Trial record 1 of 9 for:
glufosfamide
Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT01954992 |
Recruitment Status :
Recruiting
First Posted : October 7, 2013
Last Update Posted : August 6, 2019
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Sponsor:
Eleison Pharmaceuticals LLC.
Information provided by (Responsible Party):
Eleison Pharmaceuticals LLC.
Tracking Information | |||||
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First Submitted Date ICMJE | September 27, 2013 | ||||
First Posted Date ICMJE | October 7, 2013 | ||||
Last Update Posted Date | August 6, 2019 | ||||
Study Start Date ICMJE | September 2013 | ||||
Estimated Primary Completion Date | March 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: Approximately 3-6 months ] Time from Randomization to death from any cause
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer | ||||
Official Title ICMJE | A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Fluorouracil (5-FU) in Patients With Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine | ||||
Brief Summary | The study is designed to assess whether glufosfamide provides additional survival benefit as compared to bolus 5-FU in patients with metastatic pancreatic cancer who have already progressed or failed therapy on a gemcitabine based first line regimen. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Pancreatic Adenocarcinoma | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
480 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 2021 | ||||
Estimated Primary Completion Date | March 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01954992 | ||||
Other Study ID Numbers ICMJE | EP-GF-301 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Eleison Pharmaceuticals LLC. | ||||
Study Sponsor ICMJE | Eleison Pharmaceuticals LLC. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Eleison Pharmaceuticals LLC. | ||||
Verification Date | August 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |