A Phase II study of a Combination of Eribulin and capecitabiNe in second line Treatment after the failure of gemcitabine/abraxane first line in advanced pancreatic cancer

Phase 1

• Conditions: advanced pancreatic cancer; MedDRA version: 21.0Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003621-15-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

age =18 and < 75 years
Histologically/cytologically confirmed advanced, unresectable pancreatic cancer
Patients Resistant/refractory to a first line chemotherapy including nab-paclitaxel/gemcitabine
Willing and able to comply with all aspects of the protocol
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 at study entry
Life expectancy of at least 3 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Previous chemotherapy with capecitabine or 5fluorouracil within 6 months of study entry
Evidence of clinically symptomatic CNS metastases
Patients with only non measurable disease according to RECIST 1.1 criteria
Treatment with chemotherapy or any anti-cancer drug within 3 weeks of the study entry

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Progression rate after 3 months of treatment<br>Safety (NCICTC version 4.0);Secondary Objective: Response rate (RECIST version 1.1), PFS and median OS; assessment of reversion from epithelial to mesenchymal cells;Primary end point(s): The primary objectives of this trial is to assess the safety and anti-tumor activity of eribulin in<br>combination with capecitabine, as measured by the rate of progression after three months of treatment<br>based on local investigator’s assessment according to RECIST v1.1;Timepoint(s) of evaluation of this end point: after three months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary efficacy endpoints are: PFS, ORR, OS and the assessment of the potential biological effect of eribulin on the mesenchymal to epithelial cell reversion assessed by plasma exosomes. Response to treatment has to be assessed by using the same techniques performed at baseline. At the end of treatment tumor assessment will be performed every 3 months, during follow up visits until PD, for all patients who goes off study for other reason than PD. After PD, six-month assessment of the patient status (dead or alive; with or without recurrence or second primary tumor) is required.;Timepoint(s) of evaluation of this end point: every 3 months during treatment until disease progression<br>every 6 months after progression of the disease