EUCTR2017-003621-15-IT
Active, not recruiting
Phase 1
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
Conditionsadvanced pancreatic cancerMedDRA version: 21.0Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsHALAVEN - 0.44MG/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO(VETRO) 2ML 6 FLACONCINICAPECITABINA ACCORD - 150 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) - 120 COMPRESSECAPECITABINA ACCORD - 500 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) - 120 COMPRESSE
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- advanced pancreatic cancer
- Sponsor
- AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
- Enrollment
- 25
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 2
Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer.Advanced/recurrent HER2-positive breast cancerJPRN-UMIN000011020Sairtama Breast Cancer Clinical Study Group (SBCCSG)na35
Completed
Phase 2
A phase II study of eribulin in combination with trastuzumab and pertuzumab as First-Line therapy for metastatic HER2-positive breast cancerFirst-Line therapy for metastatic HER2-positive breast cancer.JPRN-UMIN000021585Sairtama Breast Cancer Clinical Study Group (SBCCSG)16
Completed
Phase 2
A phase 2 study of eribulin in combination with pertuzumab and trastuzumab for advanced or recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancerJPRN-UMIN000014107SONG (South Osaka Network Group for Breast Cancer)43
Completed
Not Applicable
A Phase II Study of Eribulin Evaluating Efficacy and Safety as first or secondary line chemotherapy for advanced or metastatic breast cancer without HER2 overexpressingAdvanced or metastatic breast cancerJPRN-UMIN000009568General and Gastroenterological Surgery, Osaka Medical College35
Active, not recruiting
Phase 1
A clinical trial to look at the safety and possible benefit, of alternating the drug eribulin with an Aromatase Inhibitor, in patients with pre-treated oestrogen receptor positive (ER+ve) breast cancer.Patients with locally advanced or metastatic oestrogen receptor positive (ER+ve) breast cancer who have received at least one hormonal therapy and at least one chemotherapy in the metastatic setting.MedDRA version: 18.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2014-004112-11-GBImperial College London12