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Sponsors and Collaborators: |
Penn State University Novartis |
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Information provided by: | Penn State University |
ClinicalTrials.gov Identifier: | NCT00827567 |
The hypothesis of this clinical research study is to discover if the study drug RAD001 can shrink or slow the growth of ER/PR negative or Her2 Neu negative breast cancer. The safety of RAD001 will also be studied.
Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if RAD001 is safe and effective.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: RAD 001 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of RAD001 in Triple Negative Metastatic Breast Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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RAD 001: Experimental
RAD001-10 mg by mouth once everyday
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Drug: RAD 001
RAD 001-10 mg by mouth once everyday
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RAD001 is an orally administered cell cycle inhibitor with antitumor activity. RAD001, like Rapamycin, binds with high affinity to an intracellular immunophilin, FKBP12 and this complex specifically interacts with the mammalian target of rapamycin (mTOR) protein kinase, inhibiting downstream events such as the initiation of mRNA translation. RAD001 inhibits the growth of a wide range of histologically diverse tumor cells. RAD001 is being developed as a cytostatic agent to delay the time to tumor recurrence/progression or to increase survival in patients with various malignancies. The compound has good tolerability, a partially discovered mechanism of action. RAD001 has the ability to arrest cells in the G1 phase, and the ability to induce apoptosis. RAD001 is being investigated as an anticancer agent based on its potential to act directly on the tumor cells by inhibiting tumor cell growth and proliferation through possible inhibition of the PI3/AKT/MTOR pathway.
RAD001 was shown to have activity in human tumor cell lines originating from lung, breast, prostate, colon, kidney, melanoma and glioblastoma. RAD001 was also shown to have activity in human pancreatic neuroendocrine cells, where induction of apoptosis was reported, as well as in acute myeloid leukemia cells, adult T-cell leukemia cells, diffuse large B cell lymphoma cells, pancreatic tumor cells, ovarian cancer cells, and hepatocellular carcinoma cells.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Allan Lipton, MD | 717-531-8870 | alipton@psu.edu |
Contact: Cynthia Campbell Baird, RN OCN | 717-531-5777 | cbaird@psu.edu |
United States, Pennsylvania | |
Penn State Milton S. Hershey Medical Center | Recruiting |
Hershey, Pennsylvania, United States, 17033 | |
Contact: Allan Lipton, MD 717-531-8870 alipton@psu.edu | |
Contact: Cynthia Campbell Baird, RN OCN 717-531-5777 cbaird@psu.edu | |
Sub-Investigator: H.P. DeGreen, DO | |
Sub-Investigator: Harold Harvey, MD | |
Sub-Investigator: Leah Cream, MD | |
Sub-Investigator: Cynthia Campbell Baird, RN OCN | |
Sub-Investigator: Jennifer Bree Kelly, RN BSN |
Principal Investigator: | Allan Lipton, MD | Penn State Milton S. Hershey |
Responsible Party: | Penn State College of Medicine, Penn State Milton S. Hershey Medical Center ( Allan Lipton, MD ) |
Study ID Numbers: | RAD001JUS48T |
Study First Received: | January 21, 2009 |
Last Updated: | July 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00827567 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Breast cancer metastatic breast triple negative ER/PR negative Her2 Neu negative |
Everolimus Immunologic Factors Skin Diseases |
Breast Neoplasms Immunosuppressive Agents Breast Diseases |
Everolimus Neoplasms Neoplasms by Site Immunologic Factors Skin Diseases |
Physiological Effects of Drugs Breast Neoplasms Immunosuppressive Agents Pharmacologic Actions Breast Diseases |