Phase 1 study of CS-7017 in combination with FOLFIRI
Ontology highlight
ABSTRACT: Intervention name : CS-7017
INN of the intervention : efatutazone
Dosage And administration of the intervention : CS-7017(0.25-0.50 mg) administered orally twice a day
Control intervention name : null
Primary outcome(s): Safety and Pharmacokinetics
-To evaluate the safety profile according to CTCAE
-To evaluate the pharmacokinetics according to the protocol
Study Design: Open Label Phase 1 Study
DISEASE(S): Metastatic Crc Who Failed First-line Therapy
Project description:Interventions: investigational material(s)
Generic name etc : CS-7017
INN of investigational material : efatutazone
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : CS-7017(0.25-0.50 mg) administered orally twice a day
Primary outcome(s): Safety and Pharmacokinetics
-To evaluate the safety profile according to CTCAE
-To evaluate the pharmacokinetics according to the protocol
Study Design: Open Label Phase 1 Study
Project description:Intervention name : YHI-1003
INN of the intervention : Perifosine
Dosage And administration of the intervention : oral
Control intervention name : null
Primary outcome(s): safety
CTCAE v4.0
Study Design: open-label, multicenter trial
Project description:The ditelocentric addition line CS-7EL of the spring wheat (Triticum aestivum) cultivar Chinese Spring (CS) contains the long arm of the chromosome 7E from Thinopyrum elongatum (CS-7EL), which confers high resistance to fusarium head blight. It is of great interest to breeders to integrate the resistance locus (loci) from Th. elongatum into commercial wheat varieties. The objectives of this study were to identify candidate genes expressed from the 7EL chromosome of CS-7EL, to develop 7EL-specific molecular markers, and to validate their usefulness to characterize recombination between one of the group 7 chromosomes of wheat and Th. elongatum. High-throughput sequencing of Fusarium graminearum-infected and control CS and CS-7EL cDNA libraries was performed using RNA-Seq. A stepwise bioinformatics strategy was applied to assemble the sequences obtained from RNA-Seq and to create a conservative list of candidate genes expressed from the foreign chromosome 7EL. PCR primer pairs were designed and tested for 135 candidate genes. A total of 48 expressed molecular markers specific for the chromosome 7EL were successfully developed. Screening of progenies from two BC1F2 families from the cross CS-7E(7D)×2*CSph1b showed that these markers are useful to characterize recombination events between the chromosomes 7D from wheat and 7E from Th. elongatum.
Project description:Cockayne syndrome B (CSB) protein is a member of the SWI/SNF family and has DNA-dependent ATPase and ATP-dependent chromatin remodeling activities. The CSB protein is missing or altered in CS-B cells. CS-B cells are hypersensitive to UV light and defective in transcription-coupled DNA repair (TCR). TCR efficiently removes a variety of lesions from the transcribed strand of active genes. It has been shown that lesions specifically in the transcribed strand of active genes trigger the induction of apoptosis following UV irradiation. Several DNA damage signaling cascades, including the ATR/Chk1, p38 kinase, p53, and jun N-terminal kinase pathways are activated following UV irradiation. However, the role of TCR in cellular global transcriptional responses to UV irradiation remains to be elucidated. Using oligonucleotide microarray technology, we analyzed the time course of responses of CS-B cells (CS-B) and CS-B cells complemented with wild-type CSB cDNA (CS-B wt). Keywords: UV response, time course, disease state analysis
Project description:This was a Phase 1, open-label, single-center study of CS-1008, an immunoglobulin G subclass 1 (IgG1) humanized monoclonal antibody, in subjects with advanced colorectal carcinoma who had received ≥ 1 prior chemotherapy regimen for metastatic disease. Primary study objectives were to determine the influence of the CS-1008 dose on the biodistribution, pharmacokinetics (PK) and tumor uptake of radiolabeled CS-1008 following a single infusion and following continuous sequential doses of CS-1008. Secondary objectives were to evaluate changes in tumor metabolism, antitumor response, and changes in serum apoptosis biomarkers and tumor response markers following treatment with CS-1008.