A Phase 1 Trial of Verteporfin Photodynamic Therapy in Unresectable Pancreatic Carcinoma (VERTPAC-01 study) - VERTPAC-01

Phase 1

• Conditions: nresectable pancreatic cancer; MedDRA version: 8.1 Level: LLT Classification code 10033604 Term: Pancreatic cancer

• Registration Number: EUCTR2006-004097-28-GB
• Lead Sponsor: niversity College Hospitals NHS Foundation Trust/ University College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-09
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1.A histopathological/cytological diagnosis of pancreatic carcinoma, which is locally advanced and not amenable to curative surgical resection, or the patient is unfit for or declines surgery.
2.ECOG performance status 0, 1 or 2
3.Estimated life expectancy of at least 12 weeks
4.Age >18 years
5.Women of child-bearing potential with a negative pregnancy test (qualitative serum hCG) prior to study entry AND be using an adequate contraception method, which must be continued for 1 week after PDT
6.Capable of giving written informed consent
7.Adequate biliary drainage (serum bilirubin < 2.5 ULN), with no evidence of active uncontrolled infection (patients on antibiotics are eligible)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Porphyria
2.Previous treatment with curative intent for current disease in the last 4 weeks (ie. Prior resection, radical radiotherapy or chemotherapy)
3.History of active or prior malignancy that will interfere with the response evaluation
4.Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
5.Any psychiatric disorder making reliable informed consent impossible
6.Locally advanced disease involving > 50% circumference of the duodenum or a major artery (hepatic, gastroduodenal) within the treatment area.
7.Metastatic disease
8. Pregnancy or breast-feeding
9.ECOG performance status 3 or 4

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified