CLINICAL TRIAL

Tepotinib for Colorectal Cancer

Locally Advanced
Metastatic
Waitlist Available · 18+ · All Sexes · Padova, Italy

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

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About the trial for Colorectal Cancer

Treatment Groups

This trial involves 2 different treatments. Tepotinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Tepotinib
DRUG
Cetuximab
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tepotinib
FDA approved
Cetuximab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Less than 2 months between the last administration of the most recent EGFR containing regimen and first dosing in this study
Advanced (locally advanced or metastatic) left sided (from splenic flexure to rectum - National Comprehensive Cancer Network [NCCN] version 4.2020) colorectal cancer (CRC) with RAS/BRAF wild-type at study entry confirmed prior to enrollment, with previous anti-epidermal growth factor receptor (anti-EGFR) therapy and acquired resistance on the most recent anti-EGFR monoclonal antibody therapy (panitumumab or cetuximab) by radiological documentation of disease progression according to RECIST Version 1.1
Mesenchymal epithelial transition (MET) amplification detected by a positive liquid biopsy and/or tissue with appropriate regulatory status (collected after disease progression of the previous anti-EGFR therapy)
Measurable disease by Investigator in accordance with RECIST Version 1.1
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
Life expectancy greater than 3 months
Participants having at least one systemic treatment for mCRC including 1 anti-EGFR monoclonal antibody therapy as the most recent line of therapy for mCRC before study treatment and must have shown a radiologically confirmed by RECIST Version 1.1 complete response (CR) or partial response (PR), both for at least 4 months or stable disease (SD) for at least 6 months to that therapy prior to disease progression
Adequate hematological function, hepatic and renal functions as defined in the protocol
Signed and dated informed consent indicating that the participants had been informed of all the pertinent aspects of the trial prior to enrollment
Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At Day 1 of cycle 1 (each cycle is of 21 days) and at End of Treatment (14 days after last dose, assessed up to 205 days)
Screening: ~3 weeks
Treatment: Varies
Reporting: At Day 1 of cycle 1 (each cycle is of 21 days) and at End of Treatment (14 days after last dose, assessed up to 205 days)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At Day 1 of cycle 1 (each cycle is of 21 days) and at End of Treatment (14 days after last dose, assessed up to 205 days).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Tepotinib will improve 2 primary outcomes and 6 secondary outcomes in patients with Colorectal Cancer. Measurement will happen over the course of Time from first study treatment assessed up to 556 days.

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) Assessed by Investigators
TIME FROM FIRST STUDY TREATMENT ASSESSED UP TO 556 DAYS
TIME FROM FIRST STUDY TREATMENT ASSESSED UP TO 556 DAYS
Overall Survival (OS) Assessed by Investigators
TIME FROM FIRST STUDY TREATMENT ASSESSED UP TO 556 DAYS
TIME FROM FIRST STUDY TREATMENT ASSESSED UP TO 556 DAYS
Number of Participants with Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) Assessed by Investigators
TIME FROM FIRST STUDY TREATMENT ASSESSED UP TO 556 DAYS
TIME FROM FIRST STUDY TREATMENT ASSESSED UP TO 556 DAYS
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) Assessed by Investigators
TIME FROM FIRST STUDY TREATMENT ASSESSED UP TO 556 DAYS
TIME FROM FIRST STUDY TREATMENT ASSESSED UP TO 556 DAYS
Number of Participants with Adverse Events (AEs) and Treatment Related Adverse Events (TRAEs)
TIME FROM FIRST STUDY TREATMENT UP TO 30 DAYS AFTER THE LAST DOSE, ASSESSED UP TO 221 DAYS
TIME FROM FIRST STUDY TREATMENT UP TO 30 DAYS AFTER THE LAST DOSE, ASSESSED UP TO 221 DAYS
Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings
TIME FROM FIRST STUDY TREATMENT UP TO 30 DAYS AFTER THE LAST DOSE, ASSESSED UP TO 221 DAYS
Number of participants with clinically significant changes in vital signs, laboratory parameters and 12-lead ECG will be reported.
TIME FROM FIRST STUDY TREATMENT UP TO 30 DAYS AFTER THE LAST DOSE, ASSESSED UP TO 221 DAYS
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Patient Q & A Section

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

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

Based on a retrospective, population-based dataset, CRC incidence appears to have remained static over the past 5 years in the United States. Incidence rates continue to be higher in blacks than whites, and higher than rates in people with socioeconomic disadvantage. Further studies are needed to confirm these findings, and to assess whether changes in CRC risk factors have contributed to the racial disparity in incidence rates.

Anonymous Patient Answer

What are common treatments for colorectal cancer?

A variety of treatments are prescribed for colorectal cancer patients, with chemotherapy being the most common. Surgery is also widely used, with curative intent in many cases and palliative intent in many others.\n

Anonymous Patient Answer

What is colorectal cancer?

Colorectal cancer is a type of cancer that forms in the large intestine (colon). Most cases of colorectal cancer occur in the small bowel, but it may form in the rectum. It is a disease with some of the highest mortality rates in the UK, with about 5,000 cases per year. It is suspected that colorectal cancer is linked with smoking or diet. It also appears to affect people of all ages.

Anonymous Patient Answer

What causes colorectal cancer?

Cancer in the colon is a disease of aging. The most common cause of [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) in non-smokers are hereditary. Smoking is an important risk factor for colorectal cancer, especially for those who develop the disease at an older age. Women who smoke less than 20 cigarettes per day have a 30% lower risk of colorectal cancer than non-smokers. The risk of colorectal cancer is also increased in those who drink less than 1 beer per day. The greatest risk declines to 10% if one drinks 1.5 beer per day. Eating the same number of vegetables at breakfast and lunch each day may reduce the risk of colorectal cancer by about 30%.

Anonymous Patient Answer

Can colorectal cancer be cured?

Colorectal cancer can be cured within 3.5 years in a significant number of patients, but it is most likely to occur after 3.9 years, which corresponds to a cure rate of 58%-83%.

Anonymous Patient Answer

What are the signs of colorectal cancer?

There are several possible signs of CRC. These include rectal bleeding. Anemia is common as well and most colorectal cancer patients are anemic at time of diagnosis. However, not all CRC patients present with a palpable mass or the typical bloody diarrhea of CRC, but this is more frequent among patients with proximal and sigmoid carcinoma. Any abnormality of stool appearance and consistency should be investigated further with further testing and prompt referrals for medical care.

Anonymous Patient Answer

How does tepotinib work?

We have previously reported that tepotinib inhibits human cell growth through induction of G1 arrest and induction of cell apoptosis in both in vitro and in vivo settings. Here we confirm these antitumor activities, and demonstrate that tepotinib also elicits specific antiproliferative effects in colorectal cancer cells that is not achieved at nontoxic concentrations.

Anonymous Patient Answer

How serious can colorectal cancer be?

Colorectal cancer is a fairly rare but serious disease; it causes a large proportion of deaths in those who are diagnosed with the disease. However, in the past 20 years, colorectal cancer death rates have declined, from over 15 to 7 per 100,000 per year before the year 2000 to around 5 per 100,000 per year in 2008, which suggests that colorectal cancer is being successfully treated. Nevertheless, it would seem that this may not be the case if colorectal cancer is being detected later, which seems to mean that many patients are not being diagnosed with early stage cancer.

Anonymous Patient Answer

What are the latest developments in tepotinib for therapeutic use?

Tepotinib can be regarded as an effective and safe agent for treating patients suffering from non-small-cell lung carcinoma (NSCLC). Tepotinib had a better survival outcome for patients who had tumors with EGFR mutations compared to those without EGFR mutations. Thus, EGFR mutations may be a new biomarker that may serve to select patients with NSCLC who have a better chance for having a better survival time. Findings from a recent study from the first phase II study of tepotinib were encouraging, suggesting that the drug may be effective in treating some other types of cancer, such as colorectal cancer.

Anonymous Patient Answer

Does colorectal cancer run in families?

It would be interesting to replicate these results in other populations, but our results do not necessarily imply that the association observed with the disease in our family is causal. Instead, we suppose that either this cancer is simply more common in that population than in the general population or that these cases would not be diagnosed at all, if the diagnosis were dependent solely on family history which is the only definitive and absolute indicator available today. We are presently looking into other forms of diagnostic procedures such as magnetic resonance imaging to observe whether a cancer has manifested itself elsewhere in the family. It would be interesting to replicate this study comparing different populations across the country, but in the present it does not seem possible at this time.

Anonymous Patient Answer

What are the chances of developing colorectal cancer?

The best way to determine the chances of developing cancer of the colon and rectum is to determine the individual's genotype by genetic testing. Many studies have tried to assess the probability of developing [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer), but none have been as conclusive as they are not accurate in everyone. Most current studies are less than 95% accurate at predicting the chance of developing colorectal cancer. For example, there is only an 88.1% chances of being diagnosed with rectal cancer if one has only one APC mutated gene. This statistic does not take all of the other factors into account.

Anonymous Patient Answer

What is the primary cause of colorectal cancer?

Age is the single most common risk factor for colorectal cancer. Although genetics have a minor, albeit important, role, there is no compelling data implicating the environment as the primary cause of colorectal cancer. However, other studies do suggest the possibility of environmental factors, such as aflatoxin, possibly playing a role in colorectal cancer. Colorectal cancer has a unique pattern of risk. Young men have a higher risk of development of colonic neoplastic lesions because of their increased number of colonocytes. On the other hand, elderly women are more likely than men to present with a curable disease. As a result, colorectal cancer is more likely in males than in females.

Anonymous Patient Answer
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