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A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer (FRIDA)

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ClinicalTrials.gov Identifier: NCT02370238
Recruitment Status : Completed
First Posted : February 24, 2015
Results First Posted : June 2, 2021
Last Update Posted : June 2, 2021
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Dompé Farmaceutici S.p.A

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Interventions Drug: paclitaxel
Drug: Reparixin
Drug: placebo
Enrollment 194
Recruitment Details Of the 194 enrolled patients, 123 were randomized and included in the ITT Population: 62 patients in Group 1 and 61 patients in Group 2.
Pre-assignment Details Due to extreme enrollment difficulties during the first 6 months of 2018, enrollment to the study was terminated early (30 July 2018) and the final sample size is equal to 123 randomized patients.
Arm/Group Title Paclitaxel+Reparixin (Group 1) Paclitaxel+Placebo (Group 2)
Hide Arm/Group Description

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.

Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

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.

Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

Period Title: Overall Study
Started 62 61
ITT Population 62 61
Safety Population 61 60
Responsable-evaluable Population 57 54
Completed 15 16
Not Completed 47 45
Reason Not Completed
Death             42             35
Lost to Follow-up             1             3
Withdrawal by Subject             2             6
Other             2             1
Arm/Group Title Paclitaxel+Reparixin (Group 1) - Safety Population Paclitaxel+Placebo (Group 2) - Safety Population Total
Hide Arm/Group Description

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.

Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

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.

Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

Total of all reporting groups
Overall Number of Baseline Participants 61 60 121
Hide Baseline Analysis Population Description
The Safety Population consisted of 121 patients who took at least one dose of study treatment
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 60 participants 121 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
44
  72.1%
44
  73.3%
88
  72.7%
>=65 years
17
  27.9%
16
  26.7%
33
  27.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 60 participants 121 participants
Female
61
 100.0%
60
 100.0%
121
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 60 participants 121 participants
Hispanic or Latino
3
   4.9%
2
   3.3%
5
   4.1%
Not Hispanic or Latino
48
  78.7%
54
  90.0%
102
  84.3%
Unknown or Not Reported
10
  16.4%
4
   6.7%
14
  11.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 60 participants 121 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.7%
1
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   9.8%
6
  10.0%
12
   9.9%
White
45
  73.8%
49
  81.7%
94
  77.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
10
  16.4%
4
   6.7%
14
  11.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 60 participants 121 participants
Belgium 4 6 10
United States 15 19 34
Czechia 3 8 11
Poland 6 3 9
Italy 16 12 28
France 10 4 14
Spain 7 8 15
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description

PFS was defined as the number of days between the date of randomization and the date of clinical disease progression, according to RECIST criteria version 1.1, as assessed by Independent Radiology Review, or to death due to any cause, whichever occurred first.

Patients must have completed at least one course of treatment and performed at least one disease assessment to be considered evaluable for response.

Time Frame Baseline up to every 8 weeks until disease progression or death, whichever occurs first, up to 721 days
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Population consisted of all patients who are randomized and was based upon the randomized treatment, regardless of the treatment actually received. Patients were in the ITT analysis whether or not they received study drug. The primary and secondary efficacy analyses were presented primarily for the ITT Population.
Arm/Group Title Paclitaxel+Reparixin (Group 1) - ITT Population Paclitaxel+Placebo (Group 2)
Hide Arm/Group Description:

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.

Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

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.

Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

Overall Number of Participants Analyzed 62 61
Median (Inter-Quartile Range)
Unit of Measure: Days
166
(62 to 292)
171
(105 to 393)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paclitaxel+Reparixin (Group 1) - ITT Population, Paclitaxel+Placebo (Group 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.589
Comments p-value based on a log-rank test stratified by randomized sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.71 to 1.81
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description

OS was defined as the time from randomization until death due to any cause. For patients who did not die, time of death was censored at the date of last contact.

Patients must have completed at least one course of treatment and performed at least one disease assessment to be considered evaluable for response.

Time Frame Baseline until death due to any cause, up to 985 days
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Population consisted of all patients who are randomized and was based upon the randomized treatment, regardless of the treatment actually received. Patients were in the ITT analysis whether or not they received study drug. The primary and secondary efficacy analyses were presented primarily for the ITT Population.
Arm/Group Title Paclitaxel+Reparixin (Group 1) - ITT Population Paclitaxel+Placebo (Group 2)
Hide Arm/Group Description:

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.

Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

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.

Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

Overall Number of Participants Analyzed 62 61
Median (Inter-Quartile Range)
Unit of Measure: Days
483
(272 to 812)
531
(334 to 787)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paclitaxel+Reparixin (Group 1) - ITT Population, Paclitaxel+Placebo (Group 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.897
Comments p-value based on a log-rank test stratified by randomized sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.64 to 1.65
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description

The ORR was defined as the percentage of patients achieving CR or PR in the Evaluable Population. The response rate was calculated from the independently reviewed assessment best response. In case of PR or CR, only confirmed cases were considered to be responses.

Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients with unknown or missing response, including response of "not all evaluated" or "unable to determine", were treated as non-responders; i.e., they were included in the denominator when calculating the percentages.

Patients must have completed at least one course of treatment and performed at least one disease assessment to be considered evaluable for response.

Time Frame Baseline up to every 8 weeks until documented disease progression, up to 56 months
Hide Outcome Measure Data
Hide Analysis Population Description
Responsible-evaluable population: this population consisted of all patients who had completed at least one cycle of treatment and had a baseline assessment and have undergone at least one post-baseline disease assessment.
Arm/Group Title Paclitaxel+Reparixin (Group 1) - ITT Population Paclitaxel+Placebo (Group 2)
Hide Arm/Group Description:

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.

Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

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.

Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

Overall Number of Participants Analyzed 57 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
28.1
(17.0 to 41.5)
25.9
(15.0 to 39.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paclitaxel+Reparixin (Group 1) - ITT Population, Paclitaxel+Placebo (Group 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.667
Comments P-value is based on Zelen's test for homogeneity of the odds ratios.
Method Zelen's test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.262
Confidence Interval (2-Sided) 95%
0.4909 to 3.963
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Median Progression-free Survival (mPFS)
Hide Description

PFS was defined as the time from randomization to first documentation of disease progression, according to RECIST criteria version 1.1, as assessed by Independent Radiology Review, or to death due to any cause, whichever occurred first. For each treatment group, the Kaplan-Meier estimates for the median PFS time, the first and third quartiles were presented, along with approximate 95% confidence intervals if there were a sufficient number of progressions or deaths.

Patients must have completed at least one course of treatment and performed at least one disease assessment to be considered evaluable for response.

Time Frame At screening and every 8 weeks, up to 721 days
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Population consisted of all patients who are randomized and was based upon the randomized treatment, regardless of the treatment actually received. Patients were in the ITT analysis whether or not they received study drug. The primary and secondary efficacy analyses were presented primarily for the ITT Population.
Arm/Group Title Paclitaxel+Reparixin (Group 1) - ITT Population Paclitaxel+Placebo (Group 2)
Hide Arm/Group Description:

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.

Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

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.

Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

Overall Number of Participants Analyzed 62 61
Median (95% Confidence Interval)
Unit of Measure: Days
166
(109 to 218)
171
(117 to 226)
5.Secondary Outcome
Title Duration of Overall Response (DOR)
Hide Description

Duration of overall response (DOR) in days for the investigator assessments is measured from the time response criteria are first met for CR or PR (whichever is first recorded on the "Disease Response" page on the CRF) until either death or the first date that recurrent or PD is objectively documented (on the "Disease Response" p. on the CRF or the Follow-Up Disease Evaluation page indicates disease progression and there is supporting information in the Disease Status pages) per RECIST version 1.1. Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. If a patient is lost to follow-up with no documentation of PD, DOR was censored at the last evaluable tumor assessment. DOR was calculated only for responding patients (PR or CR) as recorded on the CRF page "Disease Response" based upon the RECIST version 1.1.

Duration of overall response wa

Time Frame Baseline up to every 8 weeks until documented disease progression, up to 557 days
Hide Outcome Measure Data
Hide Analysis Population Description
The Response-Evaluable Population consisted of all patients who had completed at least one cycle of treatment and had a baseline assessment and have undergone at least one post-baseline disease assessment.
Arm/Group Title Group 1 - Response Evaluable Population Group 2 - Response-Evaluable Population
Hide Arm/Group Description:

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.

Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

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.

Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

Overall Number of Participants Analyzed 57 54
Median (Inter-Quartile Range)
Unit of Measure: Days
293.0
(119.0 to 505.0)
172.0
(115.0 to 443.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 - Response Evaluable Population, Group 2 - Response-Evaluable Population
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.519
Comments For the All Patients group, p-value was based on a log-rank test stratified by actual sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Best Overall Response (BOR)
Hide Description BOR is defined as the best response among all overall responses (in the order complete response [CR], partial response [PR], stable disease [SD], and progressive disease [PD]) recorded as an independent review response from the start of reparixin or placebo until disease progression/recurrence or end of treatment, or death, whichever comes first. The status of BOR of PR or CR needs to be confirmed by repeat tumor assessment within no less than 4 weeks according to RECIST version 1.1. Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. If the status of CR or PR cannot be confirmed by repeat tumor assessment, the best overall response of unconfirmed CR and PR will be PR and SD, respectively. Patients must have completed at least one course of treatment and performed at least one disease assessment to be considered evaluable for response.
Time Frame From the start of treatment, every 8 weeks, up to 56 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Response-Evaluable Population consisted of all patients who had completed at least one cycle of treatment and had a baseline assessment and have undergone at least one post-baseline disease assessment.
Arm/Group Title Group 1 - Response Evaluable Population Group 2 - Response-Evaluable Population
Hide Arm/Group Description:

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.

Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

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.

Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

Overall Number of Participants Analyzed 57 54
Measure Type: Number
Unit of Measure: participants
CR 1 0
PR 15 14
SD 16 23
PD 22 14
NE 3 3
Unable to determine 0 0
Unknown/not done 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 - Response Evaluable Population, Group 2 - Response-Evaluable Population
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.667
Comments P-value was based on Zelen's test for homogeneity of the odds ratios
Method Zelen's test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.101
Confidence Interval (2-Sided) 95%
0.437 to 2.790
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Treatment-Emergent Adverse Events (TEAEs), Overall and by Grade
Hide Description Treatment-emergent adverse events (TEAEs) are those which first occur or increase in severity or relationship to study drug after the first dose of study drug and before 30 days after the last dose of study treatment, reparixin/placebo. In the case of missing or partial dates, any AE that could have started on or after first dose date was assumed to be treatment-emergent. In the case of missing or partial dates, imputed dates (see section 10.1 AE date imputation) were used.
Time Frame Throughout the study, until off-treatment visit (performed 14 to 28 days following the last dose of study drug), up to 985 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: this population consisted of all patients who had taken at least one dose of the study treatment and was based upon the treatment they actually received.
Arm/Group Title Paclitaxel+Reparixin (Group 1) - Safety Population Paclitaxel+Placebo (Group 2) - Safety Population
Hide Arm/Group Description:

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.

Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

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.

Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

Overall Number of Participants Analyzed 61 60
Measure Type: Number
Unit of Measure: number of events
Overall 865 730
Grade 1 (mild) 563 478
Grade 2 (moderate) 230 194
Grade 3 (severe) 67 50
Grade 4 (Life-threatening or disabling) 2 4
Grade 5 (death) 3 4
8.Secondary Outcome
Title Serious AEs and Fatal AEs
Hide Description

A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose

  1. - results in death, (fatal)
  2. - is life-threatening
  3. - requires inpatient hospitalization or causes prolongation of existing hospitalization
  4. - results in persistent or significant disability/incapacity,
  5. - may have caused a congenital anomaly/birth defect, or
  6. - requires intervention to prevent permanent impairment or damage.
Time Frame Throughout the study, until off-treatment visit (performed 14 to 28 days following the last dose of study drug), up to 985 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: this population consisted of all patients who had taken at least one dose of the study treatment and was based upon the treatment they actually received.
Arm/Group Title Paclitaxel+Reparixin (Group 1) - Safety Population Paclitaxel+Placebo (Group 2) - Safety Population
Hide Arm/Group Description:

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.

Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

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.

Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

Overall Number of Participants Analyzed 61 60
Measure Type: Number
Unit of Measure: number of events
serious AE 31 25
Fatal AE 3 4
Time Frame Throughout the study, until off-treatment visit (performed 14 to 28 days following the last dose of study drug), up to 985 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paclitaxel+Reparixin (Group 1) - Safety Population Paclitaxel+Placebo (Group 2) - Safety Population
Hide Arm/Group Description

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.

Duration of Treatment: 28-day cycles of combination therapy reparixin oral tablets + paclitaxel intravenous weekly three weeks on and one week off until disease progression according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

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.

Duration of Treatment: 28-day cycles of combination therapy placebo oral tablets + paclitaxel intravenous weekly three weeks on and one week off until PD according to RECIST criteria version 1.1, withdrawal of consent or unacceptable toxicity, whichever occurred first.

All-Cause Mortality
Paclitaxel+Reparixin (Group 1) - Safety Population Paclitaxel+Placebo (Group 2) - Safety Population
Affected / at Risk (%) Affected / at Risk (%)
Total   42/61 (68.85%)      35/60 (58.33%)    
Hide Serious Adverse Events
Paclitaxel+Reparixin (Group 1) - Safety Population Paclitaxel+Placebo (Group 2) - Safety Population
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/61 (21.31%)      12/60 (20.00%)    
Blood and lymphatic system disorders     
Anaemia  1  1/61 (1.64%)  1 1/60 (1.67%)  1
Febrile neutropenia  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Cardiac disorders     
Cardiac failure congestive  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Pericardial effusion  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Gastrointestinal disorders     
Constipation  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Intestinal perforation  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Stomatitis  1  0/61 (0.00%)  0 1/60 (1.67%)  1
General disorders     
Non-cardiac chest pain  1  2/61 (3.28%)  2 0/60 (0.00%)  0
Condition aggravated  1  1/61 (1.64%)  1 0/60 (0.00%)  0
General physical health deterioration  1  1/61 (1.64%)  1 1/60 (1.67%)  1
Pyrexia  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Asthenia  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Disease progression  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Infections and infestations     
Erysipelas  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Lung infection  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Peritonitis  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Pneumonia influenzal  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Pneumonia  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Sepsis  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Fall  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Investigations     
Alanine aminotransferase increased  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Aspartate aminotransferase increased  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Gamma-glutamyltransferase increased  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Metabolism and nutrition disorders     
Gout  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Hyponatraemia  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Hyperglycaemia  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Presyncope  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant pleural effusion  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Metastases to central nervous system  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Nervous system disorders     
Myelopathy  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Headache  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  2/61 (3.28%)  2 0/60 (0.00%)  0
Pleural effusion  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Haemothorax  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Pulmonary embolism  1  0/61 (0.00%)  0 1/60 (1.67%)  1
Respiratory failure  1  0/61 (0.00%)  0 3/60 (5.00%)  3
Vascular disorders     
Deep vein thrombosis  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Embolism  1  1/61 (1.64%)  1 0/60 (0.00%)  0
Thrombosis  1  0/61 (0.00%)  0 1/60 (1.67%)  1
1
Term from vocabulary, MedDRA 20
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Paclitaxel+Reparixin (Group 1) - Safety Population Paclitaxel+Placebo (Group 2) - Safety Population
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/61 (34.43%)      21/60 (35.00%)    
Skin and subcutaneous tissue disorders     
Alopecia  1  21/61 (34.43%)  26 21/60 (35.00%)  21
1
Term from vocabulary, MedDRA 20
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Pier Adelchi Ruffini, MD
Organization: Dompé Farmaceutici SpA
Phone: +39 02 583831
EMail: info@dompe.it
Layout table for additonal information
Responsible Party: Dompé Farmaceutici S.p.A
ClinicalTrials.gov Identifier: NCT02370238    
Other Study ID Numbers: REP0114
2014-004796-23 ( EudraCT Number )
First Submitted: February 11, 2015
First Posted: February 24, 2015
Results First Submitted: April 6, 2021
Results First Posted: June 2, 2021
Last Update Posted: June 2, 2021