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Small Molecule
VK-2019 for Nasopharyngeal Cancer
Phase 2
Recruiting
Led By A. Dimitrios Colevas
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18
Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new drug for people with a certain type of cancer for whom there is no other standard treatment available.
Who is the study for?
Adults with EBV-positive nasopharyngeal cancer not eligible for standard treatments can join. They must have good kidney function, controlled protein in urine, agree to birth control use, and be generally well enough (ECOG ≤2). Prior treatments should be completed with recovered side effects (except stable chronic issues), and blood counts need to meet specific levels.Check my eligibility
What is being tested?
The trial is testing VK-2019's effectiveness against EBV-related nasopharyngeal carcinoma when no other treatment options are available. It includes pharmacokinetic and pharmacodynamic studies to understand how the drug behaves in the body and its biological effects.See study design
What are the potential side effects?
Specific side effects of VK-2019 aren't listed but may include typical reactions such as fatigue, nausea, liver enzyme changes, or allergic responses. Side effects will be monitored closely throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can do most of my daily activities on my own.
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I am not eligible for any other standard cancer treatments.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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My nasopharyngeal cancer cannot be cured, has spread, and lacks standard treatment options.
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My lymphoma cannot be cured with standard treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC)
Overall survival
Peak Plasma Concentration (Cmax)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: VK-2019_armExperimental Treatment1 Intervention
1800 mg VK 2019 once daily, cycles will be defined as 28 days of treatment, subjects will receive VK 2019 until progression or dose limiting toxicity, for up to 12 cycles.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
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National Cancer Institute (NCI)NIH
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National Institutes of Health (NIH)NIH
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, confirmed by a test.I am HIV positive but have a stable condition with effective treatment, no opportunistic infections, a CD4 count above 250, and an undetectable viral load.My white blood cell count is healthy without medication.My urine protein levels are low, under 1g/24 hours if tested with a 24-hour collection.I haven't had serious heart or lung issues in the past year.I don't have any serious illnesses or infections that would stop me from safely receiving treatment.I have not had certain treatments before.I am 18 years old or older.I can do most of my daily activities on my own.I finished my last cancer treatment over 4 weeks ago or have recovered from its side effects.I finished any palliative radiation at least 2 weeks ago.I am not eligible for any other standard cancer treatments.My hemoglobin level is above 9g/dL, transfusions are okay.My kidney function, measured by creatinine levels or clearance, is within the required range.I am not on any other cancer treatments or supplements aimed at fighting cancer.My nasopharyngeal cancer cannot be cured, has spread, and lacks standard treatment options.My lymphoma cannot be cured with standard treatments.I am not pregnant or breastfeeding.My cancer has spread to my brain but is stable after radiation treatment.Side effects from my previous cancer treatments are mild or gone, except for some stable long-term effects.
Research Study Groups:
This trial has the following groups:- Group 1: VK-2019_arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do you have any available appointments for this treatment?
"Yes, this information is accurate. According to the clinicaltrials.gov website, this study was posted on 1/25/2022 and updated on 3/31/2022. The study is still recruiting patients at this time."
Answered by AI
What is the official regulatory stance on VK-2019?
"Since this is a phase 2 trial, meaning that while there is some safety data, there is no efficacy data, we have scored VK-2019 as a 2 in terms of safety."
Answered by AI
How many people have enrolled in this trial thus far?
"That is correct, the listing on clinicaltrials.gov currently states that this research project is open to enrolling patients. This trial was first made public on January 25th, 2022 and has been updated as recently as March 31st, 2022. So far, 30 individuals have signed up at a single location."
Answered by AI
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