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.
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.
Brief Title
The Purpose of This Study is to Determine if Tetrodotoxin (TTX) is Effective in the Treatment of Pain Resulting From Chemotherapy Treatment
Categories
Completion Date
Completion Date Type
Actual
Conditions
Pain
Peripheral Neuropathy
Neuropathic Pain
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
* 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
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Pain
Puffer fish
Tetrodotoxin
TTX
Neuropathy
Chemotherapy
WEX Pharmaceuticals
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01655823
Org Class
Industry
Org Full Name
Wex Pharmaceuticals Inc.
Org Study Id
TTX-CINP-201
Overall Status
Terminated
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized, Double-Blind, Dose-Finding, Placebo Controlled, Phase II Multicenter Study of Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain
Primary Outcomes
Outcome Description
The primary efficacy endpoint for Part I was the change from baseline in weekly average NPRS scores at 22 to 28 days after treatment. Baseline was defined as the average of NPRS scores for the last 7 days prior to dosing. Pain was assessed using a Numerical Pain Rating Scale (NPRS) with a range of 0 (no pain) to 10 (extreme pain).
Outcome Measure
Change From Baseline in Patient Reported Outcome for Pain at Day 22 to Day 28.
Outcome Time Frame
Day 22 to Day 28
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jerome Graber
Investigator Email
jgraber@montefiore.org
Investigator Phone
718-920-5505