Pevonedistat for Cancer
This study is evaluating whether a combination of two drugs may help treat cancer.
See full descriptionAbout the trial for Cancer
Treatment Groups
This trial involves 2 different treatments. Pevonedistat 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.
About The Treatment
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.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Pevonedistat will improve 2 primary outcomes and 5 secondary outcomes in patients with Cancer. Measurement will happen over the course of 21 days.
Patient Q & A Section
What are the signs of cancer?
Findings from a recent study showed that signs of cancer are present much earlier than previously thought in some types of cancer. Some signs are specific to particular cancers, and many of these indications are often present before the onset of symptoms. Other signs are probably found in cancer, but seem not to be associated with any particular form of cancer.
Can cancer be cured?
It is important to understand that no cancer is curable. If we define cure as being undetectable in a patient for a specified amount of time, then there are no curable cancers. If we consider cure as being a cure from all symptomatology, then there is some cure. But we need to be aware that in clinical practice, cure is seldom achieved with any of the many forms of cancer treatment.
How many people get cancer a year in the United States?
around 4 million people are diagnosed with some type of cancer annually in the US. These figures do not necessarily tell the whole story either because they only represent cancer cases that are treated, or they may even omit other types of cancers like non-melanoma skin cancers. The data also can tell us more about cancer in general on several ways; they help us to understand the demographics of cancer, the health disparities between races, and to better understand the reasons behind these disparities.
What causes cancer?
Overall, cancer is caused by environmental factors and genetics. There are several forms of cancer, including cancers of the skin, breast, colon, prostate, brain, and respiratory organs. Genetic syndromes may also contribute to increased risk or decrease efficacy of treatment or increased disease severity.
What is cancer?
Cancer is the general term for tumors that result from abnormal cell growths, which commonly (but not always) originate from abnormal growths in the epithelial cells of tissues and/or organs. Tumors can be malignant or non-malignant. As of July 2009, cancer was the fifth-leading cause of death and the leading cause of cancer-related death in the United States. As of June 2013, there were an estimated 538,940 new cases of cancer. In 2013, it was the second-most-common cause of death among people under 54 years of age, after accidents (8.2% of all fatalities).
What is pevonedistat?
The drug is currently in a Phase I phase II/III clinical trial. In the first-in-human phase IIb study, pevonedistat was evaluated adjuvant to sunitinib in post-prostatectomy prostate cancer patients with positive margins. A partial response was observed with a median PSA decrease of 62.5% (95% CI, -51%; -70%) versus an estimated baseline baseline PSA of 21.9 ng/mL (95% CI, 18.3; -27.7). The drug-associated AEs were predominantly gastrointestinal and, more importantly, there were no new pulmonary and cardiovascular adverse events. In June 2016, the U.S.
What is the average age someone gets cancer?
The most common cancer in U.S. women was breast cancer at 58.7 years. The average age of breast cancer onset was 51.2 years. The most common cancer in males was prostate cancer at 67.2 years. The average age of prostate cancer onset was 59.0 years. The most common cancer in men with a family history was colorectal cancer at 54 years. The average age of colorectal cancer onset was 54.4 years. For children and adolescents, the most common cancer was brain, optic nerve or auditory nerve cancer at 16 years. The average age of children and adolescents with brain cancer was 15.5 years. For young adults, the most common cancer was lung cancer at 25 years.
How does pevonedistat work?
Given its favorable pharmacokinetic and safety profiles, pevonedistat offers a meaningful opportunity to initiate and sustain dosing in cancer patients with poor circulating tumor cells (CTC) counts, and/or to salvage these patients who have failed to achieve durable CTC counts upon platinum-based therapies. ClinicalTrials.gov Identifier: NCT01665067.
Does pevonedistat improve quality of life for those with cancer?
This is the first study to show that pevonedistat treatment improves QOL in metastatic renal cell carcinoma patients. In the long term, studies are underway to explore the applicability of the drug to chemotherapy that has shown a similar impact.
Does cancer run in families?
These data suggest that a familial or genetic basis for prostate cancer is very little more than a hypothesis. However, since many of those affected have relatives with prostate cancer, it is likely that some of these putative genes act in a manner to predispose certain individuals to be diagnosed with prostate cancer.
Has pevonedistat proven to be more effective than a placebo?
In this small, prospective, double-blind, placebo-controlled, pilot trial, there were no significant differences in the efficacy of pebvonedistat 300 mg BID compared with the corresponding dosages administered as a placebo following 4 weeks of treatment at 400 and 800 mg BID. Although the sample size was small, pebvonedistat 300 mg was well tolerated.