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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
Must not have
All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment
Concurrent treatment with systemic cancer-directed therapy including complementary, alternative, herbal, or nutritional supplement-based treatments whose purpose is for anti-cancer effect
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing VK 2019, a new cancer treatment, on patients with a specific type of throat cancer linked to the Epstein-Barr virus who have no other treatment options. The goal is to see if VK 2019 can effectively fight the cancer and to understand its safety and effects on patients.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, confirmed by a test.
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I am not on any other cancer treatments or supplements aimed at fighting cancer.
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I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Response rate
Secondary study objectives
Area under the plasma concentration versus time curve (AUC)
Overall survival
Peak Plasma Concentration (Cmax)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: VK-2019_armExperimental Treatment1 Intervention
Dose escalation and expansion up to 31 additional patients at a maximum of 1800 mg twice 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for carcinoma, particularly those targeting specific molecular pathways or viral associations like VK 2019, include targeted therapies and immunotherapies. Targeted therapies, such as tyrosine kinase inhibitors, work by blocking specific molecules involved in tumor growth and progression.
Immunotherapies, including checkpoint inhibitors, enhance the body's immune response against cancer cells. These treatments are crucial for carcinoma patients as they offer more personalized and potentially more effective options with fewer side effects compared to traditional chemotherapy.
By targeting specific mechanisms, these therapies can improve outcomes and quality of life for patients.
[Expert consensus on ensartinib in the treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer].Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.Potential molecular targets for Ewing's sarcoma therapy.
[Expert consensus on ensartinib in the treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer].Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.Potential molecular targets for Ewing's sarcoma therapy.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,485 Previous Clinical Trials
17,517,272 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,828 Previous Clinical Trials
8,169,630 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,942 Previous Clinical Trials
41,023,416 Total Patients Enrolled
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.