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

NCT02222363 | Terminated Phase 1

• 2 other identifiers: V13-11045IND 118039
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• Assessment of adverse event (AE) profile

  AEs are assessed from first treatment day through at least 30 days after last treatment.

• Determination of the maximum tolerated dose (MTD) of VLX600

  MTD will be determined during dose escalation phase of study, up to one year.

• Determination of the recommended Phase II dose (RPTD) of VLX600

  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 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

  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

  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.

  Overall survival will be determined from date of first study treatment until death due to any cause, up to 72 weeks (duration of study).

Study Arms (1)

VLX600

EXPERIMENTAL

Dose of VLX600 in patients with refractory advanced solid tumors

Drug: VLX600

Interventions

VLX600 DRUG

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.

VLX600

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vivolux AB: lead
• Theradex: collaborator

Study Sites (3)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

VLX600

Study Officials

• Elizabeth Johnson, MD

  Mayo Clinic

  STUDY CHAIR

• Aaron Mansfield, MD

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

• Mitesh J Borad, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 21, 2014
• Study Start: February 18, 2015
• Primary Completion: December 28, 2016
• Study Completion: December 28, 2016
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (3)