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

Vivolux AB3 sites in 1 country19 target enrollmentFebruary 18, 2015

ConditionsRefractory Cancer

InterventionsVLX600

DrugsVLX600

Overview

Phase: Phase 1
Intervention: VLX600
Conditions: Refractory Cancer
Sponsor: Vivolux AB
Enrollment: 19
Locations: 3
Primary Endpoint: Assessment of adverse event (AE) profile
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

February 18, 2015

End Date

December 28, 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Vivolux AB

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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

Exclusion Criteria

•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.

Arms & Interventions

VLX600

Dose of VLX600 in patients with refractory advanced solid tumors

Intervention: VLX600

Outcomes

Primary Outcomes

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 Outcomes

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).)