Glossary

A

Antibody
A protein produced by the immune system in response to the presence of a specific antigen and that binds to the antigen. When antibodies bind to corresponding antigens, they usually set in motion a process to eliminate the antigens.

A monoclonal antibody is produced by cells created through the
fusion of an antibody-producing cell (such as a B-lymphocyte) with
an immortalized cell. This process is accomplished in a laboratory
and produces hybrid cells that express properties of both parent cells. The cells are all identical since they derive from a single cell and therefore are called “monoclonal.” These cells produce large amounts of a specific antibody that binds to a specific antigen.

Antigen
A foreign substance that, when introduced into the body, stimulates
the immune system to produce antibodies as part of the body’s
defense against infection and disease.

Apoptosis (Programmed cell death)
The body’s normal method of disposing of damaged, unwanted, or
unneeded cells. Apoptosis signifies a process in which certain signals
lead cells to self-destruct. This is one way by which the organism
protects itself against cells that have taken the first step in the transformation into cancer cells. Cancer cells, on the other hand, often carry mutations that make them resistant to this form of cell death.

B

Breast cancer
A cancerous growth in breast tissue.

C

Cell
The basic unit of which all living things are made. Cells replace themselves by dividing and forming new cells (mitosis). The processes that control the formation of new cells and the proper growth cells are disrupted in cancer.

Cell cycle
A highly regulated process of several phases through which a cell goes in order to divide and produce two daughter cells.

Chemotherapy
Treatment of cancer or other malignant diseases by the use of drugs
that interfere with the growth or reproduction of malignant cells.

First-line chemotherapy is the first application of chemotherapy for
patients who have not been treated with a chemotherapeutic regimen
previously.

Second-line chemotherapy is the application of a different kind of chemotherapy regimen for patients who already have failed one chemotherapeutic regimen.

Cytoplasm
The material that lies within the plasma membrane. It contains none
of a cell’s genetic material, because this is contained in the nucleus.
It contains fluid and the other organelles of the cells.
 

D

Data Monitoring Board (DMB)
An independent, impartial committee composed of clinical research
experts who review data while a clinical trial is in progress to ensure
that participants are not exposed to undue risk. A DMB may recommend that a trial be stopped or continued based on safety, efficacy or ethical reasons.

Double-blind study
A clinical trial design in which neither the participating individuals
nor the study staff know which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results since the expectations of the doctor and the participant about the experimental drug do not affect the outcome.

E

EMEA (European Medicines Agency)

This organization is in charge of coordinating scientific resources in
member states of the European Union with a view to evaluating and
supervising medicinal products for both human and veterinary use.

F

G

H

Hazard ratio
An estimate of relative risk. E.g., the protocol-specified hazard ratio of the SPARC trial measured the overall risk of disease progression.

I - L

Immune system
The complex system of organs, cells, and natural substances that normally protects the body from infections, diseases, and foreign substances by attacking the invaders or the abnormal cells. The immune system may also help the body fight some cancers.

Indication
A sign, symptom, or medical condition that leads to the recommendation of a treatment, test, or procedure.

Inhibitor
A chemical or biological substance that can reduce or shut off specific
biological or biochemical processes.

Intent to treat analysis
Analysis of clinical trial results that includes all data from participants
in the groups to which they were randomized, whether or not they
received treatment.

Investigational New Drug (IND)
An Investigational New Drug (IND) Application is a request for
authorization from the FDA to administer an investigational drug or
biological product to humans.

In vitro
Outside a living organism. Pertaining to a biochemical process or
reaction that takes place in a test tube or other non-living laboratory
setting, rather than in a living organism.

In vivo
Within a living organism. Pertaining to a biological or biochemical
process or reaction that takes place in a living organism, such as yeast, animals or humans.

Kinases
A specific class of enzymes (catalyst proteins) that attaches a phosphate group to another molecule. Kinases function to regulate biological processes and therefore are important targets for drugs.

Leukemia
Cancer of the blood or blood-forming tissues, such as bone marrow.
People with leukemia often have a noticeable increase in white blood
cells.

Chronic lymphocytic leukemia (CLL) is a common type of slowly progressing cancer in which too many lymphocytes are found in the
peripheral blood and bone marrow.

Log-rank test
Statistical analysis that evaluates differences between two arms in a
trial over all time points.

Lung cancer
A cancerous growth in lung tissue.

Non-small cell lung cancer (NSCLC) is a group of lung cancers that
includes squamous cell carcinoma, adenocarcinoma, and large cell
carcinoma. Approximately 80 percent of all lung cancers are nonsmall cell lung cancer.

Small cell lung cancer is a type of lung cancer in which the cells are small and round. Also called oat cell lung cancer.

Lymphoma
A cancer that begins in the cells of the immune system and collects in the lymphatic system, a network of thin vessels and nodes throughout the body whose function is to fight infection. Lymphoma involves a type of white blood cells called lymphocytes.

B-cell lymphoma is a type of cancer associated with the uncontrollable growth of B-cells, a specific kind of immune cell.

Hodgkin’s lymphoma is a cancer in the lymphatic system that causes
the cells in the lymphatic system to abnormally reproduce, eventually
making the body less able to fight infection.

Hodgkin’s lymphoma is a cancer in the lymphatic system that causes
the cells in the lymphatic system to abnormally reproduce, eventually
making the body less able to fight infection.

Non-Hodgkin’s lymphoma – the most common form of lymphoma – is a cancer in the lymphatic system that causes the cells in the lymphatic system to abnormally reproduce, eventually causing tumors to grow. Non-Hodgkin’s lymphoma cells can also spread to other organs.

M

Marketing Authorization Application (MAA)
Request for authorization from the EMEA to market a new drug
product.

Mechanism-of-action
The molecular process by which a substance produces a reaction or a
series of reactions that lead to a physiological effect in the body.

Median
In statistics the median is the middle of a distribution: half the scores are above the median and half are below. The median is less sensitive to extreme scores than the mean.

Metastasis
The spread of cancer from its original site to another part of the
body.

Multiple myeloma
A cancer that affects blood plasma cells. The disease causes the
growth of tumors in many bones, which can lead to bone pain and
fractures. In addition, the disease often causes kidney problems and
lowered resistance to infection.

Myelosuppression
Depression of bone marrow functions, such as lowered platelet count
or lowered white blood cell count.

N

New Drug Application (NDA)
Request for authorization from the FDA to market a new drug
product.

Nucleus
A vital body in the central portion of a cell which contains the genetic
code; an essential agent in the regulation of growth, reproduction,
and the transmission of cell characteristics.

O

Oncology
The study of cancer.

Open label study
A clinical study in which doctors and participants know what drug
is being administered.

Orphan drug designation
Designation by the EMEA, that is designed to promote the development of drugs to treat rare life-threatening or very serious conditions that affect no more than five in every 10,000 people in the European Union (EU). The designation provides EU market exclusivity for up to ten years in the given indication. A similar program exists in the U.S. through the FDA.

P

Phase 1 (of clinical development)
Part of clinical development in which an investigational new drug is
normally tested on healthy human volunteers in order to evaluate its
potential toxicity, pharmacokinetic properties and suitable dosage.
In the case of anticancer drugs, actual volunteer cancer patients are
treated in Phase 1.

Phase 2 (of clinical development)
Part of clinical development in which the short-term efficacy, potential
side effects and optimal dose of an investigational new drug
are tested on a small number of patients suffering from the disease
targeted by the drug. In the case of anticancer drugs, patients with
a specific cancer type are selected for treatment.

Phase 3 (of clinical development)
Part of clinical development in which an investigational new drug is
tested in a large number of patients (often hundreds or thousands)
to evaluate its safety and efficacy in order to evaluate the risk-benefit of the potential new therapy.

Placebo
An inactive pill, liquid or powder that has no treatment value.

Plasma Membrane
The outer lining of the cell that is responsible for regulation of the
cell’s internal environment.

Principal Investigator
A medical researcher responsible of carrying out a clinical trial
protocol.

Prostate
A male sex gland that produces a viscid secretion that forms part of
the seminal fluid.

P-value
The probability (from zero to one) that the results observed in a study could have occured by chance.

Protein
A large molecule composed of one or more chains of amino acids in
a specific order. Proteins are required for the structure, function and
regulation of the body’s cells, tissues and organs, and each protein
has unique functions. Examples include enzymes and antibodies.

Q - R

Radiation therapy
Treatment with high-energy rays (such as x-rays) to kill or shrink cancer cells. The radiation may come from outside of the body (external radiation) or from radioactive materials placed directly in the tumor (internal or implant radiation). Radiation therapy may be used to reduce the size of a cancer before surgery, to destroy any remaining cancer cells after surgery, or, in some cases, as the main treatment. Radiation therapie is useful in the treatment of localized cancers.

Randomized trial
A study in which participants are randomly (i.e., by chance) assigned
to one of two or more treatment arms of a clinical trial.

Refractory disease
Diseases that have not responded or no longer respond to a particular treatment.

Relapsed disease
The return of signs and symptoms of diseases after a period of improvement.

S

Small molecule
A substance of relatively small size, e.g., a drug, as opposed to large molecules such as proteins and antibodies. 

Solid tumor
An abnormal mass of tissue that usually does not contain liquid
areas. Different types of solid tumors are named for the type of cells
that form them.

T

Taxane
A class of drug that inhibits cell growth by stopping cell division.
Taxanes are used as treatments for cancer. Also called antimitotic or
antimicrotubule agents or mitotic inhibitors. The marketed drugs
Taxotere and Taxol are taxanes. 

U - W

X - Z