Clinical trial NCT04492436: A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Veloxis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-07-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: FACT/GOG-NTX-12 (4 items) Total Score at Cycle 9
timeFrame: Cycle 9 (each cycle is 2 weeks)
Secondary outcomes:
measure: FACT/GOG-NTX-12 (4 items) Total Score at 9 Months
timeFrame: 9 months
measure: FACT/GOG-NTX-12 (4 items) Proportional Score at Cycle 9 (each cycle is 2 weeks)
timeFrame: Cycle 9 (each cycle is 2 weeks)
measure: FACT/GOG-NTX-12 (4 items) Cumulative Score at Cycle 9
timeFrame: Cycle 9 (each cycle is 2 weeks)
measure: FACT/GOG-NTX-12 (12 items) Total Score at Cycle 9
timeFrame: Cycle 9 (each cycle is 2 weeks)
measure: NRS (Pain) Scores (feet) at Cycle 9
timeFrame: Cycle 9 (each cycle is 2 weeks)
measure: NRS (Pain) Scores (hands) at Cycle 9
timeFrame: Cycle 9 (each cycle is 2 weeks)
measure: Side Effect Questionnaire Score
timeFrame: Cycle 9 (each cycle is 2 weeks)
measure: CTCAE: Peripheral Sensory Neuropathy
timeFrame: Cycle 9 (each cycle is 2 weeks)
measure: CTCAE: Peripheral Motor Neuropathy
timeFrame: Cycle 9 (each cycle is 2 weeks)
measure: mTCNS Score
timeFrame: Cycle 9 (each cycle is 2 weeks)
measure: Grooved Pegboard Change
timeFrame: Cycle 9 (each cycle is 2 weeks)
measure: EQ-5D-5L Change
timeFrame: Cycle 9 (each cycle is 2 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Veloxis Pharmaceuticals
name: David Fineberg, MD
role: STUDY_DIRECTOR
References: