A Phase IB Study of Gemcitabine and Docetaxel with Olaratumab in Patients with Advanced Soft Tissue Sarcoma

Full Title

A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma

Purpose

Gemcitabine and docetaxel are two commonly used anticancer drugs. Olaratumab is a drug used to treat soft tissue sarcoma. In this study, researchers want to find the highest dose of olaratumab that can be given safely with gemcitabine and docetaxel in patients with advanced soft tissue sarcoma which has continued to grow or came back despite prior therapy.

Olaratumab is an antibody. It blocks a biochemical pathway that fuels the growth of sarcoma cells. Other studies have suggested that combining olaratumab with chemotherapy drugs may increase its effectiveness. Olaratumab is 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 locally advanced, inoperable, or metastatic soft tissue sarcoma that cannot be cured with surgery or radiation therapy and has continued to grow or came back.
  • Patients may have had up to two prior regimens of chemotherapy. All prior treatments must have been completed at least 4 weeks before entering the study.
  • Patients may not have previously received any of the study drugs.
  • 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 16 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mark A. Dickson at 646-888-4164.

Protocol

16-400

Phase

I/II

Investigator

Co-Investigators