Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.

Pancreatic Cancer Clinical Trial

Official title:

An Open, Multiple Dose, Single Centre Study to Determine the Antibody Response to G17DT in Patients With Advanced Pancreatic Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098239
• Other study ID #: PC2
• Status: Completed
• Phase: Phase 2
• First received: March 25, 2014
• Last updated: March 25, 2014
• Start date: August 1999
• Est. completion date: May 2002

Study information

• Verified date: March 2014
• Source: Cancer Advances Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study was designed to assess the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advances pancreatic cancer.

Description:

Jaundiced patients with advanced pancreatic cancer (either locally, advanced or metastatic) were treated with G17DT either immediately (Group A), or following biliary stenting when jaundice had resolved (Group B). Patients not jaundiced at time of presentation were to enter Group B. Patients received 3 Intramuscular injections of G17DT at weeks 0, 1, and 3. A booster injection was offered to patients who had measurable anit-G17Dt antibodies but had anti-G17DT antibodies that fell below a pre-specified threshold after week 23. Patients were evaluated until study closure ort until patient death.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2002
• Est. primary completion date: April 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with a pancreatic adenocarcinoma (cytologically or histologically proven), not suitable for a potentially curative resection.

• If patients were jaundiced, bilirubin had to be >80 µmol/L.

• Male or female patients over 18 years of age.

• World Health Organization (WHO) performance status of 0 to 2.

• Patients with a life expectancy of at least 8 weeks.

• Patients must have given written informed consent.

Exclusion Criteria:

• Patients undergoing a potentially curative resection.

• Jaundiced patients with a bilirubin value <80 µmol/L.

• Patients not considered fit for endoscopic or percutaneous biliary stenting.

• Patients receiving any other anti-cancer therapy.

• History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the cervix.

• Females who were pregnant, planning to become pregnant, or who were lactating.

• Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study.

• Previous G17DT treatment.

• Haematological indicators:

Haemoglobin (Hb) <10.0 g/dL. White cell count (WCC) <4.0×109/L. Platelets <100×109/L.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaundice
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• G17DT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Advances Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamic	Gastrin-17 antibodies were measured at baseline (Week 0) and measured at each post-treatment visit.	Weeks 0, 1,3,4,6,8,12, 16+	No
Primary	Patient Survival	The vital status of patients was monitored throughout the study and was followed until death or the end of the study.	Up to week 139	No
Secondary	Injection Tolerability	Tolerability was assessed by injection site during first 16 weeks after the first injection.	Up to Week 16	No