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Phase I Clinical Trials

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Phase I Clinical Trials

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  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?

  4. Road To FDA Approval FDA Approval Preclinical Phase 1 Phase 2 Phase 3

  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

  7. 3 Patients 3 Patients 3 Patients 10 mg 20 mg 30 mg Dose Escalation in Phase 1 Studies: 3+3 Design Once dose determined EXPANSION COHORT Enroll 10-20 patients

  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)

  11. PARP Inhibitors Igelhart JD and Silver DP. NEJM 2009

  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

  13. Sapacitabine + Seleciclib • Sapacitabine: oral chemotherapy • Seleciclib: oral cdk 1,2, 7, 9 inhibitor

  14. CDK 4/6 Inhibitors

  15. Progression-Free Survival 1.0 0.9 0.8 0.7 0.6 Progression-Free Survival Probability 0.5 0.4 0.3 0.2 0.1 0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 Time (Month) Number of patients at risk PD991+LET 84 75 60 53 43 35 25 18 15 14 9 5 3 1 LET 81 57 38 29 22 17 11 6 5 4 3 3 1 1

  16. Ongoing studies with cdk 4/6 inhibitors • LEE011 • Cdk 4/6 inhibitor given alone, in expansion phase • Lilly cdk 4/6 inhibitor + faslodex

  17. Triple-negative Breast Cancer • PI3K inhibition • GDC-0973/GDC-0068 (MEK/Akt inhibitors) • BKM120 (phase 2) • Dinaciclib/Veliparib • Cdk + PARP • Immunotherapy • PDL1 Antibody

  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

  19. Common Questions

  20. Will I get a placebo?

  21. No-- phase I trials do not administer placebos

  22. How often will I need to come in for visits?

  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

  24. How will you know if the drug is working?

  25. Frequency of imaging is dependent on the study, but generally every 6-9 weeks

  26. Why should I do a clinical trial?

  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

  28. Will my insurance pay for me to participate in the trial?

  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

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