Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

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

NCT00967616 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG CS7017
  • DRUG irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI)

Study Locations (18)

Other

  • Instituto FIDES Oncologia y Especialidades Medicas — Buenos Aires
  • CAIPO Centro para la Atencion Integral del Paciente Oncologico — San Miguel de Tucumán
  • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul - PUC-RS — Porto Alegre
  • Instituto Nacional de Cancer INCA — Rio de Janeiro
  • ICAVC — São Paulo
  • Fundacion Arturo Lopez Perez — Santiago
  • Instituto Nacional del Cancer — Santiago
  • Instituto Oncologico Clinica Renaca — Viña del Mar
  • Hospital Nacional Alberto Sabogai Sologuren — Callao
  • Hospital Nacional Dos de Mayo — Lima
  • Oncosalud SAC — Lima
  • Hospital Nacional Dos de Mayo — Lima

California

  • Beverly Hills Cancer Center — Beverly Hills
  • St. Jude Heritage Medical Group — Fullerton

District of Columbia

  • John Marshall — Washington D.C.

Georgia

  • Georgia Cancer Specialists — Atlanta

Maryland

  • Victor Priego — Bethesda

Ohio

  • Gabrail Cancer Center — Canton

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2009-09
Est. Completion 2013-04
Phase Phase 2

Sponsor

Daiichi Sankyo

157 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00967616

The ClinicalTrials.gov registry entry for NCT00967616 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 157 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions — of which CS7017 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00967616 reports 18 study locations spanning 6 distinct geographic areas — top geographies include Other, California, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00967616 about?

NCT00967616 is a clinical study titled "Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy". 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 stud...

What is the current status of trial NCT00967616?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2009-09. Estimated completion is 2013-04.

What conditions does trial NCT00967616 study?

This clinical trial studies the following conditions: Colorectal Cancer, Neoplasms, Colorectal. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00967616?

The interventions under investigation include: CS7017 (DRUG), irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00967616?

This trial is sponsored by Daiichi Sankyo, which has 157 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00967616 being conducted?

This trial has 18 study locations across California, District of Columbia, Georgia, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial