A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo

NCT ID: NCT04492436

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2024-07-31

Brief Summary

To evaluate the efficacy and safety of ART-123 on sensory symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy

Detailed Description

To compare the efficacy and safety of ART-123 (low and high dose) to placebo on sensory symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Low Dose

Reconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.

Group Type: EXPERIMENTAL

thrombomodulin alfa

Intervention Type: DRUG

Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle

High Dose

Reconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.

Group Type: EXPERIMENTAL

thrombomodulin alfa

Intervention Type: DRUG

Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle

Placebo

Reconstituted lyophilized placebo with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle

Interventions

thrombomodulin alfa

Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle

Intervention Type: DRUG

Placebo

Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle

Intervention Type: DRUG

Other Intervention Names

ART-123

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• Unresectable metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
• ECOG performance status of 0 or 1
• The most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges
• Willingness of the patient and the sexual partner to use a highly effective contraceptive method during the course of the study
• Able to sufficiently understand the clinical study and give written informed consent

Exclusion Criteria

• Prior treatment history with nerve toxic chemotherapeutic agent
• Peripheral neuropathy or central nervous system damage
• Psychiatric disorder
• History of major hemorrhage
• High risk of hemorrhage
• History of other malignancies
• Active ulcer
• Patients using anti-coagulants and fibrinolytic drugs
• Active Hepatitis B, or known HBs antigen positive
• Prior treatment history with thrombomodulin alfa
• Administration of another investigational medicinal product within 30 days prior to randomization
• Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period
• Patients otherwise deemed as inappropriate to participate in the study by the Investigator

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Veloxis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Fineberg, MD

Role: STUDY_DIRECTOR

Veloxis Pharmaceuticals

Other Identifiers

3-2001B

Identifier Type: -

Identifier Source: org_study_id