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Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy

Randomized, Active-Controlled, Open-Label Phase 2 Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy

NCT00967616•Daiichi Sankyo

View on ClinicalTrials.gov

Summary

This phase 2, randomized, active-controlled, open-label, parallel group, multicenter study will be conducted at up to 18 study centers in the US, Central America, and South America. Adult subjects with metastatic colorectal cancer (CRC) who failed first-line chemotherapy will participate in the study, which will be conducted on an outpatient basis. It is anticipated that 100 subjects will be enrolled to obtain approximately 90 evaluable subjects.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Metastatic CRC that has progressed following first-line therapy.
•Measurable disease (Response Evaluation Criteria in Solid Tumors \[RECIST\], Version 1.0.
•Male or female ≥ 18 years of age.
•Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
•Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 3.0, grade ≤ 1.
•Adequate organ and bone marrow function as evidenced by:
•* Hemoglobin ≥ 9 g/dL (transfusion and/or growth factor support allowed)
•* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
•* Platelet count ≥ 100 x 10\^9/L
•* Serum creatinine ≤ 1.5 x the upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min
+6 more criteria

Exclusion Criteria

•First-line treatment with an irinotecan-based regimen (eg, FOLFIRI).
•Anticipation of need for a major surgical procedure or radiation therapy (RT) during the study.
•Treatment with chemotherapy, other thiazolidinediones (TZD), RT, surgery, immunotherapy, biological therapy, or any investigational anticancer agent within 4 weeks before start of study treatment.
•History of any of the following conditions within 6 months before initiating study treatment:
•* Diabetes mellitus requiring treatment with insulin or TZD agents
•* Myocardial infarction with significant impairment of cardiac function (eg, ejection fraction ≤ 50%)
•* Severe/unstable angina pectoris
•* Coronary/peripheral artery bypass graft
•* New York Heart Association (NYHA) class III or IV congestive heart failure
•* Malabsorption syndrome, chronic diarrhea (lasting \> 4 weeks), inflammatory bowel disease, or partial bowel obstruction.
+10 more criteria

Locations (18)

Beverly Hills Cancer Center

Beverly Hills, California, United States

St. Jude Heritage Medical Group

Fullerton, California, United States

John Marshall

Washington D.C., District of Columbia, United States

Georgia Cancer Specialists

Atlanta, Georgia, United States

Victor Priego

Bethesda, Maryland, United States

Gabrail Cancer Center

Canton, Ohio, United States

Instituto FIDES Oncologia y Especialidades Medicas

Buenos Aires, Argentina

CAIPO Centro para la Atencion Integral del Paciente Oncologico

San Miguel de Tucumán, Argentina

Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul - PUC-RS

Porto Alegre, Brazil

Instituto Nacional de Cancer INCA

Rio de Janeiro, Brazil

Key Dates

Start Date

September 1, 2009

Primary Completion Date

April 1, 2013

Completion Date

April 1, 2013

Last Updated

May 4, 2020

Enrollment

100

ACTUAL participants

Conditions

Colorectal CancerNeoplasms, Colorectal

Interventions

CS7017

DRUG

irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI)

DRUG

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RECRUITINGPHASE1

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

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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: May 4, 2020Data 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.

View ClinicalTrials.gov Terms and Conditions

Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

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

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease