Clinical trialNARecruiting
GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
- Outcome
- Ongoing
- Phase
- NA
- Status
- Recruiting
- Study type
- Interventional
- Start
- 28 September 2022
- Expected end
- May 2027
- Enrollment
- 178 participants
- Sites
- 1
- Primary outcomes
- Adverse Events Frequency
- Sponsor
- Other
- Results posted
- No
- Last update
- 16 December 2025
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Source text
Brief summary public domain (ClinicalTrials.gov)
This is a prospective, randomized study designed to compare genotype-guided dosing to usual care in patients with pancreas cancer and colorectal cancer who are UGT1A1 intermediate metabolizers (\*1/\*28) (heterozygotes) and usual UGT metabolizers (\*1/\*1). All patients will be assessed for UGT1A1 genotype at screening and those with intermediate or usual UGT1A1 genotypes (\*1/\*28, \*1/\*1) will be randomized to genotype-guided dosing versus usual care.
Intervention public domain (ClinicalTrials.gov)
Drug: Irinotecan. Usual dosing per package insert.
Arm public domain (ClinicalTrials.gov)
Genocare Guided (experimental):
Arm public domain (ClinicalTrials.gov)
Usual Care (no intervention):
Primary outcome public domain (ClinicalTrials.gov)
Adverse Events Frequency. To compare the frequency of cycle 1 grade 3-5 adverse effects in individuals with a \*1/\*28 or \*1/\*1 genotype who receive genotype-guided dosing and to those who are randomized to receive usual care. Time frame: 6 months.
Secondary outcome public domain (ClinicalTrials.gov)
Overall Survival. Time frame: 5 years.
Eligibility public domain (ClinicalTrials.gov)
Inclusion Criteria: * Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment. * Prior treatment is allowed, specifically surgery and/or radiation and non-irinotecan containing regimens are allowed. * Age ≥ 18 years. * ECOG performance status ≤ 1. * Patients must have adequate organ and marrow function as defined below: * Measurable or non-measurable disease. Exclusion Criteria: * Patients who received prior treatment with irinotecan are excluded. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician. * Pregnant women are excluded from this study. * Patients who are not planned for treatment of their cancer.
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 178 participants (estimated).