Nab-pacliatxel Plus Gemcitabine in Korean Patients With Metastatic Pancreatic Ductal Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT02426281|
Recruitment Status : Recruiting
First Posted : April 24, 2015
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Ductal Adenocarcinoma||Drug: nab-paclitaxel Drug: gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study to Evaluate the Safety and Efficacy of Nab-pacliatxel Plus Gemcitabine in Korean Patients With Metastatic Pancreatic Ductal Adenocarcinoma|
|Actual Study Start Date :||June 4, 2015|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: nab-paclitaxel in combination with gemcitabine
nab-paclitaxel in combination with gemcitabine nab- paclitaxel 125mg/m2 in combination with gemcitabine 1000mg/m2 D1, 8 15 every 4 weeks.
nab- paclitaxel 125mg/m2 D1, 8 15 every 4 weeks.
gemcitabine 1000mg/m2 D1, 8 15 every 4 weeks.
- progression-free survival (PFS) [ Time Frame: 4 months ]The primary endpoint of the study is progression-free survival (PFS) defined as time to progression or death, whichever comes first.
- overall survival (OS) [ Time Frame: 4 months ]Survival will be measured as the time from the day 1 of first chemotherapy to the date of death.
- Response rate [ Time Frame: 4 months ]Percentage of response is complete response (CR) or partial response (PR) is defined as the period is maintained.
- Disease control rate [ Time Frame: 4 months ]Percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents
- toxicities (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) [ Time Frame: 4 months ]Toxicities as measured by Adverse Events(AEs) and Laboratory Results . The severity / intensity of AEs will be graded based upon the subject's symptoms according to the current active minor version of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)
- Tumor Markers (CA19-9 test) [ Time Frame: 4 months ]Tumor Markers as measured by CA19-9 test.
- Quality of life questionnaire [ Time Frame: 4 months ]Quality of life will be evaluated for nab-paclitaxel in combination with gemcitabine using the EORTC-QLQ-30 and EORTC QLQ- PAN26 questionnaires.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426281
|Contact: Park joon oh, MD,Ph.D.||2-3410-3459 ext email@example.com|
|Korea, Republic of|
|Samsungj Medical Center||Recruiting|
|Seoul, Korea, Republic of, 06351|
|Contact: sungu park 82-2-3410-6820|