Clinical trial NCT01655823: The Purpose of This Study is to Determine if Tetrodotoxin (TTX) is Effective in the Treatment of Pain Resulting From Chemotherapy Treatment
Official title: A Randomized, Double-Blind, Dose-Finding, Placebo Controlled, Phase II Multicenter Study of Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Peripheral Neuropathy
Neuropathic Pain
Keywords: Pain
Puffer fish
Tetrodotoxin
TTX
Neuropathy
Chemotherapy
WEX Pharmaceuticals
Lead sponsor: Wex Pharmaceuticals Inc.
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
First posted: 2012-08-02
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting side effect of many chemotherapeutic agents including vincristine, paclitaxel, cisplatin, oxaliplatin, bortezomib and ixabepilone. Chemotherapy-induced peripheral neuropathy commonly occurs in greater than 40% of patients. To improve the peripheral neuropathy, the chemotherapy dosing is often either decreased or discontinued potentially affecting tumor responsiveness, prognosis, and survival.

There is an unmet medical need for treatment of cancer patients with chemotherapy induced neuropathic pain (CINP) and the proposed study will investigate the efficacy and safety of multiple dose levels of tetrodotoxin (TTX) versus placebo in moderate to severe neuropathic pain caused by chemotherapy.


Eligibility criteria: Inclusion Criteria:

* If female, not of childbearing potential.
* Patients with documented neuropathic pain
* Cancer Patients who have completed a chemotherapy regimen which included taxanes or platinums (or both) and have no evidence actively progressive disease. Concurrent hormonal therapies are allowed
* Patients with stable moderate to severe neuropathic pain
* Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
* Patients who are able to complete the study-related questionnaires independently in either English or Spanish.

Exclusion Criteria:

* History of peripheral neuropathy attributed to any cause other than chemotherapy.
* Patients receiving any concurrent agents known to cause peripheral neuropathy within 30 days of Randomization.
* Current use of other therapy (ies), including "alternative" therapies, for treatment of peripheral neuropathy within 30 days of Randomization (with the exception of protocol allowed concurrent medications).
* Patients who used controlled release opioids within seven days of baseline period or who expect to use controlled release opioids at any time from baseline to end of study.
* Patients with abnormal kidney function.
* Patients with bone metastases.
* Patients scheduled for treatment for their cancer with chemotherapy or radiotherapy between screening and the end of study visit.
* Current use of lidocaine and other types of antiarrhythmic drugs within 30 days of Randomization.
* Current use of scopolamine and acetylcholinesterase-inhibiting drugs such as physostigmine within 30 days of Randomization.
* Current cause of Chemotherapy Induced Neuropathic Pain attributed to Velcade (Bortezomib) or vinca alkaloids or analogues such as vincristine, vinblasine, vinorelbine and vindesine.
* Current use of tricyclic antidepressant medication, anticonvulsants and monoamine oxidase inhibitors.
* Patients with current uncontrolled asthma or lung disease.
* Patients with significant heart disease.
* Use of an investigational agent within 30 days prior to screening or is scheduled to receive an investigational drug other than TTX during the course of the study.
* Females who are pregnant or nursing

Primary outcomes:
measure: Change From Baseline in Patient Reported Outcome for Pain at Day 22 to Day 28.
timeFrame: Day 22 to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Lalita Pandit
state: California
city: Fountain Valley
country: United States
facility: Robert Moss
state: California
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: Los Angeles
country: United States
facility: Global Research Management
state: California
city: Los Angeles
country: United States
facility: Innovative Clinical Research
state: California
city: Mountain View
country: United States
facility: El Camino Cancer Center
state: California
city: Salinas
country: United States
facility: Pacific Cancer Care
state: California
city: Santa Rosa
country: United States
facility: Redwood Regional Medical Group
state: California
city: Bridgeport
country: United States
facility: St. Vincent's Medical Center
state: Connecticut
city: Port Charlotte
country: United States
facility: Medsol Clinical Research Center
state: Florida
city: Wellington
country: United States
facility: Axcess Medical Research
state: Florida
city: Dublin
country: United States
facility: Cancer Center of Middle Georgia
state: Georgia
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Bridgeton
country: United States
facility: St. Louis Cancer Care
state: Missouri
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology Consultants
state: New Mexico
city: Middletown
country: United States
facility: Signal Point Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Institute of Pain Research
state: Oklahoma
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Hackensack University
name: Samuel Goldlust, MD
role: PRINCIPAL_INVESTIGATOR
References: