NCT00056459 is a Phase 3 clinical trial of Vatalanib in Colorectal Neoplasms, sponsored by Novartis.

Who is sponsoring NCT00056459?

NCT00056459 is sponsored by Novartis.

What drugs are being tested in NCT00056459?

Interventions in NCT00056459: Vatalanib.

What condition does NCT00056459 study?

NCT00056459 studies Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms.

Is NCT00056459 still recruiting?

NCT00056459 is currently completed. Last updated 6 February 2020.

Last reviewed 2020-02-06 · How we verify

NCT00056459

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

A Randomized, Double-blind, Placebo-controlled, Phase Lll Study in Patients With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First-line Chemotherapy With Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo

Completed Phase 3 Last updated 6 February 2020

What this trial tests

Phase 3 trial testing Vatalanib in Colorectal Neoplasms in 1,168 participants. Completed.

Timeline

1 February 2003

Primary endpoint
1 January 2007

Quick facts

Lead sponsor	Novartis
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,168
Start date	1 February 2003
Primary completion	1 January 2007
Sites	223 locations across United States, Australia, Belgium, Brazil, Canada, Czechia, France, Germany

Drugs / interventions tested

Vatalanib — full drug profile →

Conditions studied

Colorectal Neoplasms — all drugs for Colorectal Neoplasms →
Colonic Neoplasms — all drugs for Colonic Neoplasms →
Rectal Neoplasms — all drugs for Rectal Neoplasms →

Sponsor

Novartis — full company profile →

Who can join

18 and older, any sex, with Colorectal Neoplasms or Colonic Neoplasms. 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.

Progression free survival
Time frame: Throughout duration of study

Sponsor's own description

To compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and are seeking first chemotherapy treatment

Publications & conference data

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

Comprehensive review of targeted therapy for colorectal cancer.
Xie YH, Chen YX, Fang JY. · · 2020 · cited 1162× · PMID 32296018 · DOI 10.1038/s41392-020-0116-z
Therapeutic advances of targeting receptor tyrosine kinases in cancer.
Tomuleasa C, Tigu AB, Munteanu R, Moldovan CS, et al · · 2024 · cited 133× · PMID 39138146 · DOI 10.1038/s41392-024-01899-w
Randomized, placebo-controlled, phase III study of first-line oxaliplatin-based chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma.
Hecht JR, Trarbach T, Hainsworth JD, Major P, et al · · 2011 · cited 129× · PMID 21464406 · DOI 10.1200/jco.2010.29.4496
Molecular mechanisms targeting drug-resistance and metastasis in colorectal cancer: Updates and beyond.
Al Bitar S, El-Sabban M, Doughan S, Abou-Kheir W. · · 2023 · cited 53× · PMID 36998426 · DOI 10.3748/wjg.v29.i9.1395
Colorectal Cancer: From Genetic Landscape to Targeted Therapy.
El Bali M, Bakkach J, Bennani Mechita M. · · 2021 · cited 29× · PMID 34326875 · DOI 10.1155/2021/9918116
Systematic bias between blinded independent central review and local assessment: literature review and analyses of 76 phase III randomised controlled trials in 45 688 patients with advanced solid tumour.
Zhang J, Zhang Y, Tang S, Jiang L, et al · · 2018 · cited 23× · PMID 30206071 · DOI 10.1136/bmjopen-2017-017240
Anti-angiogenic therapies for metastatic colorectal cancer: current and future perspectives.
Marques I, Araújo A, de Mello RA. · · 2013 · cited 20× · PMID 24307789 · DOI 10.3748/wjg.v19.i44.7955
Deciphering treatment resistance in metastatic colorectal cancer: roles of drug transports, EGFR mutations, and HGF/c-MET signaling.
Albadari N, Xie Y, Li W. · · 2023 · cited 16× · PMID 38269272 · DOI 10.3389/fphar.2023.1340401

Verify or expand the search:

Other recruiting trials for Colorectal Neoplasms

Currently open trials in the same condition.

NCT06983639 — Randomized Trial Comparing Fecal Testing (FIT) to Colonoscopy for Post-polypectomy Surveillance · NA · recruiting
NCT07222800 — Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult · Phase 3 · recruiting
NCT07239479 — DEXDES Trial: Dexmedetomidine-Desflurane Combination in Laparoscopic Colectomy · NA · recruiting
NCT07262840 — Health Behavior Change in High-Risk Colorectal Cancer Individuals · NA · recruiting
NCT07257653 — The Safety and Efficacy of Cetuximab Beta Plus Fruquintinib With or Without Immune Checkpoint Inhibitorrs in First-line · Phase 2 · recruiting

Other Novartis trials

Trials by the same sponsor.

NCT06595069 — A Real-world Study to Assess the Characteristics and Long-term Effectiveness of Inclisiran in Chinese Adult Patients · completed
NCT06632730 — Therapeutic Management and Use of Resources and Costs of Spinal Muscular Atrophy in Spain · completed
NCT06395909 — A Study to Assess the Effectiveness and Safety of Mayzent in Chinese Patients With Relapsing Forms of Multiple Sclerosis · completed
NCT06516029 — Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Ascimini · completed
NCT06644638 — Real-World Persistence and Adherence of Ofatumumab Compared to Self-Injectable and Oral DMTs in Patients With Multiple S · completed

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 NCT00056459 (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 Novartis
Last refreshed: 6 February 2020

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/NCT00056459.

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