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

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 II study, single-arm with eribulin + capecitabine after gemcitabine / abraxane failure in pati

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003621-15-IT

Enrollment

Registered

2021-06-17

Start date

2018-01-22

Completion date

Unknown

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced pancreatic cancer MedDRA version: 21.0 Level: LLT Classification code 10033599 Term: Pancreatic adenocarcinoma metastatic System Organ Class: 100000004864

Interventions

Trade Name: HALAVEN - 0.44MG/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO(VETRO) 2ML 6 FLACONCINI Product Name: HALAVEN Product Code: [-] Pharmaceutical Form: Solution for infusion Current

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age =18 and =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Progression rate after 3 months of treatment 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 combination with capecitabine, as measured by the rate of progression after three months of treatment based on local investigator’s assessment according to RECIST v1.1;Timepoint(s) of evaluation of this end point: after three months	—

Measure

Time frame

Main Objective: Progression rate after 3 months of treatment 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 combination with capecitabine, as measured by the rate of progression after three months of treatment based on local investigator’s assessment according to RECIST v1.1;Timepoint(s) of evaluation of this end point: after three months

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Secondary

Measure	Time frame
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 every 6 months after progression of the disease	—

Measure

Time frame

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 every 6 months after progression of the disease

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Countries

European Union, Italy

Contacts

Public ContactClinical Trial Quality Team

Servizio Formazione, Ricerca e Innovazione

ricercainnovazione@policlinico.mo.it0594224369

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026