National Cancer Institute - NCI Division of Cancer Treatment and ...

Combining Targeted Therapies
and the Critical Molecular
Pathways Project
A high priority for CTEP has been combining
molecularly targeted agents to achieve
optimal treatment effects. To that end,
CTEP has initiated a proof-of-principle
project called Critical Molecular Pathways
to define a series of clinical trials to evaluate
the concept of enhanced activity with
rational molecular combinations. CTEP has
also initiated other combination trials of
targeted agents.
CTEP staff are seeing proof of principle
in the remarkable antitumor activity of
novel agents in properly selected patients
whose tumors express or are driven by the
relevant molecular targets. Researchers
have entered a period of great promise in
therapeutics development as a result of
advances in understanding the molecular
biology of the cancer cell, cell signaling
pathways, and abnormal processes associated
with the malignant phenotype.
Intellectual Property Rights
CTEP also has developed standard clauses
concerning intellectual property, which
will allow drugs from two different companies
to be combined in a clinical trial in
a way that will preserve the interests of
each company while allowing this critical
research to move forward. Intellectual
property and liability concerns can slow
progress in developing trials with agents
from more than one company, either in
trials with multiple single agent arms or
those testing combination regimens.
CTEP has played an important role in
M A J O R O N G O I N G I N I T I A T I V E S
facilitating collaborations within the
private sector without the need for
additional bargaining between the
parties. CTEP developed standard language
now used in all agreements with
industry concerning how data are to be
shared and how companies may benefit
from any invention that may arise using
drug combinations.
Both the scientific and regulatory components
of CTEP have worked aggressively
to move combination therapies forward.
Clinical trials are being conducted in
several tumor types, including renal cell
carcinoma, melanoma, glioblastoma, and
cancers of the lung, ovary, pancreas, head
and neck, colon, and breast.
Clinical Trials Cooperative
Group Program
http://ctep.cancer.gov/resources/
coop2.html
CTEP supports 11 organizations conducting
cancer treatment trials through the
Clinical Trials Cooperative Group Program.
Emphasis is placed on the development
and conduct of large, multicenter, randomized
phase III studies. Although the
program’s mission encompasses a wide
variety of investigational efforts, the cooperative
groups do not replace funding
mechanisms for more narrowly focused
research project grants, such as RO1 and
PO1 grants or U01 and U19 cooperative
agreements.
Cooperative groups consist of networks
of researchers who develop and conduct
cancer treatment clinical trials.
C A N C E R T H E R A P Y E V A L U A T I O N P R O G R A M ■ 67