Refractory CancerPhase 1NCT02222363
Study of Safety and Tolerability of VLX600, an Iron Chelator, in Patients With Refractory Advanced Solid Tumors
A Phase 1 study testing VLX600 in people with Refractory Cancer, run by Vivolux AB at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of the investigational drug VLX600 in patients with refractory advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Cancer
- What is being tested?
- VLX600
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Feb 2015to 28 Dec 2016
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women greater than or equal to 18 years of age.
- Histologic evidence of advanced solid tumors (excluding central nervous system (CNS) primary tumors) non-resectable, refractory to standard therapies, or patient cannot receive or refuses standard therapy.
- Solid tumors measurable according to RECIST 1.1 or solid tumors not measurable according to RECIST 1.1, but which express tumor markers (e.g., prostate cancer with prostate specific antigen (PSA) expression or ovarian cancer with cancer antigen-125 (CA-125) expression) are eligible.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Must have the following laboratory values, obtained less than or equal to 7 days prior to registration:
- Absolute neutrophil count (ANC) greater than or equal to 1500/µL
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- Platelet (PLT) count greater than or equal to 100,000/µL
- Total bilirubin less than 1.5 x upper normal limit (UNL)
- Aspartate aminotransferase (AST) (SGOT) less than or equal to 3 x UNL
- Creatinine less than 1.5 x UNL
- Women of childbearing potential must have a negative serum pregnancy test less than or equal to 7 days prior to registration.
- Life expectancy greater than 12 weeks.
- Must provide written informed consent.
- Must be willing to return to Mayo Clinic enrolling institution for follow-up.
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes mellitus, seizure disorder or psychiatric illness/social situations that would limit compliance with study requirements.
- Treatment with any of the following prior therapies:
- Chemotherapy less than or equal to 4 weeks prior to registration
- Mitomycin C/nitrosoureas less than or equal to 6 weeks prior to registration
- Immunotherapy less than or equal to 4 weeks prior to registration
- Biologic therapy less than or equal to 4 weeks prior to registration
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- Radiation therapy less than or equal to 4 weeks prior to registration
- Non-cytotoxic therapy less than or equal to 5 half-lives prior to registration
- Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment.
- Major surgery less than 28 days prior to study entry.
- Active other malignancy, except non-melanoma skin cancer or carcinoma-in-situ (e.g., of cervix, breast, prostate). If there is a history of prior malignancy, patient must not be receiving other specific treatment (other than hormonal therapy) for the cancer.
- CNS metastases if not previously treated and stable for at least 2 months per imaging and clinical assessment.
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant women
- Nursing women
- Men or women of childbearing potential unwilling to employ adequate contraception
- Other concurrent chemotherapy, immunotherapy, radiotherapy, any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation) or receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
- Cardiac issues consisting of either symptomatic congestive heart failure (NYHA Class II or higher), unstable angina pectoris, myocardial infarction within 6 months, and/or cardiac arrhythmia, including atrial fibrillation (which is symptomatic or requires treatment).
- Corrected QT interval (QTc) interval greater than 450 msec (males) or greater than 470 msec (females).
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients with a known history of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Clinically relevant retinal abnormalities as per the medical history or ophthalmologic findings in the pretreatment evaluation (e.g., retinitis pigmentosa or macular degeneration).
- History of thromboembolism within the past 5 years, history of catheter-related thrombophlebitis or other clinically significant thrombophlebitis are excluded.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499
About this study
Official title: A Phase I Study of the Safety and Tolerability of VLX600, an Iron Chelator, in Patients With Refractory Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of the investigational drug VLX600 in patients with refractory advanced solid tumors.
Read the detailed description
This Phase I, open label dose escalation study of VLX600 in patients with refractory advanced solid tumors will determine the safety profile and maximum tolerated dose (MTD) of VLX600 when administered by intravenous infusion on Days 1, 8, and 15 of each 28-day treatment cycle. Dose escalation will proceed according to the standard "3 + 3" design using doubling doses. The doses are: 10, 20, 40, 80, 160, and 210 mg VLX600.
- Conditions
- Refractory Cancer
- Being tested
- VLX600
- Keywords
- Phase I, Iron chelator, Refractory advanced solid tumors, Dose escalation study, Safety and tolerability, Tumor response by RECIST 1.1, Progression-free survival, Overall survival Pharmacokinetics
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLX600Drug
Patients will receive a dose of VLX600 by 4-hr intravenous infusion using a central venous catheter on Days 1, 8, and 15 of each 28-day treatment cycle. There are the following dose cohorts: 10, 20, 40, 80, 160, and 210 mg VLX600. It is anticipated that patients will receive 6 treatment cycles. In the absence of unacceptable toxicity and disease progression, patients have the option of continuing treatment beyond 6 cycles, if the investigator determines that the patient may benefit further from it.
| Study group | Role | What they receive |
|---|---|---|
| VLX600 | Experimental | Dose of VLX600 in patients with refractory advanced solid tumors Receives: Drug: VLX600 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adverse event (AE) profile
Measured: AEs are assessed from first treatment day through at least 30 days after last treatment.
Determination of the maximum tolerated dose (MTD) of VLX600
Measured: MTD will be determined during dose escalation phase of study, up to one year.
Determination of the recommended Phase II dose (RPTD) of VLX600
Measured: Determination of RPTD will be based on adverse event profile, up to one year.
Secondary outcomes (4)
Description of the tumor response to VLX600 treatment
Tumor response will be determined using CT scans or magnetic resonance imaging (MRI) at pre-treatment, Cycle 2 Day 28, at every 8 weeks thereafter, and at off-study (if a scan has not been performed within the last prior 4 weeks). Patients in the MTD confirmation cohort only will have a pre-treatment baseline positron emission tomography- computerized tomography (PET-CT) scan and then at Cycle 2 Day 28. Tumor response will be determined by Response Criteria in Solid Tumors (RECIST) version 1.1. In patients with disease not measurable by RECIST 1.1, blood samples for biomarkers of tumor response will be collected at pre-treatment baseline and then after every 8 weeks.
Measured: Tumor response will be evaluated by CT scans or MRI at pre-treatment baseline and on Cycle 2 Day 28, then after every 8 weeks, and then at off-study (if greater than 4 weeks since prior tumor assessment).
Description of progression-free survival
Measured: Progression-free survival is calculated from date of first treatment until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 200 days (through 6 treatment cycles).
Description of the pharmacokinetics (PK) of VLX600
Blood samples will be collected for PK analysis at the specified time points in Cycle 1 only.
Measured: PK assessed in Cycle 1 only. Day 1: pre-dose, 15, 30, 60 min, and 2, 4, 4.25, 4.5, 5, 8 hrs post start of infusion. Day 2: 24 hr post-start of infusion. Day 8: pre-dose, Day 15 (same as Day 1), Day 16: 24 hr post-start of infusion, and Day 22: pre-dose
Description of overall survival.
Measured: Overall survival will be determined from date of first study treatment until death due to any cause, up to 72 weeks (duration of study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study start18 Feb 2015
- Primary completion28 Dec 2016
- Study completion28 Dec 2016
Why it stopped: Slow recruitment and lack of efficacy despite the completion of several dose steps.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory CancerStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivolux AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theradex
- Responsible party
- Sponsor
- Investigators
- Elizabeth Johnson, MD, Study chair, Mayo ClinicAaron Mansfield, MD, Principal investigator, Mayo Clinic, Rochester, MNMitesh J Borad, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222363
- Sponsor's protocol ID
- V13-11045
- Other IDs
- IND 118039
- Status last verified
- May 2018
- First submitted
- 15 Aug 2014
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety and Tolerability of VLX600, an Iron Chelator, in Patients With Refractory Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02222363
- Acronym / sponsor ID
- V13-11045
- Conditions
- Refractory Cancer
- Keywords
- Phase I, Iron chelator, Refractory advanced solid tumors, Dose escalation study, Safety and tolerability, Tumor response by RECIST 1.1, Progression-free survival, Overall survival Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment and lack of efficacy despite the completion of several dose steps.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Vivolux ABIndustry (pharma, biotech, devices)
- Collaborators
- Theradex
- Study start
- 18 Feb 2015 (actual)
- Primary completion
- 28 Dec 2016 (actual)
- Study completion
- 28 Dec 2016 (actual)
- First posted
- 21 Aug 2014 (estimated)
- 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.
The purpose of this study is to evaluate the safety and tolerability of the investigational drug VLX600 in patients with refractory advanced solid tumors.
Detailed description
This Phase I, open label dose escalation study of VLX600 in patients with refractory advanced solid tumors will determine the safety profile and maximum tolerated dose (MTD) of VLX600 when administered by intravenous infusion on Days 1, 8, and 15 of each 28-day treatment cycle. Dose escalation will proceed according to the standard "3 + 3" design using doubling doses. The doses are: 10, 20, 40, 80, 160, and 210 mg VLX600.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VLX600 | Experimental | Drug: VLX600Dose of VLX600 in patients with refractory advanced solid tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Men and women greater than or equal to 18 years of age.
- Histologic evidence of advanced solid tumors (excluding central nervous system (CNS) primary tumors) non-resectable, refractory to standard therapies, or patient cannot receive or refuses standard therapy.
- Solid tumors measurable according to RECIST 1.1 or solid tumors not measurable according to RECIST 1.1, but which express tumor markers (e.g., prostate cancer with prostate specific antigen (PSA) expression or ovarian cancer with cancer antigen-125 (CA-125) expression) are eligible.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Must have the following laboratory values, obtained less than or equal to 7 days prior to registration:
Key exclusion criteria (22 listed)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes mellitus, seizure disorder or psychiatric illness/social situations that would limit compliance with study requirements.
- Treatment with any of the following prior therapies:
- Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment.
- Major surgery less than 28 days prior to study entry.
- Active other malignancy, except non-melanoma skin cancer or carcinoma-in-situ (e.g., of cervix, breast, prostate). If there is a history of prior malignancy, patient must not be receiving other specific treatment (other than hormonal therapy) for the cancer.
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 |
|---|---|---|
| VLX600Patients will receive a dose of VLX600 by 4-hr intravenous infusion using a central venous catheter on Days 1, 8, and 15 of each 28-day treatment cycle. There are the following dose cohorts: 10, 20, 40, 80, 160, and 210 mg VLX600. It is anticipated that patients will receive 6 treatment cycles. In the absence of unacceptable toxicity and disease progression, patients have the option of continuing treatment beyond 6 cycles, if the investigator determines that the patient may benefit further from it. | Drug | VLX600 |
Primary outcome
Assessment of adverse event (AE) profile
Time frame: AEs are assessed from first treatment day through at least 30 days after last treatment.
Determination of the maximum tolerated dose (MTD) of VLX600
Time frame: MTD will be determined during dose escalation phase of study, up to one year.
Determination of the recommended Phase II dose (RPTD) of VLX600
Time frame: Determination of RPTD will be based on adverse event profile, up to one year.
4 secondary outcomes
Description of the tumor response to VLX600 treatment
Time frame: Tumor response will be evaluated by CT scans or MRI at pre-treatment baseline and on Cycle 2 Day 28, then after every 8 weeks, and then at off-study (if greater than 4 weeks since prior tumor assessment).
Description of progression-free survival
Time frame: Progression-free survival is calculated from date of first treatment until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 200 days (through 6 treatment cycles).
Description of the pharmacokinetics (PK) of VLX600
Time frame: PK assessed in Cycle 1 only. Day 1: pre-dose, 15, 30, 60 min, and 2, 4, 4.25, 4.5, 5, 8 hrs post start of infusion. Day 2: 24 hr post-start of infusion. Day 8: pre-dose, Day 15 (same as Day 1), Day 16: 24 hr post-start of infusion, and Day 22: pre-dose
Description of overall survival.
Time frame: Overall survival will be determined from date of first study treatment until death due to any cause, up to 72 weeks (duration of study).
Results and safety
The study was stopped early (reason given: Slow recruitment and lack of efficacy despite the completion of several dose steps.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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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.
Elizabeth Johnson, MD study chair
Mayo Clinic
Aaron Mansfield, MD principal investigator
Mayo Clinic, Rochester, MN
Mitesh J Borad, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VLX600 in people with Refractory Cancer, run by Vivolux AB at 3 sites 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 14 inclusion and 22 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: stopped early, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment and lack of efficacy despite the completion of several dose steps.). 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.
What does the primary outcome measure?
Assessment of adverse event (AE) profile (time frame: AEs are assessed from first treatment day through at least 30 days after last treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 11 May 2018.