A Safety Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 62
Summary
- Conditions
- Colorectal Cancer
- Colorectal Carcinoma
- Colorectal Neoplasms
- Colorectal Tumors
- Neoplasms, Colorectal
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: This is a three-part study of NUC-3373 administered by intravenous infusion across two administration schedules, in separate combinations with LV, oxaliplatin, oxaliplatin+VEGF pathway inhibitors, oxaliplatin+EGFR inhibitors, irinotecan, irinotecan+VEGF pathway inhibitors and irinotecan+EGFR inhibitors. A minimum of 38 patients will be enrolled in Part 1 (LV cohorts only), up to 20 patients per cohort will be enrolled in Part 2 and 6 patients per cohort will be enrolled in Part 3. Additional patients may be enrolled in Parts 1, 2, or 3 to replace patients who withdraw prior to completing the 28-day safety evaluation period in Cycle 1 in order to complete the minimum number patients per cohort in all three parts. If the DSMC determines that an increased number of patients are required to evaluate alternate doses within a cohort, enrolment may be expanded.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT03428958
- Collaborators
- Not Provided
- Investigators
- Study Director: Elisabeth Oelmann, MD PhD NuCana plc
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