CLINICAL TRIAL

TPX-0005 for Cancer

Recruiting · 18+ · All Sexes · Fairfax, VA

This study is evaluating whether a drug called Repotrectinib can be used to treat people with advanced cancer.

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About the trial for Cancer

Eligible Conditions
KRAS Mutation-Related Tumors · Solid Tumors, Advanced Solid Tumors · Solid Metastatic Tumor · Neoplasms

Treatment Groups

This trial involves 2 different treatments. TPX-0005 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 1 & 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.
Trametinib
DRUG
TPX-0005
DRUG
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
Trametinib
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The ECOG performance status is ≤ 1. show original
The article discusses how the RECIST v1.1 criteria can be used to measure disease in solid tumors. show original
This means that people with cancer that has spread to their brain, but who do not have any symptoms, are eligible to participate in this study. show original
Age ≥ 18 (or as required by local regulation).
No more than 3 treatments that are appropriate for the tumor type and stage of disease can be used prior to surgery. show original
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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: Approximately three years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Approximately three 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 TPX-0005 will improve 3 primary outcomes and 8 secondary outcomes in patients with Cancer. Measurement will happen over the course of Up to 24 hours post-dose.

Cmax (maximum plasma concentration) of repotrectinib in combination with trametinib
UP TO 24 HOURS POST-DOSE
Evaluate the maximum plasma concentration of repotrectinib in combination with trametinib
AUC (area under plasma concentration time curve) of repotrectinib in combination with trametinib
UP TO 24 HOURS POST-DOSE
Determine the AUC of repotrectinib in combination with trametinib
Define the Recommended Phase 2 Dose (RP2D)
APPROXIMATELY 22 MONTHS
Determine the preliminary efficacy of repotrectinib in combination with trametinib measured by ORR as assessed per RECIST v1.1
APPROXIMATELY THREE YEARS
Overall survival (OS)
APPROXIMATELY THREE YEARS
Time to response (TTR)
APPROXIMATELY THREE YEARS
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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.

What are common treatments for cancer?

Patients and their family caregivers are asked to identify what treatments are most used or being used for cancer from a list of treatments, and this is then presented to all patients. Some patients receive the option of refusing certain treatments or palliative care, but for the rest of the treatment, the most commonly used treatment is given.

Anonymous Patient Answer

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

There will be nearly 1,800,000 new cancer diagnoses that will be made in the US in 2019 alone. The total estimated number of new cancers a year in the U.S. in 2019 is estimated at 7.5 million cancers.

Anonymous Patient Answer

What is cancer?

Cancer is an illness of the cell that often affects and destroys the cells in the tissue by an immune and/or cytotoxic effect. More than 20 million people will be diagnosed with cancer at some point in their life, and roughly half of cases will be diagnosed during adulthood. We can live forever if diagnosed early and adequately treated. Cancer is now the second leading cause of death in Canada, after heart disease.

Anonymous Patient Answer

What are the signs of cancer?

The most significant symptom of cancer is unexplained weight loss. Other signs include unexplained cough, chest pain, dyspnea, and unexplained fatigue. Other symptoms, such as the cough of pleuritic chest pain are not typically found to be associated with cancer. In patients with signs of malignancy, CT scan is typically ordered. A history of smoking and alcohol consumption should be obtained as well. For patients with unexplained cancer-associated fatigue and weight loss, a diagnosis of inflammatory demyelinating polyneuropathies should be considered. Patients with unexplained neurologic deficit are often found to have leukemia.

Anonymous Patient Answer

What causes cancer?

There are many possible causes of cancer. There is evidence that smoking is the best understood cause. Cancer is a disease of accumulated cellular changes in body cells and the cancer process starts when a mutated gene causes cancer. Some mutations are inherited but most arise in normal cells after some form of stress induces cellular changes in the normal cell DNA.\n\nWhen a cancer starts, there's often a change in the rate of cell division or the way cells divide. The tumor is made up of a group of cells with abnormal cell division that often causes it to invade or spread to other parts of the body. Different types of cancers are caused at different locations at different times. Cancer in the brain occurs in cancer of the neurons in the brain.

Anonymous Patient Answer

Can cancer be cured?

In summary, the research indicates that a cure for most forms of cancer is highly unlikely and this view is supported by the evidence cited.

Anonymous Patient Answer

Have there been any new discoveries for treating cancer?

For the past few decades, cancer treatment has been dominated by radiation and chemotherapy. Recently, we have witnessed more focus and progress in the fields of biology, genetics, genomics, immunology, surgery, and oncology of the disease. It seems that cancer treatment is going in the right direction nowadays but there are still many challenges on how to treat cancer with the best chance of cure. What follows is a look at current developments in cancer treatment that we hope will eventually reach curing cancer.

Anonymous Patient Answer

Is tpx-0005 typically used in combination with any other treatments?

Adding Tpx-0005 does not enhance the anticancer effect of TPM, DT, or RT, and such combinations may not be recommended routinely, if at all, for the treatment of cancer.

Anonymous Patient Answer

Who should consider clinical trials for cancer?

Clinical trials for cancer should be conducted by a clinical oncologist for early phase of the disease as most of the cancers have a favorable response in early phase. Clinical trials can be safely administered by a oncology resident for advanced phase of the disease.

Anonymous Patient Answer

How does tpx-0005 work?

When the tpx-0005 was administered to mice that had been subjected to X-Ray radiation and/or chemical compounds that had a therapeutic effect on the human cancerous cells, these mice seemed to tolerate tpx-0005 better than the individuals who had not had these treatments. The increased number of mature dendritic cells in the lung tissues of the irradiated tpx-0005-treated mice indicates their better ability to reject tumors in those lungs. Data from a recent study encourage further efforts to evaluate tpx-0005's potential role as an immunomodulator in cancer, particularly as a method of reversing immunosuppressive mechanisms in the tumor microenvironment that may lead to enhanced anticancer treatment success.

Anonymous Patient Answer

What does tpx-0005 usually treat?

We were surprised that both breast and colorectal cancers frequently manifest in the lungs. We found that tpx-0005 could treat lung complaints on a regular basis. This treatment is not in its current form.

Anonymous Patient Answer

What is the primary cause of cancer?

Genetic and social factors play a role in causation of cancer. The high prevalence of tobacco, alcohol, and unhealthy diet is due to social factors.

Anonymous Patient Answer
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