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

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multi-national, Multi-center, Parallel-group, Phase 2b Assessing ART-123's Effect on Preventing Sensory Symptoms of OIPN in Unresectable mCRC Subjects Receiving Oxaliplatin-containing Chemo

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04492436
• Other study ID #: 3-2001B
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 2021
• Est. completion date: July 2024

Study information

• Verified date: August 2021
• Source: Veloxis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2024
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• thrombomodulin alfa
Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle
• Placebo
Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Veloxis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	FACT/GOG-NTX-12 (4 items) Total Score at 9 Months	Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at 9 months	9 months
Secondary	FACT/GOG-NTX-12 (4 items) Proportional Score at Cycle 9 (each cycle is 2 weeks)	Proportion of subjects scoring 3 or 4 in at least 1 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	FACT/GOG-NTX-12 (4 items) Cumulative Score at Cycle 9	Cumulative incidence of scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOG-NTX-12 through Cycle 9	Cycle 9 (each cycle is 2 weeks)
Secondary	FACT/GOG-NTX-12 (12 items) Total Score at Cycle 9	Change from baseline in total score of FACT/GOG-NTX-12 at the end of Cycle 9	Cycle 9 (each cycle is 2 weeks)
Secondary	NRS (Pain) Scores (feet) at Cycle 9	Change from baseline score of NRS (Pain) in feet at the end of Cycle 9	Cycle 9 (each cycle is 2 weeks)
Secondary	NRS (Pain) Scores (hands) at Cycle 9	Change from baseline score of NRS (Pain) in hands at the end of Cycle 9	Cycle 9 (each cycle is 2 weeks)
Secondary	Side Effect Questionnaire Score	Change from baseline score of Side effect questionnaire at the end of Cycle 9	Cycle 9 (each cycle is 2 weeks)
Secondary	CTCAE: Peripheral Sensory Neuropathy	Proportion of subjects with each Grade of CTCAE peripheral sensory neuropathy at the end of Cycle 9	Cycle 9 (each cycle is 2 weeks)
Secondary	CTCAE: Peripheral Motor Neuropathy	Proportion of subjects with each Grade of CTCAE peripheral motor neuropathy at the end of Cycle 9	Cycle 9 (each cycle is 2 weeks)
Secondary	mTCNS Score	Change from baseline in total score of mTCNS at the end of Cycle 9	Cycle 9 (each cycle is 2 weeks)
Secondary	Grooved Pegboard Change	Change from baseline score in the time to complete the Grooved Pegboard test with the non-dominant hand at the end of Cycle 9	Cycle 9 (each cycle is 2 weeks)
Secondary	EQ-5D-5L Change	Change from baseline in EQ-5D-5L index value at the end of Cycle 9	Cycle 9 (each cycle is 2 weeks)