CLINICAL TRIAL

Pevonedistat for Cancer

Locally Advanced
Metastatic
Waitlist Available · 18+ · All Sexes · Houston, TX

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

See full description

About the trial for Cancer

Eligible Conditions
Locally Advanced Malignant Solid Neoplasm · Metastatic Malignant Solid Neoplasm · Unresectable Malignant Solid Neoplasm · Neoplasms

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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Pevonedistat
DRUG
Pembrolizumab
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
Pevonedistat
Not yet FDA approved
Pembrolizumab
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:
If a person's hemoglobin level is below 8 grams per deciliter, they may need a blood transfusion. show original
protein expression Patients with metastatic or locally advanced unresectable solid tumors that have lost expression of all four of the proteins MLH1, PMS2, MSH2, and MSH6 by immunohistochemistry are considered to have dMMR tumors. show original
Albumin > 2.7 g/dL
Total bilirubin =< 1.5 x upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin =< 3 x ULN of the direct bilirubin
The text states that the patients must be at least 18 years old. show original
in 23 of 52 tumours The polymerase chain reaction determined that microsatellite instability was present in more than 30 percent of the microsatellites tested in 23 of 52 tumors. show original
A determination of MSI-H status based on instability at multiple microsatellites, as determined by specific next-generation sequencing panels, is the next generation of testing. show original
Eastern Cooperative Oncology Group (ECOG) performance status 0 means that the cancer patient is able to carry out all self-care activities, and ECOG performance status 1 means that the cancer patient can only carry out some self-care activities. show original
A blood test result shows that the absolute neutrophil count is 1,500/mm^3 or higher. show original
A platelet count of 100,000 or more per cubic millimeter is considered normal. 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: Through study completion, an average of 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: Through study completion, an average of 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Through study completion, an average of 1 year.
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 Pevonedistat will improve 2 primary outcomes and 5 secondary outcomes in patients with Cancer. Measurement will happen over the course of 21 days.

Recommended phase 2 dose of pevonedistat when combined with pembrolizumab (Phase I)
21 DAYS
21 DAYS
Changes in protein misfolding
UP TO 24 WEEKS
Will analyze the pharmacodynamics impact of pevonedistat by evaluating changes in protein misfolding between pre-treatment and on-treatment tumor biopsies.
UP TO 24 WEEKS
Progression free survival (PFS)
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR
Will be assessed by iRECIST v1.1. Will be estimated using the method of Kaplan and Meier.
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR
Objective response (partial response [PR] or complete response [CR]) (Phase II)
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR
Will be assessed by immune modified Response Evaluation Criteria in Solid Tumors (iRECIST) version (v) 1.1.
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR
Duration of response
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR
Incidence of adverse events
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR
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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 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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

What are common treatments for cancer?

Common treatment for cancer involves surgery, chemotherapy, and radiation therapy. The use of hormone therapy and targeted therapies are growing in the treatment of cancer.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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).

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
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