A Phase IA/IB Study of RO5509554 Alone and with Paclitaxel in Patients with Advanced Solid Tumors

Protocol
14-086
Full Title
Open-Label, Multicenter, Dose Escalation Phase Ia/Ib Study with Expansion Phase to Evaluate Safety, Pharmacokinetics and Activity of RO5509554, Administered as an Intravenous Infusion as Monotherapy and in Combination with Paclitaxel in Patients with Advanced Solid Tumors
Phase
I
Purpose

The purpose of this study is to assess the safety and preliminary effectiveness of the investigational drug RO5509554 alone and in combination with paclitaxel in patients with advanced solid tumors. RO5509554 blocks a protein called CSF1-R on white blood cells called M2 macrophages, which cause cancer cells to grow. It is hoped by blocking CSF1-R, RO5509554 may stop cancers from growing.

The patients in this study who will receive RO5509554 alone include those with pigmented villonodular synovitis, tenosynovial giant cell tumor, soft-tissue sarcoma, malignant mesothelioma, ovarian cancer, endometrial cancer, breast cancer, and pancreatic cancer. RO5509554 will be given with paclitaxel in patients with HER2-negative breast cancer.

RO5509554 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 advanced pigmented villonodular synovitis, tenosynovial giant cell tumor, soft-tissue sarcoma, malignant mesothelioma, ovarian cancer, endometrial cancer, breast cancer, or pancreatic cancer that persists despite standard treatment or does not have a standard therapy.
  • At least 4 weeks must have passed since completion of prior therapies (2 weeks since hormonal therapies) and entry into the study.
  • 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 about this study and to inquire about eligibility, please contact the Immunotherapeutics Clinic at 646-888-3359 or Dr. Sandra D’Angelo at 646-888-4159.

Disease(s)
Breast Cancer
Endometrial and other Uterine Cancers: Endometrial Cancer
Mesothelioma
Ovarian Cancer
Sarcomas: Soft Tissue Sarcoma
Solid Tumors
Upper Gastrointestinal: Pancreatic Cancer
Locations