Straße 8
52249 Eschweiler
(Nordrhein-Westfalen)
DeutschlandRekrutierend» Google-Maps
Private Practice
Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Private Practice
Lübeck
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Private Practice
Offenburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Private Practice
Oldenburg In Holstein
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Private Practice
Schorndorf
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
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Studien-Informationen

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.

Ein-/Ausschlusskriterien

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).

Studien-Rationale

Primary outcome:

1. Overall Survival (Time Frame - At 12 months after start of treatment):
Overall Survival rate



Secondary outcome:

1. Patient and disease profiles at start of treatment with encorafenib plus cetuximab (Time Frame - Baseline):
Demographic and disease chracteristics

2. BRAF-mutation assessment (Time Frame - Baseline):
Date and type of BRAFV600E testing

3. 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

4. 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)

5. Effectiveness of treatment with encorafenib and cetuximab (Time Frame - Through encorafenib plus cetuximab treatment completion, an average of 9 months):
Further Overall Survival parameters

6. Effectiveness of treatment with encorafenib and cetuximab (Time Frame - Through encorafenib plus cetuximab treatment completion, an average of 9 months):
Best observed tumor response

7. Effectiveness of treatment with encorafenib and cetuximab (Time Frame - Through encorafenib plus cetuximab treatment completion, an average of 9 months):
Time to progression

8. Effectiveness of treatment with encorafenib and cetuximab (Time Frame - Through encorafenib plus cetuximab treatment completion, an average of 9 months):
Overall response rate

9. Effectiveness of treatment with encorafenib and cetuximab (Time Frame - Through encorafenib plus cetuximab treatment completion, an average of 9 months):
Duration of response

10. Effectiveness of treatment with encorafenib and cetuximab (Time Frame - Through encorafenib plus cetuximab treatment completion, an average of 9 months):
Progression-free-survival

11. Effectiveness of treatment with encorafenib and cetuximab (Time Frame - Through encorafenib plus cetuximab treatment completion, an average of 9 months):
Disease control rate

12. Effectiveness of treatment with encorafenib and cetuximab (Time Frame - Through encorafenib plus cetuximab treatment completion, an average of 9 months):
Duration of disease control

13. 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.

14. 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

15. 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

16. 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

17. 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)

18. 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)

19. 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)

20. 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)

Geprüfte Regime

  • Encorafenib:
    Observation of real-life treatment with encorafenib and cetuximab
  • Cetuximab:
    Observation of real-life treatment with encorafenib and cetuximab

Quelle: ClinicalTrials.gov


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