A Randomized, Double-blind, Placebo-controlled Phase 2 Study of Paclitaxel in Combination With Reparixin Compared to Paclitaxel Alone as Front-line Therapy for Metastatic Triple- Negative Breast Cancer (FRIDA)

Investigator: Jenny Chang, MD

Study Coordinator: Toniva Boone

Status: Enrolling

ClinicalTrials.gov Number: NCT02370238

Phone: 713.441.0686

Protocol Number: Pro00012738


Reparixin oral tablets are being tested as a CSC targeting agent in patients with metastatic non- human epidermal growth factor receptor (HER2)-amplified BC. An open label Phase 1b clinical study (REP0111) is ongoing (enrollment completed) in five US sites, under IND # 112502, to test safety, tolerability, pharmacokinetics and detect early signs of antitumor activity of increasing doses of reparixin oral tablets in combination with a fixed dose of weekly paclitaxel. The study has demonstrated safety and tolerability of the combination across the three dose levels explored and recorded objective responses in the published range for single agent weekly paclitaxel in the target population. The highest dose level explored (i.e., 1200 mg t.i.d.) was identified as the recommended phase 2 dose. Durable responses have been recorded in patients with TNBC. The current phase 2 study thus aims to evaluate the Progression Free Survival of patients with metastatic TNBC [newly diagnosed metastatic or relapsed following (neo)adjuvant chemotherapy] receiving reparixin in combination with paclitaxel versus paclitaxel alone.
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