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Trial record 2 of 2 for:    vivolux

Study of Safety and Tolerability of VLX600, an Iron Chelator, in Patients With Refractory Advanced Solid Tumors

This study is currently recruiting participants.
Verified June 2017 by Vivolux AB
Sponsor:
ClinicalTrials.gov Identifier:
NCT02222363
First Posted: August 21, 2014
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Theradex
Information provided by (Responsible Party):
Vivolux AB
  Purpose
The purpose of this study is to evaluate the safety and tolerability of the investigational drug VLX600 in patients with refractory advanced solid tumors.

Condition Intervention Phase
Refractory Cancer Drug: VLX600 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of the Safety and Tolerability of VLX600, an Iron Chelator, in Patients With Refractory Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Vivolux AB:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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). ]
    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.

  • 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 ]
    Blood samples will be collected for PK analysis at the specified time points in Cycle 1 only.

  • 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). ]

Estimated Enrollment: 48
Study Start Date: August 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VLX600
Dose of VLX600 in patients with refractory advanced solid tumors
Drug: VLX600
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women greater than or equal to 18 years of age.
  2. 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.
  3. 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.
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  5. 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
    • 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
  6. Women of childbearing potential must have a negative serum pregnancy test less than or equal to 7 days prior to registration.
  7. Life expectancy greater than 12 weeks.
  8. Must provide written informed consent.
  9. Must be willing to return to Mayo Clinic enrolling institution for follow-up.

Exclusion Criteria:

  1. 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.
  2. 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
    • 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
  3. Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment.
  4. Major surgery less than 28 days prior to study entry.
  5. 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.
  6. CNS metastases if not previously treated and stable for at least 2 months per imaging and clinical assessment.
  7. 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
  8. 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.
  9. 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).
  10. Corrected QT interval (QTc) interval greater than 450 msec (males) or greater than 470 msec (females).
  11. 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).
  12. Clinically relevant retinal abnormalities as per the medical history or ophthalmologic findings in the pretreatment evaluation (e.g., retinitis pigmentosa or macular degeneration).
  13. History of thromboembolism within the past 5 years, history of catheter-related thrombophlebitis or other clinically significant thrombophlebitis are excluded.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222363


Contacts
Contact: Clinical Trials Office - All Mayo Clinic Locations 855-776-0015 (toll free)

Locations
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Principal Investigator: Mitesh J Borad, MD         
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Principal Investigator: Elizabeth Johnson, MD         
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Aaron Mansfield, MD         
Sponsors and Collaborators
Vivolux AB
Theradex
Investigators
Study Chair: Elizabeth Johnson, MD Mayo Clinic
Principal Investigator: Aaron Mansfield, MD Mayo Clinic Rochester, MN
Principal Investigator: Mitesh J Borad, MD Mayo Clinic
  More Information

Responsible Party: Vivolux AB
ClinicalTrials.gov Identifier: NCT02222363     History of Changes
Other Study ID Numbers: V13-11045
IND 118039 ( Other Identifier: CDER/DOP2/OHOP )
First Submitted: August 15, 2014
First Posted: August 21, 2014
Last Update Posted: June 2, 2017
Last Verified: June 2017

Keywords provided by Vivolux AB:
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

Additional relevant MeSH terms:
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action