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COMPLETEDPHASE1

Study of CS-1008 in Combination With FOLFIRI in Patients Who Have Failed Other Treatments

Pilot Study of CS-1008 in Combination With FOLFIRI (Irinotecan, Leucovorin, and 5-fluorouracil [5-FU]) in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Failed First-line Treatment That Was Not Irinotecan-based.

NCT01124630•Daiichi Sankyo

View on ClinicalTrials.gov

Summary

Treatment with CS-1008 in combination with FOLFIRI (irinotecan, leucovorin, and 5-fluorouracil \[5-FU\]) in subjects with metastatic colorectal cancer (CRC) who have failed first-line treatment that was not irinotecan-based.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed, metastatic CRC that has progressed after first-line standard therapy that was not irinotecan-based.
•At least 18 years of age.
•Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2.
•Adequate organ and bone marrow function as evidenced by:
•* Hemoglobin \>= 9 g/dL
•* White blood cell count (WBC) \>= 3.0 x 109/L
•* Absolute neutrophil count (ANC) \>= 1.5 x 109/L
•* Platelet count \>= 100 x 109/L
•* Serum creatinine \< the upper limit of normal (ULN)
•* AST and alkaline phosphatase =\< 2.5 x ULN if without liver metastasis and =\< 5.0 x ULN if liver metastasis
+6 more criteria

Exclusion Criteria

•Anticipation of a need for a major surgical procedure or radiotherapy (RT) during the study.
•Treatment with chemotherapy, hormonal therapy, RT, minor surgery, or any investigational agent within 4 weeks before study enrollment. Treatment with nitrosoureas, mitomycin C, immunotherapy, biological therapy, or major surgery within 6 weeks before study enrollment.
•First-line therapy for CRC that was irinotecan-based.
•History of any of the following conditions within 6 months before study enrollment:
•* Myocardial infarction;
•* Severe/unstable angina pectoris;
•* Coronary/peripheral artery bypass graft;
•* New York Heart Association (NYHA) class III or IV congestive heart failure;
•* Cerebrovascular accident or transient ischemic attack;
•* Pulmonary embolism or other clinically significant thromboembolic event; or
+11 more criteria

Locations (3)

Mayo Clinic

Scottsdale, Arizona, United States

Mayo Clinic

Jacksonville, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

May 1, 2010

Primary Completion Date

July 1, 2013

Completion Date

August 1, 2013

Last Updated

December 3, 2013

Enrollment

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

CS-1008

DRUG

FOLFIRI

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of CS-1008 in Combination With FOLFIRI in Patients Who Have Failed Other Treatments

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

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