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An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma (PC1)

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
G17DT
Sponsored by
Cancer Advances Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent
  • Patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study
  • Male or female patients over 18 years of age
  • Patients with a life expectancy of at least 2 months
  • Patients must have given written informed consent
  • Patients with a Karnofsky Performance Status score of ≥ 50%
  • Patients who would not receive chemotherapy in the period of the Extension Survival Study, except for concomitant gemcitabine ongoing at visit (for extension study)

Exclusion Criteria:

  • History of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix
  • Concomitant use or anticipated use in the period of the study of radiotherapy
  • Chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study
  • Use in the past month or concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
  • Females who were pregnant, planning to become pregnant or lactating
  • Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study
  • Haematological indicators:

Haemoglobin <9.5g/dl White blood cell count <3.5 x 109/l Platelets <100 x 109/l

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    G17DT

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pharmacodynamic
    Anti-Gastrin 17 antibodies were determined at baseline (week0) and measured at subsequent visits during the first 16 weeks after the first G17DT injection to determine the effect of jaundice on the ability of patients to generate antibodies.

    Secondary Outcome Measures

    Patient Survival
    The vital status was monitored throughout the study and was followed up to the death of the last patient.
    Number of Participants with Serious and Non-Serious Adverse Events
    Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-exisiting illnesses, were assessed at each visit.

    Full Information

    First Posted
    March 12, 2014
    Last Updated
    March 26, 2014
    Sponsor
    Cancer Advances Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02098291
    Brief Title
    An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma
    Acronym
    PC1
    Official Title
    Phase II, Open, Single-center Study to Determine the Antibody Response to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1999 (undefined)
    Primary Completion Date
    July 2001 (Actual)
    Study Completion Date
    February 2002 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cancer Advances Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This study was designed to determine the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advanced pancreatic cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    G17DT
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    G17DT
    Primary Outcome Measure Information:
    Title
    Pharmacodynamic
    Description
    Anti-Gastrin 17 antibodies were determined at baseline (week0) and measured at subsequent visits during the first 16 weeks after the first G17DT injection to determine the effect of jaundice on the ability of patients to generate antibodies.
    Time Frame
    Up to week 16
    Secondary Outcome Measure Information:
    Title
    Patient Survival
    Description
    The vital status was monitored throughout the study and was followed up to the death of the last patient.
    Time Frame
    Up to week 139
    Title
    Number of Participants with Serious and Non-Serious Adverse Events
    Description
    Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-exisiting illnesses, were assessed at each visit.
    Time Frame
    Up to week 60

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent Patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study Male or female patients over 18 years of age Patients with a life expectancy of at least 2 months Patients must have given written informed consent Patients with a Karnofsky Performance Status score of ≥ 50% Patients who would not receive chemotherapy in the period of the Extension Survival Study, except for concomitant gemcitabine ongoing at visit (for extension study) Exclusion Criteria: History of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix Concomitant use or anticipated use in the period of the study of radiotherapy Chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study Use in the past month or concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids Females who were pregnant, planning to become pregnant or lactating Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study Haematological indicators: Haemoglobin <9.5g/dl White blood cell count <3.5 x 109/l Platelets <100 x 109/l

    12. IPD Sharing Statement

    Learn more about this trial

    An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma

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