A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo
- Conditions
- Chemotherapy-induced Peripheral Neuropathy
- Interventions
- Drug: Placebo
- Registration Number
- NCT04492436
- Lead Sponsor
- Veloxis Pharmaceuticals
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. Low Dose thrombomodulin alfa 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. High Dose thrombomodulin alfa 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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) 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
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
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
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