Chemotherapy-induced Peripheral Neuropathy
Conditions
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
Interventions
Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle
DRUGPlacebo
Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle
Sponsors
Veloxis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FACT/GOG-NTX-12 (4 items) Total Score at Cycle 9 | Cycle 9 (each cycle is 2 weeks) | Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at the end of Cycle 9 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FACT/GOG-NTX-12 (4 items) Proportional Score at Cycle 9 (each cycle is 2 weeks) | 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 |
| FACT/GOG-NTX-12 (4 items) Cumulative Score at Cycle 9 | Cycle 9 (each cycle is 2 weeks) | 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 |
| FACT/GOG-NTX-12 (12 items) Total Score at Cycle 9 | Cycle 9 (each cycle is 2 weeks) | Change from baseline in total score of FACT/GOG-NTX-12 at the end of Cycle 9 |
| NRS (Pain) Scores (feet) at Cycle 9 | Cycle 9 (each cycle is 2 weeks) | Change from baseline score of NRS (Pain) in feet at the end of Cycle 9 |
| NRS (Pain) Scores (hands) at Cycle 9 | Cycle 9 (each cycle is 2 weeks) | Change from baseline score of NRS (Pain) in hands at the end of Cycle 9 |
| FACT/GOG-NTX-12 (4 items) Total Score at 9 Months | 9 months | Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at 9 months |
| CTCAE: Peripheral Sensory Neuropathy | Cycle 9 (each cycle is 2 weeks) | Proportion of subjects with each Grade of CTCAE peripheral sensory neuropathy at the end of Cycle 9 |
| CTCAE: Peripheral Motor Neuropathy | Cycle 9 (each cycle is 2 weeks) | Proportion of subjects with each Grade of CTCAE peripheral motor neuropathy at the end of Cycle 9 |
| mTCNS Score | Cycle 9 (each cycle is 2 weeks) | Change from baseline in total score of mTCNS at the end of Cycle 9 |
| Grooved Pegboard Change | Cycle 9 (each cycle is 2 weeks) | Change from baseline score in the time to complete the Grooved Pegboard test with the non-dominant hand at the end of Cycle 9 |
| EQ-5D-5L Change | Cycle 9 (each cycle is 2 weeks) | Change from baseline in EQ-5D-5L index value at the end of Cycle 9 |
| Side Effect Questionnaire Score | Cycle 9 (each cycle is 2 weeks) | Change from baseline score of Side effect questionnaire at the end of Cycle 9 |
Outcome results
None listed