Status:
TERMINATED
Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in Adjuvant Colorectal Cancer
Lead Sponsor:
Egetis Therapeutics
Collaborating Sponsors:
Solasia Pharma K.K.
Conditions:
Colorectal Cancer
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is to evaluate PledOx for prevention of chronic chemotherapy induced peripheral neuropathy induced by oxaliplatin in patients with Stage III or high-risk Stage II colorectal cancer (CRC).
Detailed Description
This is a Phase 3, multicenter, double-blind, placebo-controlled study with PledOx for prevention of chronic CIPN induced by oxaliplatin in patients with Stage III or high-risk Stage II colorectal can...
Eligibility Criteria
Inclusion
- Signed informed consent form before any study related assessments and willing to follow all study procedures.
- Male or female aged ≥18 years.
- Pathologically confirmed adenocarcinoma of the colon or rectum including: Stage III carcinoma (any T N1,2 M0) or Stage II carcinoma (T3,4 N0 M0).
- The patient has undergone curative (R0) surgical resection performed within 12 weeks prior to randomization
- The patient has a postsurgical carcinoembryonic antigen (CEA) level ≤1.5 x upper limit of normal (ULN, in current smokers, CEA level ≤2.0 x ULN is allowed).
- No prior anti-cancer therapy for CRC except radiotherapy or concomitant chemo-radiotherapy using a fluoropyrimidine alone for locoregional rectal cancer.
- Patient indicated for up to 6 months of oxaliplatin-based chemotherapy and without pathological findings of a neurologic exam performed prior to oxaliplatin treatment according to local practice.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematological parameters: hemoglobin ≥100 g/L, absolute neutrophil count ≥1.5 x 109 /L, platelets ≥100 x 109 /L.
- Adequate renal function: creatinine clearance \>50 cc/min using the Cockcroft and Gault formula or measured.
- Adequate hepatic function: total bilirubin ≤1.5 x ULN (except in the case of known Gilbert's syndrome); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x ULN.
- Baseline blood manganese (Mn) level \<2.0 x ULN.
- For patients with a history of diabetes mellitus, HbA1c ≤7%.
- Negative pregnancy test for women of child-bearing potential (WOCBP).
- For men and WOCBP, use of adequate contraception (oral contraceptives, intrauterine device or surgically sterile) while on study drug and for at least 6 months after completion of study therapy.
Exclusion
- Any evidence of metastatic disease.
- Any unresolved toxicity by National Cancer Institute-Common Terminology Criteria for Adverse Events Version (NCI-CTCAE) v.4.03 \>Grade 1 from previous anti-cancer therapy (including radiotherapy), except alopecia.
- Any grade of neuropathy from any cause.
- Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, unresolved bowel obstruction, hepatic or renal disease).
- Chronic infection or uncontrolled serious illness causing immunodeficiency. Patients with known history of chronic hepatitis B can be enrolled if they are asymptomatic and an acute and active HBV infection can be excluded.
- Any history of seizures.
- A surgical incision that is not healed.
- Known hypersensitivity to any of the components of mFOLFOX6 and, if applicable, therapies to be used in conjunction with the chemotherapy regimen or any of the excipients of these products.
- History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for that other malignancy for at least 2 years.
- Known dihydropyrimidine dehydrogenase deficiency.
- Pre-existing neurodegenerative disease (e.g., Parkinson's, Alzheimer's, Huntington's) or neuromuscular disorder (e.g., multiple sclerosis, amyotrophic lateral sclerosis, polio, hereditary neuromuscular disease).
- Major psychiatric disorder (major depression, psychosis), alcohol and/or drug abuse.
- Patients with a history of second or third degree atrioventricular block or a family heredity.
- A history of a genetic or familial neuropathy.
- Treatment with any investigational drug within 30 days prior to randomization.
- Pregnancy, lactation or reluctance to using contraception.
- Any other condition that, in the opinion of the Investigator, places the patient at undue risk.
- Previous exposure to mangafodipir or calmangafodipir.
- Welders, mine workers or other workers in occupations (current or past) where high Mn exposure is likely.
Key Trial Info
Start Date :
January 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT04034355
Start Date
January 7 2019
End Date
August 31 2020
Last Update
January 26 2022
Active Locations (65)
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1
Onze-Lieve-Vrouwziekenuis Aalst
Aalst, Belgium
2
Imelda GI Clinical Research Center
Bonheiden, Belgium
3
Cliniques Universitaires St-Luc
Brussels, Belgium
4
UZ Gent
Ghent, Belgium