Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: PRIME
This phase Ib trial determines if samples from a patient's cancer can be tested to find combinations of drugs that provide clinical benefit for the kind of cancer the patient has. This study is also being done to understand why cancer drugs can stop working and how different cancers in different people respond to different types of therapy.
Genomics-Based Target Therapy for Children With Relapsed or Refractory Malignancy
The purpose of this study is to evaluate the efficacy and feasibility of combination chemotherapy with target agents according to the result of targeted deep sequencing in pediatric patients with relapsed/refractory solid tumor or AML.
A Dose Escalation Safety and Pharmacokinetic Study of SAR103168 Administered as a Single Agent by Intravenous Infusion, Once Daily for 5 Consecutive Days to Patients With Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes.
Primary objectives:
To determine the maximum tolerated dose (MTD) of SAR103168 and to characterize the dose limiting toxicities (DLTs) in the proposed dose regimen
To evaluate the pharmacokinetic (PK) profile of SAR103168
Secondary objectives:
To characterize the global safety profile of SAR103168
To evaluate preliminary anti-leukemia activity
To investigate the potential induction effect on CYP3A4 and persistence of this effect by using oral midazolam as a probe substrate in patients enrolled into the expanded cohort at the MTD
To determine the metabolic pathways of SAR103168 and identify the chemical structures of metabolites
To determine the potential impact of SAR103168 on the QTc interval in patients enrolled at the MTD
100 Clinical Results associated with ABL x EGFR x FGFR1 x FGFR3 x PDGFR x SRC x Tie-2 x VEGFR1 x VEGFR2
100 Translational Medicine associated with ABL x EGFR x FGFR1 x FGFR3 x PDGFR x SRC x Tie-2 x VEGFR1 x VEGFR2
0 Patents (Medical) associated with ABL x EGFR x FGFR1 x FGFR3 x PDGFR x SRC x Tie-2 x VEGFR1 x VEGFR2