NCT00440310 is a Phase 3 clinical trial of Talaporfin sodium in Liver Metastases, sponsored by Light Sciences Oncology.

Who is sponsoring NCT00440310?

NCT00440310 is sponsored by Light Sciences Oncology.

What drugs are being tested in NCT00440310?

Interventions in NCT00440310: Talaporfin sodium, Percutaneous placement of device in liver metastases, Interstitial light emitting diodes, FOLFOX4 regimen, FOLFIRI regimen.

What condition does NCT00440310 study?

NCT00440310 studies Liver Metastases, Colorectal Neoplasms, Neoplasm Metastasis, Neoplasm Recurrence, Local.

Is NCT00440310 still recruiting?

NCT00440310 is currently completed. Last updated 28 July 2015.

Are results published for NCT00440310?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-07-28 · How we verify

NCT00440310

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

A Multicenter Multinational Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Treating Colorectal Cancer Patients With Recurrent Liver Metastases Using the Litx™ System Plus Chemotherapy as Compared to Chemotherapy Only

Completed Phase 3 Results posted Last updated 28 July 2015

What this trial tests

Phase 3 trial testing Talaporfin sodium in Liver Metastases in 483 participants. Completed in 1 October 2011.

Timeline

1 February 2007

Primary endpoint
1 May 2011

1 October 2011

Quick facts

Lead sponsor	Light Sciences Oncology
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	483
Start date	1 February 2007
Primary completion	1 May 2011
Estimated completion	1 October 2011
Sites	57 locations across Austria, Bosnia and Herzegovina, Croatia, Germany, India, Italy, Latvia, Poland

Drugs / interventions tested

Talaporfin sodium — full drug profile →
Percutaneous placement of device in liver metastases
Interstitial light emitting diodes
FOLFOX4 regimen
FOLFIRI regimen — full drug profile →

Conditions studied

Liver Metastases — all drugs for Liver Metastases →
Colorectal Neoplasms — all drugs for Colorectal Neoplasms →
Neoplasm Metastasis — all drugs for Neoplasm Metastasis →
Neoplasm Recurrence, Local — all drugs for Neoplasm Recurrence, Local →

Sponsor

Light Sciences Oncology — full company profile →

Who can join

18 and older, any sex, with Liver Metastases or Colorectal 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.

Overall Survival
Time frame: Up to 184 weeks
Time from randomization to death

Sponsor's own description

The purpose of the study is to assess the overall survival and progression free survival of patients treated with Litx™ + chemotherapy versus chemotherapy alone in the treatment of Colorectal Cancer with recurrent liver metastases, and to demonstrate the safety of Litx™ therapy. Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tumor tissue inside the body.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Accomplishments in 2008 in the management of curable metastatic colorectal cancer.
Adam R, Hoti E, Folprecht G, Benson AB. · · 2009 · cited 19× · PMID 20011559

Verify or expand the search:

Other recruiting trials for Liver Metastases

Currently open trials in the same condition.

NCT07225036 — Promoting Immunotherapy Efficacy With Low-Dose Liver RT · NA · recruiting
NCT07033364 — Functional Liver After SBRT · recruiting
NCT07044362 — Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis · NA · recruiting
NCT06311851 — Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases · Phase 1, PHASE2 · recruiting
NCT07053488 — CRISPR-Edited HLA Donor Liver Transplant to Reduce Rejection · Phase 1, PHASE2 · 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 NCT00440310 (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 Light Sciences Oncology
Last refreshed: 28 July 2015

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/NCT00440310.

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