Trials / Completed
CompletedNCT03200821
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 103 (actual)
- Sponsor
- Cancer Advances Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | G17DT | 250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24. |
| 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. |
Timeline
- Start date
- 2000-08-14
- Primary completion
- 2001-09-24
- Completion
- 2002-09-19
- First posted
- 2017-06-27
- Last updated
- 2017-06-27
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03200821. Inclusion in this directory is not an endorsement.