Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT01954992 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

StatusRecruiting
PhasePhase 3
Started2014-04
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 8 months later Jun 2026 → Mar 2028
See other at-risk trials from Eleison Pharmaceuticals LLC.

Amendment history

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
2026-10-06
Primary completion pushed: 2026-06 → 2028-03
Completion pushed: 2026-12 → 2028-06
Eligibility criteria-98 characters
Inclusion Criteria: * At least 18 years of age * Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided) * Metastatic pancreatic cancer * Disease progression during or after treatment with gemcitabi [...] with other agents; at regular, not radiosensitizing, doses) * Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion) * Recovered from reversible toxicities of prior therapy * ECOG performance status 0-1 * All women of childbearing potential and all men must agree t [...] study through 6 months after the last do [...]
Study sitescontacts updated at 1 of 3 sites
2024-12-30
Study Status v11
Primary completion date2025-06→2026-06
Completion date2025-12→2026-12
2023-10-11
Study Status, Contacts/Locations v10
Primary completion date2022-12→2025-06
Completion date2023-03→2025-12
Study sites22→3
2021-05-06
Study Status v9
Primary completion date2021-03→2022-12
Completion date2021-06→2023-03
Start date2013-09→2014-04
2019-08-05
Study Status v8
Primary completion date2019-06→2021-03
Completion date2019-09→2021-06
Show 6 earlier versions
2018-02-05
Study Status v7
Primary completion date2018-09→2019-06
Completion date2018-12→2019-09
2017-02-23
Study Status, Contacts/Locations v6
Primary completion date2017-05→2018-09
Completion date2017-12→2018-12
Study sites30→22
2016-01-19
Study Status, Contacts/Locations v5
Primary completion date2016-12→2017-05
Completion date2017-05→2017-12
Study sites31→30
2015-02-23
Study Status, Conditions, Contacts/Locations v4
Primary completion date2015-04→2016-12
Completion date2015-05→2017-05
Study sites19→31
2014-09-04
Study Status, Contacts/Locations v3
Study sites7→19
2014-04-23
Study Status, Eligibility, Contacts/Locations v2
Study sites1→7
Eligibility criteria+33 characters
[...] 2.5-fold above ULN (>5-fold above ULN if liver metastases) Phosphorus < LLN Potassium < LLN Serum creatinine > 2 mg/dL Creatinine clearance < 60 mL/min [...]
2013-09-27
Original filing
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.
Trial Details
NCT Number NCT01954992
Lead Sponsor Eleison Pharmaceuticals LLC.
Conditions Metastatic Pancreatic Adenocarcinoma
Enrollment 480 participants
Start Date 2014-04
Primary Completion 2028-03 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-10-07