Clinical trialPhase 1Completed
Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab (AV-299) in Patients With Advanced Pancreatic Cancer
Phase 1b Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab (AV-299) in Patients With Advanced Pancreatic Cancer
- Outcome
- Finished, no results posted
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- 17 January 2018
- Expected end
- 29 July 2021
- Enrollment
- 26 participants
- Sites
- 2
- Primary outcomes
- The Maximum Tolerated Dose of ficlatuzumab when administered in combination with gemcitabine and nab-paclitaxel
- Sponsor
- Other
- Results posted
- No
- Last update
- 3 August 2021
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Brief summary public domain (ClinicalTrials.gov)
To identify the maximally tolerated dose of ficlatuzumab when combined with nab-paclitaxel and gemcitabine in patients with previously untreated pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
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.