Clinical trialPhase 2Completed
Eribulin Mesylate as Second-Line Therapy for Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer Patients
A Phase II Study of the Halichondrin B Analog E7389 as Second Line Therapy for Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- August 2006
- Expected end
- July 2011
- Enrollment
- 15 participants
- Sites
- 1
- Primary outcomes
- Objective Response (Complete and Partial) Evaluated Using RECIST Criteria
- Sponsor
- Nih
- Results posted
- 2016-12-09
- Last update
- 20 October 2017
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Brief summary public domain (ClinicalTrials.gov)
This phase II trial is studying how well E7389 works as second-line therapy in treating patients with locally advanced, unresectable, or metastatic pancreatic cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVE: I. To determine the objective response (complete and partial) to E7389 in patients with locally advanced, unresectable, or metastatic pancreatic adenocarcinoma that progressed after prior gemcitabine hydrochloride-based therapy. SECONDARY OBJECTIVE: I. To determine the antitumor activity of E7389, in terms of median survival, 1-year survival rate, response or stable disease duration, toxicity, and time to disease progression, in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive eribulin mesylate IV on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, all patients are followed at 4 weeks. Patients with complete response, partial response, or stable disease are followed every 3 months.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Objective Response (Complete and Partial) Evaluated Using RECIST Criteria [Up to 3 years]. Number, participants. Treatment (Eribulin Mesylate) (n=15): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Stable Disease Rate, Evaluated Using RECIST Criteria [Up to 3 years]. Number, percentage of participants (95% Confidence Interval). Treatment (Eribulin Mesylate) (n=15): 33 (15 to 59).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Median Survival Time [Up to 3 years]. Median, months (95% Confidence Interval). Treatment (Eribulin Mesylate) (n=15): 6 (1 to 21).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [At 6 months]. Number, percentage of participants (95% Confidence Interval). Treatment (Eribulin Mesylate) (n=15): 58 (25 to 81).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [At 1 year]. Number, participants. Treatment (Eribulin Mesylate) (n=15): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Median Time to Disease Progression [Duration of time from start of treatment until the criteria for progression are met, assessed up to 3 years]. Median, months (95% Confidence Interval). Treatment (Eribulin Mesylate) (n=15): 1.5 (1 to 9).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Progression [At 6 months]. Median, months (95% Confidence Interval). Treatment (Eribulin Mesylate) (n=15): 1.4 (1.2 to 8.5).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Progression [At 1 year].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Response Duration [From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Toxicity [All patients will be evaluable for toxicity from the time of their first treatment with E7389.]. Number, Types of adverse event. E7389 (n=15): 8.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Objective Stable Disease Rate [Upto 3 years].