Metastatic colorectal cancer that is resistant to the currently approved methods of treatment is recognized as a serious threat to public health worldwide. Research efforts in recent years have become increasingly geared towards discovering and developing new treatment regimens with modes of action distinct from those of established agents and with the ability to target subclasses of colorectal cancer, such as those associated with RAS mutations.
Conditions
Brief summary
Overall response rate (ORR)
Detailed description
Progression-free survival (PFS) (key secondary objective): Overall survival (OS); Duration of response (DoR); Disease control rate (DCR), Adverse events, performance status (Eastern Cooperative Oncology Group [ECOG]), physical examinations, clinical laboratory values, vital signs, electrocardiogram, Steady state concentration, CKB levels identified in baseline tumor samples
Interventions
DRUGFOLINIC ACID
DRUGFLUOROURACIL
DRUGBEVACIZUMAB
DRUGIRINOTECAN
DRUGPlacebo to Match Ompenaclid 600 mg Tablets are intended for oral administration. The placebo tablets are yellow
DRUGmodified oval and biconvex film-coated tablets that are approximately 9 mm in width and 18.8 mm in length. Composition of placebo tablets: Lactose Monohydrate (708mg)
DRUGMicrocrystalline Cellulose (263 mg)
DRUGCroscarmellose Sodium (30 mg)
DRUGMagnesium Stearate (vegetable grade) (10 mg)
DRUGOpadry®03K12480 Yellow (30mg)
DRUGpurified water (q.c.). total weight: 1042 mg.
DRUGompenaclid
Sponsors
Inspirna Inc., Inspirna Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) (key secondary objective): Overall survival (OS); Duration of response (DoR); Disease control rate (DCR), Adverse events, performance status (Eastern Cooperative Oncology Group [ECOG]), physical examinations, clinical laboratory values, vital signs, electrocardiogram, Steady state concentration, CKB levels identified in baseline tumor samples | — |
Countries
Belgium, France, Spain
Outcome results
None listed