International, Multicenter, Open-label, Treatment-extension Study for Subjects Who Completed a Phase 1 or Phase 2 Parental Study to Continue Receiving Treatment With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen
Description
Brief Summary
Primary Objective:
The purpose of this study was to determine the long term safety and tolerability of SAR245408
and SAR245409 as a monotherapy or as part of a combination regimen in participants who were
benefiting from treatment.
Detailed Description
The duration of the study for an individual participant included:
1. Baseline assessments: within 7 days prior to the first dose of investigational medicinal
product (IMP).
2. Study treatment period(s):
Participants started study treatment at the beginning of the initiation or extension
periods based on the length of prior therapy with SAR245408 or SAR245409
- if <2 cycles, started with initiation period; Participant must have had completed
all the visits in the initiation period before moving to the extension period.
- if >=2 cycles, started with extension period; duration of extension period was
unlimited.
- Participants who took a SAR245408 or SAR245409 daily dose higher than their
established dose of SAR245408 or SAR245409, respectively, in the parental study
entered the study on Day 1 of the initiation period.
- Participants who had dose interrupted in the parental study but fulfilled parental
protocol criteria to restart IMP treatment entered the treatment-extension study on
Day 1 of the initiation period.
- Participants who fulfilled the parental study criteria for IMP treatment
continuation but had ongoing Grade 2 adverse events (AEs) entered the
treatment-extension study on Day 1 of the initiation period.
Participants continued to receive study treatment until disease progression,
unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408
or SAR245409 were available to them outside of the clinical trial.
3. Follow-up assessments: 23 to 37 days after the last dose of IMP.
Phase
Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.Inclusion and Exclusion Criteria
- Inclusion criteria :
- Males or females enrolled in Phase 1 or Phase 2 studies of SAR245408 or SAR245409 as monotherapy or in combination with other regimens who had completed data collection for the primary endpoint(s) of the parental study or who were being treated beyond the parental study cut-off and meet all the criteria to continue to be treated per the parental protocol.
- All sexually active participants (male and female) must agreed to continue to use accepted methods of barrier contraception (i.e., condoms) during the course of the study and for 3 months after discontinuation of study treatment. For women of childbearing potential and for men who could father a child, a second method of contraception in addition to a barrier method is recommended. Hormonal contraception should be avoided in participants taking SAR245408 due to possible drug-drug interaction.
- Female participants of childbearing potential must had a negative pregnancy test at baseline. Females of childbearing potential were defined as sexually mature women without prior hysterectomy or who had any evidence of menses in the past 12 months. However, women who had been amenorrheic for 12 or more months were still considered to be of childbearing potential if the amenorrhea was possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression. Exclusion criteria:
- Ongoing Grade
- Ongoing Serious Adverse Event (SAE). E 04. Participants with ongoing dose interruption for any reason unless the participant fulfilled the criteria in the parental protocol for restarting IMP. In such case participant started the treatment-extension study on Day 1 of the initiation period.
- The participant had any of the following laboratory values ≥ Common Terminology of Adverse Events (CTCAE) Grade 3 - Absolute neutrophil count (ANC), - Platelet count, - Hemoglobin, - Bilirubin, - Serum creatinine or calculated creatinine clearance, - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST), - Fasting plasma glucose (FPG), - Prothrombin time/international normalized ratio (PT/INR) and activated partial thromboplastin time (aPTT).
- The participant had a baseline corrected QT interval (QTc) >481 millisecond (msec) or if a participant has had a QTc interval increase of ≥ 60 msec from parental protocol baseline to an absolute value of > 470 msec.
- The participant had a known allergy or hypersensitivity to components of the study treatment formulation(s).
- The participant was pregnant or breastfeeding. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites
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California
- Investigational Site Number 840008, Los Angeles, California, 90033
- Investigational Site Number 840009, Los Angeles, California, 90024
- Investigational Site Number 840009, Los Angeles, California, 90024
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Colorado
- Investigational Site Number 840022, Denver, Colorado, 80262
- Investigational Site Number 840022, Denver, Colorado, 80262
-
Texas
- Investigational Site Number 840005, San Antonio, Texas, 78229
- Investigational Site Number 840003, Dallas, Texas, 75230
-
Missouri
- Investigational Site Number 840021, St Louis, Missouri, 63110
- Investigational Site Number 840021, St Louis, Missouri, 63110
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Tennessee
- Investigational Site Number 840007, Nashville, Tennessee, 37232
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Alabama
- Investigational Site Number 840010, Birmingham, Alabama, 35205
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