A Phase I/II Study of Topical SOR007 in Patients with Skin Metastases from Cancer

Full Title

SOR007-2017-01: Phase 1/2 Dose-Rising, Safety, Tolerability and Efficacy Study of Topical SOR007 for Cutaneous Metastases

Purpose

The purpose of this study is to find the highest dose of the investigational drug SOR007 that can be used safely in patients with cancer that has spread to the skin (“cutaneous metastases”). SOR007 is a new form of the chemotherapy drug paclitaxel that is applied directly to the skin as an ointment. Paclitaxel interferes with the development of cancer cells, slowing their growth and their ability to spread throughout the body. Paclitaxel is approved by the FDA for intravenous infusion in patients with breast, lung, ovarian, and other cancers.

Eligibility

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

  • Patients must have cutaneous metastases from breast, lung, head and neck, pancreatic, urinary bladder, prostate, testicular, ovarian, uterine, cervical, gastric, adrenal, thyroid, or parathyroid cancers or other solid tumors.
  • At least 4 weeks must pass since the completion of prior taxane chemotherapy and any radiotherapy, intralesional therapy, laser therapy surgery (other than biopsy) to the target area, local hyperthermia, levulinic acid, 5-fluorouracil, high-potency corticosteroids (including systemic steroids), retinoids, diclofenac, hyaluronic acid, or imiquimod.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mario Lacouture at 646-888-6014.

Protocol

18-192

Phase

I/II

Investigator

Co-Investigators