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

NCT02098239 | Completed Phase 2

• 1 other identifier: PC2
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Jaundice; Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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+

• 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

Secondary Outcomes (1)

• Injection Tolerability

  Up to Week 16

Study Arms (2)

Group A

ACTIVE COMPARATOR

Jaundiced patients with bilirubin value \>80 μmol/L. Received G17DT immediately prior to biliary stenting.

Drug: G17DT

Group B

ACTIVE COMPARATOR

Patients to be treated following biliary decompression or for immediate treatment if non-jaundiced. Received G17DT 2 weeks after biliary stenting when bilirubin was \<40 μmol/L.

Drug: G17DT

Interventions

G17DT DRUG

Also known as: Polyclonal Antibody Stimulator (PAS)

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Advances Inc.: lead

MeSH Terms

Conditions

Jaundice; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: March 27, 2014
• Study Start: August 1, 1999
• Primary Completion: April 1, 2002
• Study Completion: May 1, 2002
• Last Updated: March 27, 2014

Record last verified: 2014-03