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NCT00967616 · ClinicalTrials.gov registry record · Phase 2
Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy
A Phase 2 study of Colorectal Cancer and Neoplasms, Colorectal, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 18
- Study locations
NCT00967616: Completed Phase 2 study of Colorectal Cancer and Neoplasms, Colorectal, sponsored by Daiichi Sankyo.
NCT00967616 is a Phase 2 study of Colorectal Cancer and Neoplasms, Colorectal that has completed, run by Daiichi Sankyo. The registered enrollment target is 100 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (94% lower). The trial reports 18 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00967616, a Phase 2 study of Colorectal Cancer and Neoplasms, Colorectal, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 18
- Study locations
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.
Primary Outcome
Progression-free survival (PFS) was defined as the time from randomization until the first objective evidence of disease progression or death from any cause.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
What the finished NCT00967616 record still lists
NCT00967616 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (94% lower).
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.
NCT00967616 lists 18 locations in 6 states (Other, California, District of Columbia).
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.
What interventions are being tested in trial NCT00967616?
The interventions under investigation include: CS7017 (DRUG), irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI) (DRUG).
Who is sponsoring clinical trial NCT00967616?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
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.
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Where NCT00967616's enrollment target sits among peer trials
100 215th of 381 higher than 162 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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