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Last Updated: October 24, 2020

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CLINICAL TRIALS PROFILE FOR AFINITOR

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505(b)(2) Clinical Trials for Afinitor

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT02520063 Preoperative Combination of Letrozole, Everolimus, and TRC105 in Postmenopausal Hormone-Receptor Positive and Her2 Negative Breast Cancer Recruiting Novartis Pharmaceuticals Phase 1/Phase 2 2016-02-01 This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast cancers while everolimus blocks signals that drive cancer cells to grow. TRC105 is an investigational drug that blocks the formation and growth of blood vessels that feed the cancer and promote its growth. The goal of this study is to investigate the safety and efficacy of this multitargeted approach in breast cancer.
New Combination NCT02520063 Preoperative Combination of Letrozole, Everolimus, and TRC105 in Postmenopausal Hormone-Receptor Positive and Her2 Negative Breast Cancer Recruiting Tracon Pharmaceuticals Inc. Phase 1/Phase 2 2016-02-01 This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast cancers while everolimus blocks signals that drive cancer cells to grow. TRC105 is an investigational drug that blocks the formation and growth of blood vessels that feed the cancer and promote its growth. The goal of this study is to investigate the safety and efficacy of this multitargeted approach in breast cancer.
New Combination NCT02520063 Preoperative Combination of Letrozole, Everolimus, and TRC105 in Postmenopausal Hormone-Receptor Positive and Her2 Negative Breast Cancer Recruiting University of Alabama at Birmingham Phase 1/Phase 2 2016-02-01 This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast cancers while everolimus blocks signals that drive cancer cells to grow. TRC105 is an investigational drug that blocks the formation and growth of blood vessels that feed the cancer and promote its growth. The goal of this study is to investigate the safety and efficacy of this multitargeted approach in breast cancer.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Afinitor

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00081874 RAD001 in Relapsed or Refractory AML, ALL, CML in Blastic-Phase, Agnogenic Myeloid Metaplasia, CLL, T-Cell Leukemia, or Mantle Cell Lymphoma Completed Novartis Phase 1/Phase 2 2004-04-01 The goal of this clinical research study is to find the highest safe dose of RAD001 that can be given as a treatment for leukemia, mantle cell lymphoma, or myelofibrosis. Another goal is to learn how effective the dose that is found is as a treatment.
NCT00081874 RAD001 in Relapsed or Refractory AML, ALL, CML in Blastic-Phase, Agnogenic Myeloid Metaplasia, CLL, T-Cell Leukemia, or Mantle Cell Lymphoma Completed M.D. Anderson Cancer Center Phase 1/Phase 2 2004-04-01 The goal of this clinical research study is to find the highest safe dose of RAD001 that can be given as a treatment for leukemia, mantle cell lymphoma, or myelofibrosis. Another goal is to learn how effective the dose that is found is as a treatment.
NCT00303732 Vatalanib and Everolimus in Treating Patients With Advanced Solid Tumors Completed Novartis Phase 1 2004-12-01 RATIONALE: Vatalanib and everolimus may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of vatalanib and everolimus and to see how well they work in treating patients with advanced solid tumors.
NCT00303732 Vatalanib and Everolimus in Treating Patients With Advanced Solid Tumors Completed Daniel George, MD Phase 1 2004-12-01 RATIONALE: Vatalanib and everolimus may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of vatalanib and everolimus and to see how well they work in treating patients with advanced solid tumors.
NCT00331409 Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer Completed National Cancer Institute (NCI) Phase 2 2006-01-01 RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Everolimus may also block blood flow to the tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib mesylate works in treating patients with metastatic or unresectable kidney cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Afinitor

Condition Name

Condition Name for Afinitor
Intervention Trials
Breast Cancer 13
Metastatic Breast Cancer 7
Unspecified Adult Solid Tumor, Protocol Specific 6
Neuroendocrine Tumors 5
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Condition MeSH

Condition MeSH for Afinitor
Intervention Trials
Carcinoma 31
Breast Neoplasms 30
Carcinoma, Renal Cell 26
Neoplasms 19
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Clinical Trial Locations for Afinitor

Trials by Country

Trials by Country for Afinitor
Location Trials
United States 466
Italy 70
France 36
Spain 28
Canada 27
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Trials by US State

Trials by US State for Afinitor
Location Trials
Texas 47
California 24
Florida 20
Pennsylvania 19
New York 18
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Clinical Trial Progress for Afinitor

Clinical Trial Phase

Clinical Trial Phase for Afinitor
Clinical Trial Phase Trials
Phase 4 7
Phase 3 14
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Afinitor
Clinical Trial Phase Trials
Recruiting 44
Completed 43
Active, not recruiting 39
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Clinical Trial Sponsors for Afinitor

Sponsor Name

Sponsor Name for Afinitor
Sponsor Trials
Novartis 42
Novartis Pharmaceuticals 34
National Cancer Institute (NCI) 25
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Sponsor Type

Sponsor Type for Afinitor
Sponsor Trials
Other 163
Industry 104
NIH 31
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Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Johnson and Johnson
Mallinckrodt
Dow
Medtronic

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