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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle
Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle
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
Time frame: Cycle 9 (each cycle is 2 weeks)
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
Time frame: 9 months
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
Time frame: Cycle 9 (each cycle is 2 weeks)
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
Time frame: Cycle 9 (each cycle is 2 weeks)
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
Time frame: Cycle 9 (each cycle is 2 weeks)
NRS (Pain) Scores (feet) at Cycle 9
Change from baseline score of NRS (Pain) in feet at the end of Cycle 9
Time frame: Cycle 9 (each cycle is 2 weeks)
NRS (Pain) Scores (hands) at Cycle 9
Change from baseline score of NRS (Pain) in hands at the end of Cycle 9
Time frame: Cycle 9 (each cycle is 2 weeks)
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Side Effect Questionnaire Score
Change from baseline score of Side effect questionnaire at the end of Cycle 9
Time frame: Cycle 9 (each cycle is 2 weeks)
CTCAE: Peripheral Sensory Neuropathy
Proportion of subjects with each Grade of CTCAE peripheral sensory neuropathy at the end of Cycle 9
Time frame: Cycle 9 (each cycle is 2 weeks)
CTCAE: Peripheral Motor Neuropathy
Proportion of subjects with each Grade of CTCAE peripheral motor neuropathy at the end of Cycle 9
Time frame: Cycle 9 (each cycle is 2 weeks)
mTCNS Score
Change from baseline in total score of mTCNS at the end of Cycle 9
Time frame: Cycle 9 (each cycle is 2 weeks)
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
Time frame: Cycle 9 (each cycle is 2 weeks)
EQ-5D-5L Change
Change from baseline in EQ-5D-5L index value at the end of Cycle 9
Time frame: Cycle 9 (each cycle is 2 weeks)