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An Open Label Study to Evaluate G17DT Compared to Gemcitabine | Clinical Trials | Clareo Health

COMPLETEDPHASE3

An Open Label Study to Evaluate G17DT Compared to Gemcitabine

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

NCT03200821•Cancer Advances Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

August 14, 2000

Primary Completion Date

September 24, 2001

Completion Date

September 19, 2002

Last Updated

June 27, 2017

Enrollment

103

ACTUAL participants

Conditions

Pancreatic Cancer

Interventions

G17DT

BIOLOGICAL

Gemcitabine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Open Label Study to Evaluate G17DT Compared to Gemcitabine

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

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PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples

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