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An Open Label Study to Evaluate G17DT Compared to Gemcitabine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200821
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Cancer Advances Inc.

Brief Summary:
In this study 250 µg of G17DT was administered at Weeks 0, 2 and 6 in order to demonstrate non inferiority compared to gemcitabine in prolonging survival in advanced pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: G17DT Drug: Gemcitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, open, parallel group, active comparator
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Study to Evaluate the Efficacy and Safety of 250 µg G17DT or 1000 µg/m^2 Gemcitabine in Subjects With Advanced Pancreatic Cancer
Actual Study Start Date : August 14, 2000
Actual Primary Completion Date : September 24, 2001
Actual Study Completion Date : September 19, 2002

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: G17DT
250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.
Biological: G17DT
250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.
Other Name: PAS, Polyclonal Antibody Stimulator

Active Comparator: Gemcitabine
1000 µg/m^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest.
Drug: Gemcitabine
1000 µg/m^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest.
Other Name: Gemzar




Primary Outcome Measures :
  1. Survival [ Time Frame: Baseline (Week 0) up to Week 52 or death. ]
    Survival in days measured starting at Baseline


Secondary Outcome Measures :
  1. Tumor Response [ Time Frame: Weeks 0, 12, 24, 36 and 52 ]

    The proportion of patients having an objective tumor response using Computed Tomography (CT) and the Response Evaluation Criteria In Solid Tumors (RECIST).

    (RECIST) guidelines


  2. Quality of Life [ Time Frame: Weeks 0, 6, 12, 24, 36 and 52 ]
    Quality of life measured using Cancer Quality of Life Questionnaire EORTC-QLQC30 questionnaire

  3. Quality of Life [ Time Frame: Weeks 0, 6, 12, 24, 36 and 52 ]
    Quality of life measured using and the EORTC QLQ-PAN26 questionnaire

  4. Karnofsky Performance Status [ Time Frame: Week 0 to Week 52 ]
    Functional impairment assessment using the Karnofsky Performance Scale Index

  5. Gastrin-17 Antibodies [ Time Frame: Weeks 0, 6, 12, 24, 36 and 52 ]
    Antibody assessment to determine serum levels of Gastrin -17 antibodies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of pancreatic adenocarcinoma, confirmed by histology or cytology, in patients not suitable for pancreatic tumor resection with curative intent.
  • A diagnosis of recurrent pancreatic adenocarcinoma (previously confirmed by histology or cytology) in patients who have had a primary tumor resection.
  • Male or female patients over 18 years of age.
  • Laboratory values within the following ranges at screening:

Serum creatinine < 1.25 times upper limit of normal (ULN) Haemoglobin > 9.5 g/dL White blood cell (WBC) count > 3.5 x 109/L Platelets > 100 x 109/L Total bilirubin < 2.0 times ULN Aspartate transaminase (AST, SGOT) < 3 times ULN

  • A life expectancy of at least 2 months.
  • A negative pregnancy test at the screening visit (females of childbearing potential only).
  • Signed written informed consent.

Exclusion Criteria:

  • History of other malignant disease (except basal cell carcinoma or in situ carcinoma of the uterine cervix).
  • Previous cytotoxic chemotherapy (including gemcitabine).
  • Previous radiotherapy within 30 days of baseline.
  • Use of systemic (oral or injected) immunosuppressants, including corticosteroids, within 30 days prior to the baseline visit. Inhaled corticosteroids for chronic obstructive pulmonary disease or asthma were permitted.
  • Females of child bearing potential who are pregnant, lactating, or who are planning to become pregnant during the period of the study.
  • Participation in another study involving an investigational drug within 90 days of baseline.
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Responsible Party: Cancer Advances Inc.
ClinicalTrials.gov Identifier: NCT03200821    
Other Study ID Numbers: PC3
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs