A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer (FRIDA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02370238|
Recruitment Status : Active, not recruiting
First Posted : February 24, 2015
Last Update Posted : July 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: paclitaxel Drug: Reparixin Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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)|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||February 2019|
paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + reparixin oral tablets 1200 mg t.i.d.
continuing from D 1 to Day 21 of 28-day cycle
paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15)
reparixin oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle
Active Comparator: paclitaxel+placebo
paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15) + placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle
paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15)
placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle
- Progression Free Survival (PFS) [ Time Frame: 18 months ]Defined as the number of days between the date of randomization and the date of clinical disease progression (PD)
- Median PFS (mPFS) [ Time Frame: 18 months ]Median PFS (mPFS) defined as the number of days between the date of randomization and the date of clinical disease progression (PD) according to RECIST criteria version 1.1
- Overall Survival [ Time Frame: 18 months ]Overall Survival defined as the interval (days) between randomization and death from any cause.
- Objective Response Rate [ Time Frame: 18 months ]Objective response rates (ORR) defined as the percentage of the patients reaching complete remission (CR), partial remission (PR) or stable disease (SD) according to RECIST criteria version 1.1.
- AE [ Time Frame: during 14 days before start of treatment ]Adverse events
- AE [ Time Frame: Days 1, 8 and 15 of each cycle ]Adverse events
- AST [ Time Frame: Day 1 of each cycle ]aspartate aminotransferase
- ALT [ Time Frame: Day 1 of each cycle ]alanine aminotransferase
- ALP [ Time Frame: Day 1 of each cycle ]alkaline phosphatase
- WBC [ Time Frame: Days 1, 8 and 15 of each cycle ]White cells differential counts
- TTM [ Time Frame: 18 months ]Median Time to new Metastasis (TTM)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370238
|Study Director:||Dompé Milan||Dompé farmaceutici s.p.a. Milan Italy|