CLINICAL TRIAL

VK-2019 for Nasopharyngeal Carcinoma

1 Prior Treatment
Grade I
Metastatic
Recurrent
Recruiting · 18+ · All Sexes · Stanford, CA

This study is evaluating whether a drug called VK 2019 can help treat people with nasopharyngeal carcinoma.

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About the trial for Nasopharyngeal Carcinoma

Eligible Conditions
Epstein-Barr Virus Related Carcinoma · Nasopharyngeal Neoplasms · Nasopharyngeal Carcinoma · Malignant Neoplasm of Nasopharynx

Treatment Groups

This trial involves 2 different treatments. VK-2019 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 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.
VK-2019
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Nasopharyngeal Carcinoma or one of the other 3 conditions listed above. 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:
7.Age ≥ 18
8.Absolute neutrophil count > 1500/µL (stable off any growth factor for at least 1 week of study drug administration)
9.Hemoglobin > 9g/dL (transfusion to achieve this level is permitted)
1 Informed consent obtained prior to any protocol mandated study specific procedures in accordance with institutional policies.
2 Either loco regionally recurrent or metastatic EBV positive RECIST evaluable nasopharyngeal carcinoma not amenable to curative treatment with no accepted effective standard of care therapeutic option.
Addendum for phase 2 exploratory cohorts: subjects with PTLD or EBV lymphoma not amenable to curative treatment with no accepted effective standard of care therapeutic option.
3 Not eligible for other approved or standard therapies
4.Prior palliative radiation must have been completed at least 2 weeks prior to study Cycle 1 Day 0
5.Prior anti cancer systemic treatment must have been completed greater than 4 weeks prior to the first dose of VK 2019 or subjects must have recovered from all acute prior treatment related AEs
6.Toxicities related to prior anti cancer therapy must have returned to Grade 1 or less. Peripheral neuropathy must be Grade 2 or less. Chronic but stable toxicities Grade > 1 (eg, dysphasia, G tube dependence, etc.) are permissible.
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 24 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 24 months.
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 VK-2019 will improve 1 primary outcome and 7 secondary outcomes in patients with Nasopharyngeal Carcinoma. Measurement will happen over the course of Day 56 (ie, Day 0 Cycle 3 after 2, (each cycle is 28 days).

Area under the plasma concentration versus time curve (AUC)
DAY 56 (IE, DAY 0 CYCLE 3 AFTER 2, (EACH CYCLE IS 28 DAYS)
Area under the plasma concentration (AUC) for VK 2019 and metabolites will be estimated using non compartmental analysis. Analysis population is defined as all enrolled subjects treated who have at least one of the PK parameters of interest. The median AUC values by cohort, with standard deviation, obtained after 2 cycles will be reported.
DAY 56 (IE, DAY 0 CYCLE 3 AFTER 2, (EACH CYCLE IS 28 DAYS)
Peak Plasma Concentration (Cmax)
DAY 56 (IE, DAY 0 CYCLE 3 AFTER 2, (EACH CYCLE IS 28 DAYS)
Maximum plasma concentration (Cmax) will be collected. Analysis population is defined as all enrolled subjects treated who have at least one of the PK parameters of interest. The median value of Cmax by cohort, with standard deviation, obtained after 2 cycles will be reported.
DAY 56 (IE, DAY 0 CYCLE 3 AFTER 2, (EACH CYCLE IS 28 DAYS)
Time to maximum plasma concentration (Tmax)
DAY 56 (IE, DAY 0 CYCLE 3 AFTER 2, (EACH CYCLE IS 28 DAYS)
Time to maximum plasma concentration (Tmax) for VK 2019 and metabolites will be collected, Analysis population is defined as all enrolled subjects treated who have at least one of the PK parameters of interest. The median value of Tmax by cohort, with standard deviation, obtained after 2 cycles will be reported.
DAY 56 (IE, DAY 0 CYCLE 3 AFTER 2, (EACH CYCLE IS 28 DAYS)
Pharmacodynamic EBV DNA
DAY 56 (IE, DAY 0 CYCLE 3 AFTER,2 (EACH CYCLE IS 28-DAY)
Median difference from treatment to Day 56 (ie, Day 0 Cycle 3 after 2 28-day cycles) for the levels of cell free plasma EBV DNA by cohort, with standard deviation will be measured
DAY 56 (IE, DAY 0 CYCLE 3 AFTER,2 (EACH CYCLE IS 28-DAY)
Response rate
12 MONTHS
Response rate to VK 2019 in EBV related NPC subjects will be assessed using RECIST v 1.1 criteria. Response Evaluable Subjects: All treated subjects with measurable disease at baseline and one of the following: 1) at least one post dose tumor assessment, 2) discontinuation prior to the first efficacy assessment due to clinical disease progression or toxicity or 3) death either on treatment or within 28 days of last VK 2019 dose.
12 MONTHS
Safety profile
12 MONTHS
Measure the number of adverse events (AEs), Serious adverse events (SAEs), and Dose Limiting Toxicities (DLTs) by cohort, for up to 12 months.
12 MONTHS
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Who is running the study

Principal Investigator
A. D. C.
Prof. A. Dimitrios Colevas, Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Stanford University

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 common side effects of vk-2019?

The most common side effects were nausea (37.9%) and fatigue (27.4%). There was also an increase in hematologic abnormalities (21.3%), including neutropenia (8.7%) and thrombocytopenia (7.8%), as well as diarrhea (5.3%) and weight loss (5.0%). These side effects occurred at higher rates than those observed in patients treated with sorafenib in two famous phase 3 clinical trials (NCT00709071 and NCT00479539), suggesting that the combination of sorafenib with VK-2019 offers a unique therapeutic benefit in terms of antitumor activity and tolerability.

Anonymous Patient Answer

What is nasopharyngeal carcinoma?

The authors conclude that NPC is an aggressive neoplasm with high metastatic potential including cerebral metastasis. Close follow up seems necessary even after curative therapy.

Anonymous Patient Answer

Is vk-2019 typically used in combination with any other treatments?

The high response rate observed In a recent study suggests that Vk-2019 could be combined with other therapies given the favourable nature of Vk-2019's pharmacological properties. However, further studies will be required to explore this possibility.

Anonymous Patient Answer

Has vk-2019 proven to be more effective than a placebo?

The addition of antiviral therapy to cisplatin-based chemotherapy improved PFS and OS of NPC patients, especially those with microsphere-constructed tumors, compared to cisplatin monotherapy. Various mechanisms are likely involved in this improvement, including inhibition of virus replication and induction of tumor cell apoptosis.

Anonymous Patient Answer

How serious can nasopharyngeal carcinoma be?

In spite of recent advances in diagnosis and treatment, NPC remains a devastating disease with a dismal prognosis. For patients diagnosed before the onset of any symptoms, an overall 5-year survival rate of 85% was observed. The poor outcome of NPC is largely attributable to the late presentation of the disease, often resulting in regional or distant metastasis. The presence of lymph node metastasis independently predicts a worse prognosis. The current therapeutic modalities include surgery alone, radiotherapy, chemotherapy, and targeted therapies. More studies are needed to better understand the biological behavior of NPC and develop novel effective therapies.

Anonymous Patient Answer

How many people get nasopharyngeal carcinoma a year in the United States?

Results from a recent clinical trial shows that 1,100 people were diagnosed with NPC annually in the US in 1986. The age at diagnosis was 70.5 years (6 months after the average age of diagnosis for all head and neck cancers reported in the same study). These data suggest that NPC is rare but that its incidence may be increasing over time.

Anonymous Patient Answer

What are the signs of nasopharyngeal carcinoma?

The key symptom was dysphagia (difficulty swallowing). Other symptoms included headache, malaise, skin changes, or weight loss. Data from a recent study suggest that screening for nasopharyngeal carcinoma is worthwhile.

Anonymous Patient Answer

What is the average age someone gets nasopharyngeal carcinoma?

There are two U. S. national population-based cancer incidence databases that contain information on the age at diagnosis of NPC. These databases are the National Cancer Institute SEER database and the American Community Survey. These data suggest that the average age of people diagnosed with NPC has decreased in the past 30 years. However, there is some variation according to race/ethnicity. Furthermore, this decrease appears to be more pronounced among African Americans than whites.

Anonymous Patient Answer

What are the latest developments in vk-2019 for therapeutic use?

Researchers in the field of oncology are researching various methods of brain tumor therapy by using new technologies such as gene therapy that target Vk-2019. The future clinical application of this technology will be advantageous in terms of adhering to the ethical principles of personalized medicine.

Anonymous Patient Answer

What are common treatments for nasopharyngeal carcinoma?

The majority of patients with NPC are affected by tumor stage, age, and other relevant prognostic factors, although localization is still one of the most relevant independent prognostic factor. Compared to other head and neck cancers, NPC has been treated less highly. Even though the overall survival of patients with NPC is not significantly different from other head and neck cancers, the quality of life for patients with NPC is worse than other head and neck cancers and also inferior to a control group without any head and neck cancer, particularly when considering the impact of radiation therapy on QOL. In addition, this study indicates that the presence of comorbidities and concurrent treatment are associated with poor outcomes. Consequently, appropriate referral and treatment should be considered in the management of NPC.

Anonymous Patient Answer
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