Track topics on Twitter Track topics that are important to you
The goal of this clinical research study is to find the highest safe dose of a liposomal Growth Factor Receptor Bound Protein-2 antisense oligodeoxynucleotide (L-Grb2 AS) that can be given as treatment for patients with Philadelphia Chromosome positive CML, AML, CLL and MDS. The trade name of this drug is BP-100-1.01. The response of the leukemia to this treatment will also be studied. In addition, the time needed for the body to process this drug will be evaluated.
The Philadelphia Chromosome is an unusual genetic trait found in 90-95% of patients with CML. The protein created by this unusual trait causes normal cells within the body to become cancer cells, and then causes these cells to grow and divide at a rapid rate. Researchers think that the protein Growth Factor Receptor Bound Protein-2 (Grb-2) is necessary to the growth of these cancerous cells. The drug under study may be able to prevent the cells from making this protein. Researchers hope that without this protein, the leukemia cells will die.
Between 18 and 30 patients are expected to be enrolled on this study. Between 3 and 6 patients will be treated at each dose level. Each new group will be treated at a dose higher than the previous group. If the highest safe dose of the study drug is not found after the completion of this study, additional doses or another study may be considered.
The study drug is an antisense molecule complementary to the mRNA (messenger RNA) code for the cell's expression of the protein Grb-2. The study drug is incorporated into lipid (fat) particles known as liposomes. This incorporation process is part of the manufacturing procedure and is done before the drug is administered. The liposomes (which carry the study drug) will then be injected into a vein twice a week for at least 28 days.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and Pharmacokinetics of L-Grb-2 in Treating CML, AML, CLL and MDS
BP-100-1.01 (Liposomal Grb-2)
M. D. Anderson Cancer Center
Bio-Path Holdings, Inc.
Published on BioPortfolio: 2014-08-27T03:12:22-0400
The purpose of this study is to determine whether there is any difference of the pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in Chinese cance...
RATIONALE: Liposomal amphotericin B may be effective in controlling fever and granulocytopenia. It is not yet known which regimen of liposomal amphotericin B is more effective in treating ...
RATIONALE: Drugs like liposomal amphotericin B may be able to relieve fungal infection which can be a side effect of chemotherapy. Colony-stimulating factors such as sargramostim may incre...
RATIONALE: Caspofungin acetate or amphotericin B liposomal may be effective in preventing or controlling fever and neutropenia caused by chemotherapy, bone marrow transplantation, or perip...
RATIONALE: Drugs used in chemotherapy, such as liposomal daunorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividi...
BACKGROUND AND OBJECTIVE: Verinurad (RDEA3170) is a high-affinity, selective URAT1 transporter inhibitor in development for treating gout and asymptomatic hyperuricemia. This Phase I, single-dose stu...
Roxadustat is an orally active hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia in chronic kidney disease. This study investigated the effect of multiple daily oral do...
Amphotericin B (AMB) is a polyene macrolide antibiotic used for treating invasive fungal infections. Liposomal AMB (L-AMB) is a lipid dosage form which reduces the side effects and toxicity of the dru...
Recent approaches in treating pancreatic adenocarcinoma, an aggressive disease with limited survival, include the use of liposomal irinotecan as an option when first-line therapy has failed. Liposomal...
This drug utilization evaluation aims to review current evidence on safety and efficacy of using liposomal amphotericin B (LAMB) in newborns with candidiasis, and compare it to the conventional prepar...
Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.
Physicians who specialize in treating disorders of the RESPIRATORY SYSTEM, especially diagnosing and treating diseases and defects of the lungs and bronchial tree.
Activities involved in ensuring the safety of FOOD including avoidance of bacterial and other contamination.
Drugs used by veterinarians in the treatment of animal diseases. The veterinarian's pharmacological armamentarium is the counterpart of drugs treating human diseases, with dosage and administration adjusted to the size, weight, disease, and idiosyncrasies of the species. In the United States most drugs are subject to federal regulations with special reference to the safety of drugs and residues in edible animal products.
An office in the Department of Labor responsible for developing and establishing occupational safety and health standards.
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
Most human diseases are caused by production of abnormal proteins or malfunctioning proteins. Antisense therapy involves inhibiting production of these proteins. When a gene is known to cause a specific disease and the genetic sequence ...
Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied...