This study will assess pharmacokinetic (PK)/pharmacodynamic (PD) relationships and whether BXQ-350 may decrease the intensity and/or duration of chemotherapy induced peripheral neuropathy (CIPN) thereby improving quality of life (QoL) in cancer patients who have been exposed to oxaliplatin and/or taxane-based chemotherapy. This study includes two randomized, placebo controlled, blinded treatment cycles of BXQ-350/placebo, an optional open-label BXQ-350 treatment period, and an unblinded Post-Treatment Follow-up period.
BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a cell membrane phospholipid (clinical formulation BXQ-350).Due to the presumed mechanism of action of BXQ-350, Bexion anticipates that it may have an impact on ceramides, sphingosine-1-phosphate (S1P), and inflammatory cytokine levels. In addition, pre-clinical results demonstrated that BXQ-350 induced neurite generation and protection in vitro in the PC-12 and NS20Y cell lines and significantly decreased oxaliplatin-induced cold allodynia in a model of CIPN. Thus BXQ-350 may represent a new approach to deliver a neuropathy benefit. The unique combination of SapC-DOPS along with its proven safety profile and possible neuropathy benefit makes BXQ-350 a worthwhile candidate to test on cancer patients affected by CIPN. The aim of this pilot proof-of-concept study is to assess PK/PD relationships in cancer patients with CIPN symptoms in order to determine the impact BXQ-350 has on ceramide, S1P, and inflammatory cytokine levels; thereby potentially reducing the intensity and/or duration of CIPN, improving QoL, and establishing these signaling molecules as biomarkers in future studies. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). BXQ-350 will be administered by intravenous (IV) infusion
Placebo will be 0.9% normal saline of matching volume to BXQ-350 administered by intravenous (IV) infusion
CTI Clinical Research Center
Cincinnati, Ohio, United States
The Ohio State Unviersity
Columbus, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Peak Plasma Concentration (Cmax)
To evaluate the Cmax of BXQ-350.
Time frame: 6 months
Ceramide
To evaluate ceramide levels following administration of BXQ-350.
Time frame: 6 months
S1P levels
To evaluate S1P levels following administration of BXQ-350.
Time frame: 6 months
Cytokine levels
To evaluate cytokine levels following administration of BXQ-350.
Time frame: 6 months
Quality of Life (QoL)
To evaluate QoL in patients with neuropathy receiving BXQ-350. QoL will be measured utilizing the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: 6 months
Total Sensory Neuropathy
To evaluate neuropathy symptoms in patients with neuropathy receiving BXQ-350. Total sensory neuropathy scores will be obtained from the EORTC QLQ-CIPN20 questionnaire.
Time frame: 6 months
CIPN Assessment
To evaluate CIPN symptoms in patients with neuropathy receiving BXQ-350 utilizing the CIPN Assessment Tool questionnaire.
Time frame: 6 months
Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0
To further assess the overall safety and tolerability of BXQ-350as evidenced by the incidence of treatment emergent adverse events assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
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Masking
QUADRUPLE
Enrollment
21
Time frame: 6 months