NCT00969033 is a Phase 2 clinical trial of CS-1008 in Metastatic Colorectal Cancer, sponsored by Daiichi Sankyo.

Who is sponsoring NCT00969033?

NCT00969033 is sponsored by Daiichi Sankyo.

What drugs are being tested in NCT00969033?

Interventions in NCT00969033: CS-1008, irinotecan.

What condition does NCT00969033 study?

NCT00969033 studies Metastatic Colorectal Cancer.

Is NCT00969033 still recruiting?

NCT00969033 is currently terminated. Last updated 30 January 2012.

Last reviewed 2012-01-30 · How we verify

NCT00969033

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2 Open-label Randomized, Controlled Trial of CS-1008 in Combination With Irinotecan Versus Irinotecan Alone in Subjects With Metastatic Colorectal Carcinoma Who Failed First-line Oxaliplatin Based Regimen

Terminated Phase 2 Last updated 30 January 2012

What this trial tests

Phase 2 trial testing CS-1008 in Metastatic Colorectal Cancer in 8 participants. Terminated before completion.

Timeline

1 July 2009

Primary endpoint
1 December 2011

1 December 2011

Quick facts

Lead sponsor	Daiichi Sankyo
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	1 July 2009
Primary completion	1 December 2011
Estimated completion	1 December 2011
Sites	9 locations across United Kingdom

Drugs / interventions tested

CS-1008 — full drug profile →
irinotecan (irinotecan) — full drug profile →

Conditions studied

Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →

Sponsor

Daiichi Sankyo — full company profile →

Who can join

18 and older, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Determine the difference in progression-free survival (PFS) for CS-1008 administered in combination with irinotecan and irinotecan alone.
Time frame: 1 year

Sponsor's own description

The purpose of this study is to determine the effect of CS-1008 in combination with irinotecan compared to irinotecan alone on Progression-Free Survival (PFS) in subjects with metastatic or advanced colorectal cancer (CRC) who have failed oxaliplatin-based first-line treatment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Death receptors as targets in cancer.
Micheau O, Shirley S, Dufour F. · · 2013 · cited 151× · PMID 23638798 · DOI 10.1111/bph.12238
Principles of antibody-mediated TNF receptor activation.
Wajant H. · · 2015 · cited 111× · PMID 26292758 · DOI 10.1038/cdd.2015.109

Verify or expand the search:

Other trials of CS-1008

Trials testing the same drug.

NCT01220999 — A Phase I Imaging and Pharmacodynamic Trial of CS-1008 in Patients With Metastatic Colorectal Cancer · Phase 1 · completed
NCT00945191 — Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer · Phase 2 · completed

Other recruiting trials for Metastatic Colorectal Cancer

Currently open trials in the same condition.

NCT07416552 — A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC) · Phase 1 · recruiting
NCT07314294 — Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients · Phase 2 · recruiting
NCT06856837 — - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Misma · Phase 2 · recruiting
NCT06959550 — Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorect · Phase 2 · recruiting
NCT06808685 — Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie · recruiting

Other Daiichi Sankyo trials

Trials by the same sponsor.

NCT07474649 — A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events · Phase 3 · not yet recruiting
NCT07206472 — A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholestero · active not recruiting
NCT07220616 — A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies · Phase 1, PHASE2 · recruiting
NCT07268625 — Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorv · Phase 1 · completed
NCT07244341 — A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer ( · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00969033 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Daiichi Sankyo
Last refreshed: 30 January 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00969033.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing