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An Observational Study of CPT-11 Plus Platinum Analogues Regimens and UGT1A1 Genotypes in Solid Tumors

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Daiichi Sankyo

Status

Completed

Conditions

Gastric Cancer (Inoperable and Recurrent)
Small Cell Lung Cancer
Non-small Cell Lung Cancer
Ovarian Cancer
Cervical Cancer

Treatments

Drug: CPT-11
Drug: Platinum analogues

Study type

Observational

Funder types

Industry

Identifiers

NCT01040312
TOP009-062
090946 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

321 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

321 participants in 1 patient group

UGT1A1 genotyped patients
Description:
UGT1A1 genotyped patients receive CPT-11 with platinum analogues
Treatment:
Drug: Platinum analogues
Drug: CPT-11

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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