NCT01040312CompletedNot Applicable
A Prospective Observational Study of the Efficacy and Safety of CPT-11 Plus Platinum Analogues Regimens for UGT1A1 Genotype Guided Patients With Several Solid Tumors
Daiichi Sankyo Co., Ltd.1 site in 1 country321 target enrollmentStarted: October 15, 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Enrollment
- 321
- Locations
- 1
- Primary Endpoint
- Number of Participants with UGT1A1 Genotype with Severe Toxicities Induced by CPT-11 with Platinum Analogues
Study Overview
Brief Summary
The purpose of this study is to examine the correlation between UGT1A1 genotypes and the safety of CPT-11 plus platinum analogues (cisplatin, carboplatin and nedaplatin) regimens for patients with lung cancer, cervical cancer, ovarian cancer and gastric cancer.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Has small cell lung cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and/or gastric cancer
- •Has UGT1A1 genotype *1/*6, *1/*28, *6/*6, *28/*28 and *6/*28
- •Is receiving CPT-11 plus platinum analogue (cisplatin, carboplatin and nedaplatin) regimens (with or without molecular targeted agents)
Exclusion Criteria
- •Has contraindication for CPT-11
- •Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 3-4
Arms & Interventions
UGT1A1 genotyped patients
UGT1A1 genotyped patients receive CPT-11 with platinum analogues
Intervention: CPT-11 (Drug)
UGT1A1 genotyped patients
UGT1A1 genotyped patients receive CPT-11 with platinum analogues
Intervention: Platinum analogues (Drug)
Outcomes
Primary Outcomes
Number of Participants with UGT1A1 Genotype with Severe Toxicities Induced by CPT-11 with Platinum Analogues
Time Frame: within 6 months
Secondary Outcomes
- Response Rate of Participants with UGT1A1 genotype to CPT-11 with Platinum Analogues(within 6 months)
- Duration of Response to CPT-11 with Platinum Analogues in Participants with UGT1A1 Genotype(within 6 months)
Investigators
Study Sites (1)
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