NBF-006 for Colorectal Cancer

1
Effectiveness
1
Safety
Next Oncology, San Antonio, TX
Colorectal Cancer+5 More
NBF-006 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Colorectal Cancer

Study Summary

This study is evaluating whether a drug called "mifepristone" may help treat people with a certain type of brain tumor.

See full description

Eligible Conditions

  • Colorectal Cancer
  • Colorectal Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Colorectal Carcinoma (CRC)
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Malignant Neoplasm of Pancreas
  • Lung Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether NBF-006 will improve 1 primary outcome, 3 secondary outcomes, and 2 other outcomes in patients with Colorectal Cancer. Measurement will happen over the course of Change in the incidence and severity of adverse events related to study treatment from baseline to 4 weeks following last dose.

Week 4
Number of patients with treatment-related adverse events as assessed by CTCAE v5.0
Day 30
Best Overall Response per RECIST 1.1
To evaluate correlation between KRAS mutations and clinical outcome
To evaluate correlation between biomarkers and clinical outcome
Day 22
Additional pharmacokinetic parameters for siRNA
Pharmacokinetic parameters for siRNA

Trial Safety

Trial Design

2 Treatment Groups

Control
NBF-006

This trial requires 44 total participants across 2 different treatment groups

This trial involves 2 different treatments. NBF-006 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 and are in the first stage of evaluation with people.

NBF-006
Drug
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 72 hours from start of infusion on cycle 1, day 1 and day 22 and prior to infusion cycle 1, day 8 and cycle 2, day 1
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 72 hours from start of infusion on cycle 1, day 1 and day 22 and prior to infusion cycle 1, day 8 and cycle 2, day 1 for reporting.

Closest Location

Next Oncology - San Antonio, TX

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
The Eastern Cooperative Oncology Group defines a patient's performance status as 0-2 if they are able to carry out all self-care activities and limited physical activity. show original
Patients must have fully recovered from all adverse effects of their previous therapies before starting this study show original
Having adequate bone marrow function means having an ANC of at least 1.5 x 109/L and a platelet count of at least 100 x 109/L. show original
All female patients of childbearing potential must have a negative serum or urine pregnancy test result at the time of pre-treatment screening. show original
Patients who have histologically or cytologically confirmed progressive or metastatic NSCLC, pancreatic, or colorectal cancer, and have failed standard treatment are eligible for treatment with Keytruda show original
Patients with NSCLC that has spread and is getting worse, and that has a KRAS-mutant gene, may be eligible for this study show original
You must have adequate renal function, defined as a serum creatinine level that is less than the upper limit of normal for your institution, or a calculated creatinine clearance using the Cockcroft-Gault method, of at least 60 mL/min/1.73 m² show original
People with adequate hepatic function have total bilirubin levels that are lower than 1.5 mg/dL and alanine transaminase (ALT) and aspartate transaminase (AST) levels that are lower than 2.5 times the upper limit of normal (ULN), or lower than 5 times the ULN if they have known liver metastases. show original
Patients who may become pregnant must use birth control while taking the study drug and for up to one month after stopping the study drug. show original
Men and women ≥ 18 years of age.

Patient Q&A Section

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

Does nbf-006 improve quality of life for those with colorectal cancer?

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This pilot study adds to the evidence that Nbf-006 is safe and achieves improvements in quality of life and physical function at both 6 and 12 weeks. The observed improvements in all aspects of health-related quality of life represent a meaningful improvement in QoL.

Unverified Answer

What is colorectal cancer?

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The majority of colon and rectal cancers are adenocarcinomas. As the most frequently diagnosed tumors of the colon or rectum, they are associated with frequent and early stage disease. In the future, screening colonoscopy and imaging may replace colon biopsies as the primary method of diagnosis.

Unverified Answer

What are common treatments for colorectal cancer?

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The treatment given depends upon which stage a patient is at, how well the person is, and the patient's general health; and may also be influenced by the surgeon's preference, the type of hospital a person is in, and the person's preference. For all people, there are a number of approaches including surgery, radiation, endoscopic or open surgery, radiation therapy, chemotherapy, or hormonal therapy.

Unverified Answer

What causes colorectal cancer?

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There is still a large difference in the incidence of colorectal cancer and its risk factors among different countries and regions, especially between different regions of Europe. Even among countries or regions with similar population density, colorectal cancer incidence rates and mortality rates vary considerably, suggesting significant differences in colorectal cancer biology. There is a huge variation in colorectal cancer mortality due to differences in socioeconomic status and access to clinical service throughout the globe.

Unverified Answer

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

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Approximately 1.2 million people die of colorectal cancer annually. About 1 in 3 are diagnosed with the illness. Men are most commonly diagnosed (61%), and women are primarily attributed to the mortality (53%). Older patients have higher rates of colorectal cancer occurrence. Those diagnosed with stage II were significantly more likely to perish (relative mortality: 0.6). Colorectal cancer screening in women who are younger than 50 and in specific groups of men is warranted.

Unverified Answer

What are the signs of colorectal cancer?

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For most patients with colorectal cancer, signs of early disease are not identifiable by colonoscopy or sigmoidoscopy. Colonic bleeding in the absence of a known mucosal lesion or colonoscopy can be one indicator of colorectal cancer. However colonoscopy and sigmoidoscopy can detect colonoscopic adenoma. The presence of two or more adenomas on colonoscopy increases the sensitivity from 58 to 87% with a concurrent rectoscopy.

Unverified Answer

Can colorectal cancer be cured?

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Surgical removal of the rectal tumor and an end-to-end anastomosis is the most successful method for cure of patients with rectal adenocarcinoma. Preoperative chemoradiotherapy is used in our centers in selected patients to reduce tumor size in order to achieve sphincteric preservation and to allow neoadjuvant treatment prior to surgery. If the preoperative radiation and surgery techniques fail to completely obliterate the tumor, and patients have had a preoperative embolization or lymphadenectomy, the postoperative chemotherapy is not typically effective in altering survival.

Unverified Answer

Have there been other clinical trials involving nbf-006?

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There have only been two similar clinical trials in [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer). These two study Nbf-006: NCT00689716 and NCT00689717. Both of these trials show a decrease in cancer by 50%. Since Nbf-006 showed no toxicities, a longer study is needed.

Unverified Answer

What are the chances of developing colorectal cancer?

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In our population, approximately 1 in 500 men and in 1 in 1000 women are expected to develop CRC. These figures are relatively consistent across different populations within North America. However, the actual numbers will be higher in populations from different parts of the world, because not all CRC is diagnosed or treated. Therefore, actual numbers are expected to be higher than our predictions.

Unverified Answer

Have there been any new discoveries for treating colorectal cancer?

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There have been many new discoveries over the past 20 years. While they are invaluable for understanding of carcinogenesis, current medical oncologists are still struggling to find a cure for colorectal cancer, and have begun researching alternative treatments. Although there is no evidence for colorectal cancer being contagious, some research is being conducted to determine if a combination of some alternative treatments can help prevent colorectal cancer in family members, with the goal of finding something for the gene mutation carriers to be able to do. In order to develop a treatment for Colorectal cancer, it is necessary for the medical community to conduct research so that alternative methods, such as medical foods, can be found.

Unverified Answer

What is nbf-006?

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Nbf-006 was found to increase apoptotic activity in peripheral blood mononuclear cells. When administered alone, no clinical benefit was seen in patients. When combined with metronomic chemotherapy, a small but significant increase in progression-free time was noted.

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What are the common side effects of nbf-006?

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As for most new drugs, it is unknown when to first discontinue therapy. Patients should monitor themselves for some unusual side effects of nbf-006 but there is no evidence that they are fatal. Nbf-006 was well tolerated in a phase 3 study. Serious toxicity was not seen although the drug is thought to be embryotoxic in animals.

Unverified Answer
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