An Open Label Study to Evaluate G17DT Compared to Gemcitabine

NCT03200821 | Completed Phase 3 FDA Drug

• 1 other identifier: PC3
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Survival

  Survival in days measured starting at Baseline

  Baseline (Week 0) up to Week 52 or death.

Secondary Outcomes (5)

• Tumor Response

  Weeks 0, 12, 24, 36 and 52

• Quality of Life

  Weeks 0, 6, 12, 24, 36 and 52

• Quality of Life

  Weeks 0, 6, 12, 24, 36 and 52

• Karnofsky Performance Status

  Week 0 to Week 52

• Gastrin-17 Antibodies

  Weeks 0, 6, 12, 24, 36 and 52

Study Arms (2)

G17DT

EXPERIMENTAL

250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.

Biological: G17DT

Gemcitabine

ACTIVE COMPARATOR

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

Interventions

G17DT BIOLOGICAL

250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.

Also known as: PAS, Polyclonal Antibody Stimulator

G17DT

Gemcitabine DRUG

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.

Also known as: Gemzar

Gemcitabine

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Advances Inc.: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, open, parallel group, active comparator

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 27, 2017
• Study Start: August 14, 2000
• Primary Completion: September 24, 2001
• Study Completion: September 19, 2002
• Last Updated: June 27, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share