Articles Tagged ‘lapatinib’

Imaging Agent Development and Early Phase Clinical Trials

 PET scans of  lymph nodes with lymphoma in the groin and armpit (red areas).

NCI’s Cancer Imaging Program (CIP) is responsible for oversight and funding of oncology imaging research, such as the application of MRI (magnetic resonance imaging) and PET (positron emission tomography) in clinical trials. However, the larger goal of CIP is the development of new imaging techniques and their application to the development of new therapies for the cancer patient.
In phase 0 trials (for imaging agents) the goal is the development of assays that are verified in preclinical models that can be applied to first in-human studies to evaluate relevant biomarkers related to the target of interest. These studies, as would be expected, precede the established phase I through III trials that are required to establish safety and efficacy. These first in human studies are performed on a very small number of eligible trial participants. One of the underlying rationales for phase 0 studies of imaging agents is the intrinsic shortcomings of some animal models, specifically, the transferability of animal model data to humans.

Cooperative Groups Help Advance Cancer Research

Two Drugs and One Target: Women with HER2+ Breast Cancer

The NCI supports an average of over 1,300 clinical trials a year in the areas of prevention, screening, diagnostics, treatment, quality of life, supportive care, and genetics. Conducting clinical trials across multiple institutions in numerous locations requires a great deal of coordination to insure quality and consistency throughout all aspects of the trial, triggering the need for standing infrastructure with consistent policies. The NCI has supported the Clinical Trials Cooperative Group Program for over 50 years to fulfill this function.

Two Drugs and One Target: Women with HER2+ Breast Cancer

Two Drugs and One Target: Women with HER2+ Breast Cancer

Scientists have uncovered molecular and genetic approaches to identify specific genes, proteins, and molecular pathways that are important for cancer development, growth, and survival. Understanding these biological mechanisms and how they relate to cancer has been a key factor in the development and delivery of new biologic cancer therapies, especially for breast cancer, which is the most frequently diagnosed form of cancer in women worldwide.