Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab (AV-299) in Patients With Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT03316599|
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Gemcitabine Drug: Nab-paclitaxel Drug: Ficlatuzumab||Phase 1|
This research study is a Phase I dose-escalation clinical trial. It will test the safety and tolerability of an investigational drug ficlatuzumab when combined with Nab-paclitaxel and Gemcitabine, with the goal of determining the maximally tolerated dose of ficlatuzumab when combined with gemcitabine and nab-paclitaxel.
Ficlatuzumab is a type of drug called a "monoclonal antibody." It is thought to work by targeting hepatocyte growth factor (HGF) which is a HGF-c-Met inhibitor. The activation of the receptor tyroside kinase c-Met via its ligand, HGF, mediates proliferation, motility, and differentiation in a variety of cancers including pancreatic cancer.
Subjects must have a newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer and meet all inclusion/exclusion criteria.
Treatment consists of 4 week treatment cycles. Ficlatuzumab will be administered on day 1 and 15 of each cycle. Nab-paclitaxel and gemcitabine will be administered on days 1,8, and 15.
Subjects continue in study until disease progression, adverse event/toxicity, death or either the subject or sponsor discontinues the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1b Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab (AV-299) in Patients With Advanced Pancreatic Cancer|
|Actual Study Start Date :||January 17, 2018|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||November 30, 2023|
Experimental: Ficlatuzumab + Gemcitabine and Nab-Paclitaxel
Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
Other Name: Gemzar
Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells
Other Name: Abraxane
It is selective recombinant humanized hepatocyte growth factor (HGF) inhibitory immunoglobulin G subclass 1 monoclonal antibody which blocks the MET tyrosine kinase receptor.
- The Maximum Tolerated Dose of ficlatuzumab when administered in combination with gemcitabine and nab-paclitaxel [ Time Frame: 2 years ]Identify maximally tolerated dose of ficlatuzumab when administered in combination with gemcitabine and nab-paclitaxel
- The response rate in this population of patients. [ Time Frame: 2 years ]Determine the number of patients who demonstrate a clinical response assessed by RECIST criteria on imaging to the combination of ficlatuzumab with gemcitabine and nab-paclitaxel.
- The progression free survival in this population of patients. [ Time Frame: 2 years ]Determine the progression free survival derived from the combination of ficlatuzumab with gemcitabine and nab-paclitaxel.
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): NCT03316599
|Contact: Christopher Graham, RNfirstname.lastname@example.org|
|Contact: Victoria Germon, RN||617-632-5960||Victoria_Germon@DFCI.HARVARD.EDU|
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Colin D. Weekes, MD email@example.com|
|Principal Investigator: Colin D Weekes, MD|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Christopher Graham, RN 617-632-5960|
|Principal Investigator: Kim Perez, MD|
|Principal Investigator:||Kimberly Perez, MD||Dana-Farber Cancer Institute|