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

NCT04492436 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 3-2001B
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• FACT/GOG-NTX-12 (4 items) Total Score at Cycle 9

  Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at the end of Cycle 9

  Cycle 9 (each cycle is 2 weeks)

Secondary Outcomes (12)

• FACT/GOG-NTX-12 (4 items) Total Score at 9 Months

  9 months

• FACT/GOG-NTX-12 (4 items) Proportional Score at Cycle 9 (each cycle is 2 weeks)

  Cycle 9 (each cycle is 2 weeks)

• FACT/GOG-NTX-12 (4 items) Cumulative Score at Cycle 9

  Cycle 9 (each cycle is 2 weeks)

• FACT/GOG-NTX-12 (12 items) Total Score at Cycle 9

  Cycle 9 (each cycle is 2 weeks)

• NRS (Pain) Scores (feet) at Cycle 9

  Cycle 9 (each cycle is 2 weeks)

Study Arms (3)

Low Dose

EXPERIMENTAL

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.

Drug: thrombomodulin alfa

High Dose

EXPERIMENTAL

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.

Drug: thrombomodulin alfa

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

thrombomodulin alfa DRUG

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

Also known as: ART-123

High Dose; Low Dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Veloxis Pharmaceuticals: lead

MeSH Terms

Interventions

ART123

Study Officials

• David Fineberg, MD

  Veloxis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 30, 2020
• Study Start: October 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: July 1, 2024
• Last Updated: February 18, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share