Advanced Stage Cancer (Solid Tumor Disease for 4 Patients)NCT03420430
Expanded Access to Provide GL-ONC1 for the Treatment of Advanced Cancers With No Standard of Care
A study testing GL-ONC1 in people with Advanced Stage Cancer (Solid Tumor Disease for 4 Patients) and Acute Myeloid Leukemia (6 Patients), run by Genelux Corporation at 1 site in United States.
Trial summary
GL-ONC1 expanded access is for patients who are ineligible for an ongoing GL-ONC1 clinical trial. Expanded access is intended to treat individual patients with advanced stage cancers, including blood cancer, with no standard of care options for treatment. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Advanced Stage Cancer (Solid Tumor Disease for 4 Patients), Acute Myeloid Leukemia (6 Patients)
- What is being tested?
- GL-ONC1
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Diagnosis of advanced cancers with no standard of care option for treatment.
- Willing and able to provide written, signed informed consent.
- Use of adequate contraception.
- Negative pregnancy test.
Who cannot join
- Have not recovered from severe adverse events from prior therapy.
- Major surgery occurred within 28 days prior to treatment.
- Known immune system disorders such as HIV, or active hepatitis B or C infection.
- Clinically significant cardiac disease (New York Heart Association Class III or IV).
- Have received prior therapy with an oncolytic virus of any type.
- Be receiving antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, ST-246).
- Have known allergy to ovalbumin or other egg products.
- Have clinically significant dermatological disorders (e.g., eczema, psoriasis, or any unhealed skin wounds or ulcers) as assessed by the treating physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Hospital Cancer Institute
Orlando, Florida, 32804
About this study
Official title: Use of GL-ONC1 in Patients With Advanced Cancers With No Standard of Care
GL-ONC1 expanded access is for patients who are ineligible for an ongoing GL-ONC1 clinical trial. Expanded access is intended to treat individual patients with advanced stage cancers, including blood cancer, with no standard of care options for treatment. Potential patients will be evaluated individually depending on GL-ONC1 product supply.
- Conditions
- Advanced Stage Cancer (Solid Tumor Disease for 4 Patients), Acute Myeloid Leukemia (6 Patients)
- Being tested
- GL-ONC1
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GL-ONC1Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Stage Cancer (Solid Tumor Disease for 4 Patients)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Genelux Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420430
- Sponsor's protocol ID
- GL-ONC1-021
- Status last verified
- Sep 2024
- First submitted
- 29 Jan 2018
- Last updated
- 25 Sep 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of GL-ONC1 in Patients With Advanced Cancers With No Standard of Care
- ClinicalTrials.gov ID
- NCT03420430
- Acronym / sponsor ID
- GL-ONC1-021
- Conditions
- Advanced Stage Cancer (Solid Tumor Disease for 4 Patients), Acute Myeloid Leukemia (6 Patients)
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Genelux CorporationIndustry (pharma, biotech, devices)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GL-ONC1 expanded access is for patients who are ineligible for an ongoing GL-ONC1 clinical trial. Expanded access is intended to treat individual patients with advanced stage cancers, including blood cancer, with no standard of care options for treatment. Potential patients will be evaluated individually depending on GL-ONC1 product supply.
Study design
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of advanced cancers with no standard of care option for treatment.
- Willing and able to provide written, signed informed consent.
- Use of adequate contraception.
- Negative pregnancy test.
Key exclusion criteria (8 listed)
- Have not recovered from severe adverse events from prior therapy.
- Major surgery occurred within 28 days prior to treatment.
- Known immune system disorders such as HIV, or active hepatitis B or C infection.
- Clinically significant cardiac disease (New York Heart Association Class III or IV).
- Have received prior therapy with an oncolytic virus of any type.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GL-ONC1 | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Sponsor websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GL-ONC1 in people with Advanced Stage Cancer (Solid Tumor Disease for 4 Patients) and Acute Myeloid Leukemia (6 Patients), run by Genelux Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.