A Phase Ib Study of PF-04136309 plus Gemcitabine and Nab-Paclitaxel in Patients with Previously Untreated Metastatic Pancreatic Cancer

Full Title

Phase 1b/2 Study of PF-04136309 in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Purpose

Gemcitabine and nab-paclitaxel are drugs used to treat metastatic pancreatic cancer. Researchers want to know if adding the investigational drug PF-04136309 to gemcitabine and nab-paclitaxel increases the effectiveness of treatment.

PF-04136309 works by blocking a signaling pathway called CCR2, which helps pancreatic cancer cells resist the lethal effects of chemotherapy. It is hoped that giving PF-04136309 can activate the immune system against cancer and also reduce chemotherapy resistance, making pancreatic cancer cells more vulnerable to gemcitabine and nab-paclitaxel.

In this part of the study, researchers will assess increasing doses of PF-04136309 to find the highest dose that can be given safely with gemcitabine and nab-paclitaxel. PF-04136309 is taken orally (by mouth), while gemcitabine and nab-paclitaxel are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic pancreatic ductal adenocarcinoma that has not yet been treated.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Maeve Lowery at 646-888-4543.

Protocol

16-800

Phase

I/II

Investigator

Co-Investigators

Locations