Audio and slides for this presentation are available on YouTube: http://youtu.be/NzJ_fvSxwGk
Sara Tolaney, MD, MPH, a breast oncologist with the Susan F. Smith Center for Women's Cancers at Dana-Farber Cancer Institute, gives an overview of phase I clinical trials and some of the new drugs being tested to treat breast cancer. This talk was originally given at the Metastatic Breast Cancer Forum at Dana-Farber on Oct. 5, 2013.
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What Is a Phase I Clinical Trial?
1. Phase I Clinical Trials
Sara Tolaney, MD, MPH
Breast oncologist
Susan F. Smith Center for Women’s Cancers at
Dana-Farber Cancer Institute
October 5, 2013
2. What are clinical trials?
• Research studies that are designed to answer
questions about new ways to treat cancer
3. What are the different types of clinical trials?
Phase
Purpose
Phase I
Determine dose
Determine side-effects
(Number of people: 15-20)
Phase 2
Determine efficacy
(Number of people: <100)
Phase 3
Compare the new treatment to a
standard treatment
Number of people: 100-1000s)
4. Road To FDA Approval
Preclinical
Phase 1
Phase 2
Phase 3
FDA
Approval
5. Goals of Phase 1 Clinical Trials
• How much of a new drug can be given safely
• How often the drug needs to be given
• What are the side effects of the new drug
6. Types of Phase 1 Trials
• Disease specific phase 1 studies
• All-comer phase 1 trials open to any solid
tumor
• New agent alone
• Combining new agents
• Combining new agent with standard
chemotherapy
8. Pharmacokinetics (PKs)
• Tests how rapidly a drug is cleared from
circulation
• Challenging for patients because can
sometimes require long days and multiple
visits a week during the first cycle of therapy
9. Early Drug Development Center
(EDDC)
• Conducts research dedicated to studying new drugs
• Specializes in phase I clinical trials
• Has over 30 phase I studies, some of which are open to
patients with all solid tumors, and a few of which are
specific to breast cancer
• You may be referred to the EDDC to discuss trial
possibilities
• If you go on a study, you will be followed within the
EDDC, but will also continue to have your original
oncologist/team involved in your care
10. Trials of Interest for Breast Cancer
• BRCA Carriers
– Rucaparib
– Veliparib and Irinotecan
– Sapacitabine and Seleciclib
• ER+ Breast Cancer
– Cdk 4/6 inhibitors
• Triple-negative Breast Cancer
– Mek/akt
– Cdk/parp
– PDL1 Antibody (immunotherapy)
12. PARP Inhibitor Studies
• Rucaparib
– PARP inhibitor given alone
• Veliparib + Irinotecan
– PARP inhibitor given with chemotherapy
• Olaparib + BKM120
– In breast cancer group, combines PARP with PI3K
inhibitor
18. Conclusions
• Exciting time in drug development
• Several phase I clinical trial options for
patients with varying subtypes of breast
cancer
• Many trials require tissue prescreening with a
goal of trying to deliver personalized medicine
23. • Each trial is different, but generally most
phase I studies have at least weekly visits for
the first cycle (3-4 weeks) then fewer visits
thereafter
27. Weigh Pros and Cons
Pros:
• If a new treatment is proven to work and you are receiving it,
you may be among the first to benefit
• You can expand the number of treatment options you have
• You have a chance to help others and improve cancer care
Cons:
• New treatments may have side effects that doctors do not
expect
• Phase I trials often involve frequent visits during the first cycle
• Even if a new treatment has benefits, it may not work for you
29. • Generally, almost all insurance companies pay
for patients to participate in phase I clinical
trials
• Anything that is for research purposes (ie.
research blood, biopsies) is provided by
research
• Experimental medication is provided