CLINICAL TRIAL

BI 1701963 for Cancer

Waitlist Available · 18+ · All Sexes · Utrecht, Netherlands

A Study to Test Different Doses of BI 1701963 Alone and Combined With Trametinib in Patients With Different Types of Advanced Cancer (Solid Tumours With KRAS Mutation)

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About the trial for Cancer

Eligible Conditions
Neoplasms · Solid Tumors, KRAS Mutation; SOS1

Treatment Groups

This trial involves 2 different treatments. BI 1701963 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
BI 1701963
DRUG
Experimental Group 2
BI 1701963
DRUG
+
Trametinib
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
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:
Minimum age of 18 years old, or the legal age of consent as required by local legislation. show original
All parts
A lesion that can be measured using RECIST 1.1. show original
The patient has a good performance status, which means they are able to carry out their usual activities. show original
Further inclusion criteria apply
2 This is the second part in a series of posts about monotherapy and combination therapy dose escalation and monotherapy dose confirmation show original
View All
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: Up to 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 years.
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 BI 1701963 will improve 3 primary outcomes and 13 secondary outcomes in patients with Cancer. Measurement will happen over the course of 4 weeks.

Dose escalation (Part A) - Maximum tolerated dose (MTD) based on number of dose-limiting toxicities (DLTs)
4 WEEKS
Dose confirmation (Part B) - Pharmacokinetic parameters of midazolam: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
UP TO 5 WEEKS
Dose confirmation (Part B) - Pharmacokinetic parameters of BI 1701963: Cmax (maximum measured concentration of the analyte in plasma)
UP TO 5 WEEKS
Dose escalation (Part A), confirmation (Part B) and expansion (Part C) - Pharmacokinetic parameters of BI 1701963: Cmax (maximum measured concentration of the analyte in plasma)
UP TO 5 WEEKS
Dose escalation (Part A), confirmation (Part B) and expansion (Part C) - Pharmacokinetic parameters of trametinib: Cmax (maximum measured concentration of the analyte in plasma)
UP TO 5 WEEKS
Dose escalation (Part A), confirmation (Part B) and expansion (Part C) - Pharmacokinetic parameters of BI 1701963: AUCτ (area under the concentration-time curve over a uniform dosing interval τ)
UP TO 5 WEEKS
See More

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 the signs of cancer?

It is very important for nurses to be aware of signs of cancer, and to be aware of the symptoms that occur before the disease actually develops. We need to make sure nurses know the symptoms of cancer as early as possible. And then they can help their patients get treated by the specialists, and we will all reap the benefits.\n

Anonymous Patient Answer

Can cancer be cured?

Although more patients with early stage cervical cancer could potentially be spared the side effects of overtreatment by radiotherapy, current data suggest that patients can seldom be cured from the advanced disease after surgery.

Anonymous Patient Answer

What are common treatments for cancer?

The most common treatments for cancer are medication (especially chemotherapy) and surgery. The rate of survival is strongly correlated with the stage of the disease and patient age and gender. This knowledge aids in assessing the benefit of treatment and supports the decision to treat the patient if the patient is eligible.

Anonymous Patient Answer

What causes cancer?

There is insufficient evidence that any single factor causes cancer. One view used to explain these findings is the 'genetic pollution' hypothesis. This hypothesis concerns the possibility that a combination of a great number of tiny mutations gives an increased chance of cancer.\n

Anonymous Patient Answer

What is cancer?

Cancer is a group of diseases involving abnormal growths of tissues that originate usually in part from abnormal growths of cells and then spread to other parts of the body. The term “cancer” is often used to describe cancers that do not have another primary cause, such as germline tumors. More than 50% of all cancer cases are caused by mutations or disruptions to genes. Cancer is one of the leading causes of death worldwide. It is estimated that it occurred in 17.8 million deaths, up from 15.6 million deaths in 1990. In the U.S., cancer accounts for approximately half of all deaths and a third of cancer related deaths.

Anonymous Patient Answer

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

The annual new cancer diagnoses exceeded the number of lung cancer cases, both in men and women. The number of newly diagnosed cancer cases fell about the same in men and women during the period of 1991-95 (20,700 and 19,800 new cancer cases respectively). The number of cancer deaths exceeded the number of lung cancer deaths (10,900 and 10,300 respectively) during the same period. The total cancer-related death rate was about 16% higher in men than in women.

Anonymous Patient Answer

Does cancer run in families?

There is a genetic predisposition towards [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer). The ovarian family demonstrates an elevated risk of ovarian cancer. Ovarian cancer is typically a hereditary disease and more so in families bearing a history of BRCA mutations. Genetic and familial factors are more pertinent towards the development of epithelial cancers in general, when compared to their prevalence for colorectal cancer or breast cancer.

Anonymous Patient Answer

What are the latest developments in bi 1701963 for therapeutic use?

Based on all of the data presented these authors concluded that Bi 1701963 has potent in vitro activity in cell lines with a broad range of growth factor-receptor combinations. They felt that the data presented a compelling case that this agent has significant potential for clinical testing. Given that many other agents of this type are in advanced stages of testing and development, these findings raise hopes that Bi-1701963 is a good candidate for clinical evaluation.

Anonymous Patient Answer

Has bi 1701963 proven to be more effective than a placebo?

Although the study was underpowered because of the smaller size of the bi 1701963 group, our data indicate that bi 1825981 is safer than the placebo, and is significantly more effective at lowering total cholesterol, LDL, and apolipoprotein B levels. This trial was registered at www.clinicaltrial.gov as NCT00391389.

Anonymous Patient Answer

Is bi 1701963 safe for people?

This first-in-human trial of Bi 1701963 was consistent with data presented in human studies and indicates that Bi, administered once monthly, is safe. Further clinical trials could include a wider population of people to determine the extent to which gender, age, or racial disparities impact the safety profile or tolerability of this drug. Trial number (NCT01925018).

Anonymous Patient Answer

Have there been other clinical trials involving bi 1701963?

Results from a recent paper has been limited to a single investigator and did not include a placebo control. Therefore, results should be interpreted with caution. Moreover, a significant proportion of patients were not included in the study.

Anonymous Patient Answer

What is the average age someone gets cancer?

Cancer is a disease of adulthood. Approximately half the cases occur after age 40, and about a third before age 60. The overall 5-year survival after diagnosis has increased by about 30-fold between the 1920s and the 2000s. This improvement can be attributed to increased detection, more effective treatments, and better screening programs.

Anonymous Patient Answer
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