Encorafenib for Cancer

Phase-Based Estimates
2
Effectiveness
3
Safety
Affiliated Tumor Hospital of Guangxi Medical University, Nanning, China
Cancer+1 More
Encorafenib - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a combination of drugs may help treat colorectal cancer.

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Colorectal Cancer
  • Colorectal Neoplasms

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Encorafenib will improve 2 primary outcomes and 31 secondary outcomes in patients with Cancer. Measurement will happen over the course of Predose on Cycle 1 through Cycle 6. Each cycle is 28 days.

Month 12
Safety Lead-in Study: Incidence of Dose Limiting Toxicities (DLTs)
Safety Lead-in: Duration of response by Investigator
Safety Lead-in: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
Safety Lead-in: Incidence of adverse events
Safety Lead-in: Incidence of dose interruptions, dose modifications and discontinuations due to adverse events
Safety Lead-in: Overall response rate by investigator
Safety Lead-in: Overall survival
Safety Lead-in: Time to response by Investigator
Safety Lead-in:Progression free survival by Investigator
Day 28
Safety Lead-in: Clearance of irinotecan, SN-38 and oxaliplatin
Safety Lead-in: Maximum plasma concentration of encorafenib, LHY746, irinotecan and SN-38
Safety Lead-in: Time to maximim plasma concentration time curve of encorafenib, LHY746, irinotecan and SN-38
Day 28
Safety Lead-in: Area under the plasma concentration time curve of encorafenib, LHY746, irinotecan and SN-38
Day 28
Safety Lead-in: Area under the plasma concentration time curve of encorafenib, LHY746 and oxaliplatin
Safety Lead-in: Maximum plasma concentration of encorafenib, LHY746 and oxaliplatin
Safety Lead-in: Time to maximim plasma concentration time curve of encorafenib, LHY746 and oxaliplatin
Month 34
Phase 3: Change from Baseline in the EuroQol-5D-5L (EQ-5D-5L) Questionnaire
Phase 3: Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Phase 3: Change from Baseline in the Patient Global Impression of Change (PGIC) questionnaires
Phase 3: Change from Baseline in the Patient Global Impression of Severity (PGIS)
Phase 3: Duration of response by blinded independent review and by Investigator
Phase 3: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
Phase 3: Incidence of adverse events
Phase 3: Overall response rate by blinded independent review and by Investigator
Phase 3: Overall survival
Phase 3: Overall survival and Progression free survival by blinded independent review
Phase 3: Progression free survival 2 by Investigator
Phase 3: Progression free survival by Investigator
Phase 3: Progression free survival, by blinded independent review
Phase 3: Time to response by blinded independent review and by Investigator
Once, pre-treatment
Phase 3: Confirm the MSI-status in tumor tissue
Day 28
Phase 3: Determine the correlation between cfDNA genetic alterations and clinical outcome
Day 28
Phase 3: Trough concentrations of encorafenib and its metabolite LHY746

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

5 Treatment Groups

Phase 3 Arm C
Phase 3 Arm A

This trial requires 765 total participants across 5 different treatment groups

This trial involves 5 different treatments. Encorafenib is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Phase 3 Arm AEncorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks
Safety Lead-in Cohort 1Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks Irinotecan 180 mg/m2 (90-minute IV infusion) every two weeks Leucovorin 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
Safety Lead-in Cohort 2Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120 minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks Leucovorin 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
Phase 3 Arm BEncorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120 minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks Leucovorin 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
Phase 3 Arm CEvery two weeks: Oxaliplatin 85 mg/m2 (120-minute IV infusion) Leucovorin 400 mg/m2 (120-minute IV infusion) 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours Bevacizumab (optional; given per prescribing instructions) -OR- Every two weeks: Irinotecan 165 mg/m2 (90-minute IV infusion) Oxaliplatin 85 mg/m2 (120-minute IV infusion) Leucovorin 400 mg/m2 (120-minute IV infusion) 5-FU 2400 or 3200 mg/m2 continuous IV infusion over 46 48 hours Bevacizumab (optional; given per prescribing instructions) -OR- Oxaliplatin 130 mg/m2 (120-minute IV infusion) every 3 weeks Capecitabine 1000 mg/m2 oral tablet twice daily on Days 1-14 Bevacizumab (optional; given per prescribing instructions)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
FDA approved
Encorafenib
FDA approved
Irinotecan
FDA approved
Oxaliplatin
FDA approved
Levoleucovorin
FDA approved
Cetuximab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: duration of phase 3, approximately 34 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly duration of phase 3, approximately 34 months for reporting.

Closest Location

Mayo Clinic - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Cancer or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
This means that the cancer has been confirmed to have the BRAF V600E mutation using a histological or cytological test. show original
If the patient has a relapse or metastasis within six months of finishing adjuvant or neoadjuvant therapy, the treatment is considered to be for metastatic treatment. show original
If you are a male or female aged 18 years or older, you can voluntarily take part in this study. show original
This phase will involve testing of the vaccine in people aged 16 years or older, if permitted by local regulators. show original
ECOG PS 0-1
Adequate organ function
The study population will have measurable or evaluable disease as determined by the investigator. show original
Prior systemic treatment in metastatic setting
SLI: 0-1 regimens
In phase 3, there is no change. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for cancer?

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There is no cure for cancer-related symptoms. Instead, symptomatic treatment is focused on reducing and managing symptoms, and addressing physical, psychological, emotional, and spiritual wellbeing. Common treatments for cancer include surgery, chemotherapy, hormonal therapy, irradiation therapy, hyperbaric oxygen therapy, immunotherapy, targeted therapy, and chemotherapy-stimulating monoclonal antibodies.

Unverified Answer

How many people get cancer a year in the United States?

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There was only a minimal increase in cancer cases when compared to the past 10 years in the United States. This may be due to improvements in the use of cancer treatment in the United States. However, if the rate of increase in cancer cases in the United States is not limited, then it could have devastating effects for cancer patients.

Unverified Answer

What are the signs of cancer?

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For most people with cancer, common signs and symptomatology are quite predictable, and may be elicited easily and reliably (for example, sore/swollen lymph nodes, unexplained weight loss). However, there are a few symptoms of which we cannot tell whether they will occur before or after the cancer has been established, or whether or not there is a causal association. In these circumstances, careful interpretation of the patient's history would be required.

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What is cancer?

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Cancer is a disease that causes abnormal cell growth in the body. People develop cancer to develop cancerous tumors, or cancer cells, in their body such as the breast, urinary bladder, colon, larynx, or skin.\n

Unverified Answer

Can cancer be cured?

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There are no absolute and unequivocal curative regimens for all forms of cancer. However, the current research shows that in many types of cancer there has already been a significant increase in advances in cancer screening (e.g. CT) and therapy (e.g. immunotherapy and targeted therapies). In addition, there are ongoing clinical trials evaluating novel agents to treat the disease. The vast majority of current treatments are aimed at minimizing the burden of symptoms by minimizing or eliminating symptoms rather than cure the disease. Thus, cure is an active and important area for clinical research.

Unverified Answer

What causes cancer?

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It is difficult to identify a single factor causing cancers. Instead, there is a complex interrelationship, including common contributing genotypes, environmental factors, and various dietary components and behaviors.

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What are the chances of developing cancer?

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It is not possible to predict whether a person will develop cancer before the age of 60. Those with an earlier age of onset (beginning of cancer around age 50) or with more than 3 positive family members have a higher risk of developing cancer. People who are obese or have a family history of cancer are at higher risk for developing cancer. Smoking also increases the risk. There were no differences in risk according to lifestyle factors for men or women.

Unverified Answer

What is the survival rate for cancer?

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The prognosis of cancer patients is very different from one cancer to another, and depends on many factors, including the type of cancer and the stage of illness at the start of treatment. Survival can vary drastically if cancer treatments are provided later in life than if treatment is earlier. The survival curves presented in this paper indicate that cancer survival rates are considerably different between countries even if the survival rates in one country are similar to those in another country, for the reason that the patients are treated differently in different countries.

Unverified Answer

How serious can cancer be?

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Cancer is serious insofar as the chance of survival drops to 15%. If we expect this to drop further to 10% or 5% the patient, the physician and the patient start planning treatment and/or considering alternative treatments.

Unverified Answer

What is the primary cause of cancer?

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The most commonly recognized factors associated with increased cancer risk are tobacco and alcohol use, diet, reproductive factors, psychosocial stress, physical inactivity, and other environmental risk factors. However, most patients with cancer report multiple causes for their disease. Even with better understanding of specific tumor sites, specific triggers, and environmental causes, treatment is not effective in curing all patients.

Unverified Answer

Who should consider clinical trials for cancer?

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The current paradigm in cancer practice is that cancer treatments should be assigned based on the individual patient's risk and the clinical trial in question's superiority in that case (or lack of superiority, if there is an equal risk). The rationale for this system appears to be that patients are willing to participate in cancer trials (and, possibly, to risk the inconvenience, inconvenience and even discomfort of treatment, in order to try a more experimental treatment when there is uncertainty about how successful it will be), whereas patients have a stronger barrier against trying treatment that has not been shown to be superior to the existing treatment (especially as that treatment can be very expensive). For this reason, these treatment options are not readily available to most patients, especially outside of the developed countries.

Unverified Answer

Does cancer run in families?

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The familial clustering of breast, colorectal and [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer) in Denmark is suggestive of genetic predisposition to these diseases. Because of methodological drawbacks, no statistical evidence was obtained that cancer susceptibility conferred by a polymorphism on any of the investigated candidate genes was higher in families with familial cancer clustering compared to other Danish families with sporadic cancer.

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