- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01392924
Safety and Pharmacokinetics of SAR245408 Daily Oral in Patients With Solid Tumors
An Open Label, Dose Escalation Study Evaluating the Safety and Pharmacokinetics of SAR245408 Administered Orally Daily in Patients With Solid Tumors
Primary Objective:
- To confirm safety and tolerability of global recommended phase three dose (RPTD) of SAR245408 tablets when administered on continuous once daily dosing (CDD) in patients with solid tumors.
Secondary Objectives:
- To evaluate the plasma pharmacokinetics (PK) of daily oral administration of SAR245408 in CDD treatment schedule in patients with solid tumors.
- To gather preliminary efficacy data after repeated administration of SAR245408 in patients with solid tumors.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Kobe-Shi, Japan
- Investigational Site Number 392002
-
Nagoya-Shi, Japan
- Investigational Site Number 392001
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Histologically or cytologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival.
- Before any study-specific procedure, the appropriate Institutional Review Board (IRB) approved written informed consent must be obtained. Second informed consent must be obtained before the patient starts the Treatment Extension Period (Cycle 2 and after).
Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Exclusion criteria:
- < 20 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status > 2.
- Incapable of understanding or complying with the protocol or has not signed the informed consent document.
- Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
- Inadequate organ or bone marrow function.
- Prothrombin time (PT)/International Normalized Ratio (INR) and/or partial thromboplastin time (PTT) test results at screening that are above 1.3 × the laboratory upper limit of normal (ULN).
- Baseline corrected QT interval (QTc) > 460 ms.
- Sexually active (males and females) who do not agree to use medically acceptable methods of contraception during the course of the study and for 3 months following discontinuation of study drug. Female patients of childbearing potential must have a negative pregnancy test at screening.
- Pregnant or breastfeeding.
- Has not tolerated previous treatment with other phosphatidylinositol 3-kinase (PI3K) inhibitor, or has been treated with SAR245408.
- Not recovered from all previous therapies (i.e. radiation, surgery, or medication)
- Currently receiving anticoagulation with therapeutic doses of warfarin (low-dose warfarin ≤ 1mg/day is permitted).
- Primary brain tumor or brain metastasis are considered eligible if the patient has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more weeks.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including cytomegalovirus, Epstein-Barr virus, toxoplasmosis, and hepatitis B and C), symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Known to be positive for the human immunodeficiency virus (HIV)
- Psychiatric illness/social situation(s) that would limit compliance with study requirements.
- Allergy or hypersensitivity to components of the SAR245408 formulation.
- Withdraws consent during the screening (starting from signed informed consent form (ICF))
- Patient who is judged by the investigator as not suitable for participating in the study
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SAR245408
single cohort: SAR245408 administered once daily
|
Pharmaceutical form: tablet Route of administration: oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose limiting toxicity in cycle 1
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of treatment emergent adverse events
Time Frame: 28 days after the last dosing
|
28 days after the last dosing
|
|
Number of serious adverse events
Time Frame: 28 days after the last dosing
|
28 days after the last dosing
|
|
Number of abnormality of laboratory test as graded by National Cancer Institute-Common Toxicity Criteria
Time Frame: 28 days after the last dosing
|
28 days after the last dosing
|
|
Pharmacokinetics (Cmax) of SAR245408
Time Frame: an expected average of 3 months
|
Cycles 1 and 2, and every 4th cycle after Cycle 4
|
an expected average of 3 months
|
Pharmacokinetics (tmax) of SAR245408
Time Frame: an expected average of 3 months
|
Cycles 1 and 2, and every 4th cycle after Cycle 4
|
an expected average of 3 months
|
Pharmacokinetics (AUC) of SAR245408
Time Frame: an expected average of 3 months
|
Cycles 1 and 2, and every 4th cycle after Cycle 4
|
an expected average of 3 months
|
Pharmacokinetics (accumulation ratio) of SAR245408
Time Frame: an expected average of 3 months
|
Cycles 1 and 2, and every 4th cycle after Cycle 4
|
an expected average of 3 months
|
Pharmacokinetics (Ctrough) of SAR245408
Time Frame: an expected average of 3 months
|
Cycles 1 and 2, and every 4th cycle after Cycle 4
|
an expected average of 3 months
|
Objective tumor response as defined by RECIST (response evaluation criteria in solid tumors)
Time Frame: At 8 weeks and every 2 months thereafter
|
At 8 weeks and every 2 months thereafter
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TED11883
- U1111-1118-9727 (Other Identifier: UTN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neoplasm Malignant
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedMetastatic Malignant Neoplasm | Unresectable Malignant Neoplasm | Advanced Malignant NeoplasmUnited States
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingRefractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)Active, not recruitingRefractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States, Canada
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMalignant Neoplasm | Metastatic Malignant Neoplasm | Advanced Malignant Neoplasm | Recurrent Malignant Neoplasm | Locally Advanced Malignant NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Malignant Neoplasm | Advanced Malignant Neoplasm | Recurrent Malignant Neoplasm | Refractory Malignant Neoplasm | Locally Advanced Malignant NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Malignant Neoplasm in the Liver | Metastatic Malignant Neoplasm in the LungUnited States
-
National Cancer Institute (NCI)RecruitingAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
Clinical Trials on SAR245408
-
SanofiCompletedNeoplasm MalignantBelgium
-
SanofiCompletedEndometrial Neoplasms | Endometrial CancerUnited States, Belgium
-
SanofiCompletedLymphoma | CancerUnited States, Spain
-
SanofiCompletedSolid TumorsUnited States
-
SanofiCompletedGlioblastoma | Astrocytoma, Grade IVUnited States
-
SanofiCompletedNeoplasm MalignantSpain, Belgium, United States, France
-
SanofiMerrimack PharmaceuticalsCompletedSolid Tumor CancersUnited States
-
SanofiCompletedCancer | Non-small Cell Lung CancerUnited States
-
SanofiCompletedCancer | Non-Small Cell Lung Cancer | Endometrial Carcinoma | Ovarian CarcinomaUnited States
-
SanofiCompletedBreast Cancer | Breast NeoplasmsUnited States, Spain