A Phase 1b/2, Open Label Study of Rebastinib + Paclitaxel Combination for Patients with Advanced or Metastatic Solid Tumors
NCT03601897 is a 2-part open label, Phase 1b/2, multicenter study of Rebastinib (DCC-2036), a novel tyrosine switch control inhibitor, orally administered in combination with Paclitaxel.
- Part 1 evaluated two doses of rebastinib at 50 and 100 mg twice daily in combination with paclitaxel to determine the recommended phase 2 dose (RP2D) in patients with locally advanced or metastatic solid tumors for which paclitaxel is considered appropriate treatment. Part 1 enrollment was completed and the RP2D was determined at rebastinib 50 mg BID in combination with Paclitaxel. Two gynecological carcinosarcoma patients were enrolled and treated at rebastinib + 50 mg BID in combination with paclitaxel and both patients responded to the combination.
- Part 2 has five disease-specific cohorts: triple negative breast cancer, inflammatory breast cancer, platinum-resistant ovarian cancer, endometrial cancer, and gynecological carcinosarcoma (MMMT are allowed) to further evaluate the safety, tolerability, and efficacy of the RP2D. Gynecological carcinosarcoma was later incorporated into the trial after review of preliminary response data from Part 1 as described above. A Simon’s two-stage design will be utilized in Part 2 and up to 18 patients will be enrolled into each cohort. If more than 4 responses are observed, up to 33 patients will be enrolled.
Please see the National Institute of Health’s Clinical Trials.gov site for more information: https://clinicaltrials.gov/ct2/show/NCT03601897
Locations of this multicenter clinical trial:
Alphabetically by state and with Primary Investigator noted
- University of Alabama, Birmingham, AL: Rebecca Arend, MD
- Scripps Health, La Jolla, CA: Sonia Ali, MD
- University of Colorado Denver, Aurora, CO: Jennifer Diamond, MD
- Northwestern University, Chicago, IL: Massimo Cristofanilli, MD
- The University of Kansas, Kansas, KS: Andrea Jewell, MD
- Dana Farber Cancer Institute, Boston, MA: Beth Overmoyer, MD
- MD Anderson Cancer Center at Cooper, Camden, NJ: Ahmed Hussein, MD
- Montefiore Medical Center, Bronx, NY: Sanjay Goel, MD
- Northwell Health, Lake Success, NY: Veena John, MD
- Ohio State University, Columbus, OH: John Hays, MD
- University of Oklahoma, Oklahoma City, OK: Debra Richardson, MD
- Fox Chase Cancer Center, Philadelphia, PA: Christina Chu, MD
- Brown University, Providence, RI: Cara Mathews, MD
- Sarah Cannon Research Institute, Nashville, TN: Erika Hamilton, MD
- MD Anderson, Houston, TX: Filip Janku, MD
- Oncology Consultants, Houston, TX: Ricardo Alvarez, MD