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Last Updated: November 23, 2020

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CLINICAL TRIALS PROFILE FOR TYKERB

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505(b)(2) Clinical Trials for Tykerb

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
OTC NCT00496366 Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer Active, not recruiting National Cancer Institute (NCI) Phase 2 2007-07-01 Subjects with advanced or metastatic (spread to other parts of the body) breast cancer that is HER2/neu-positive will take part in this study. This type of breast cancer has a high amount of a protein called HER2. HER2 is part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types. The purpose of this research study is to compare an approved treatment for breast cancer capecitabine, also called Xeloda®, to the combination of capecitabine plus an experimental drug, lapatinib also known as Tykerb®, for treatment of advanced or metastatic breast cancer that is HER2/neu-positive.Capecitabine is an approved type of chemotherapy used to treat certain cancers including breast cancer. Capecitabine fights cancer by interfering with the ability of cells to divide and tumor growth. Lapatinib (Tykerb®) is considered "investigational", which means the drug has not been approved by the US Food and Drug Administration (FDA) for sale as a prescription or over-the-counter medication. Lapatinib may slow or stop cancer cells from growing by inhibiting the growth of cancer cells. However, this theory has not been proven. The addition of the study drug (lapatinib) to capecitabine may help stop cancer cells as well as or better than capecitabine alone. Other studies have demonstrated activity and tolerability of lapatinib either alone or in combination with capecitabine in the treatment of breast cancer.Subjects will receive capecitabine and lapatinib. A treatment period will be 21 days long. This period is known as a "cycle". All medications will be given by mouth. Subjects will take capecitabine for 2 weeks straight (Day 1-14) followed by a 1 week without capecitabine (Day 15-21). Doses of lapatinib will be taken daily continuously for 21 days (Day 1-Day 21) which means that subjects will still take lapatinib on the week that they do not take capecitabine (Day 15-21). Subjects will continue to receive these medications unless they experience severe, serious and/or excessive side effects, the cancer becomes worse, the subjects wishes to no longer participate or the study doctor feels it is not in the best interest to continue treatment.Tests and procedures such as physical exam, blood tests, CT or MRI, ECG, ECHO and/or MUGA tests will be conducted at one or more of the following time points: before the study starts, before each cycle, every 6 and 12 weeks, and after the last dose of capecitabine/lapatinib treatment.
OTC NCT00496366 Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer Active, not recruiting Rutgers Cancer Institute of New Jersey Phase 2 2007-07-01 Subjects with advanced or metastatic (spread to other parts of the body) breast cancer that is HER2/neu-positive will take part in this study. This type of breast cancer has a high amount of a protein called HER2. HER2 is part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types. The purpose of this research study is to compare an approved treatment for breast cancer capecitabine, also called Xeloda®, to the combination of capecitabine plus an experimental drug, lapatinib also known as Tykerb®, for treatment of advanced or metastatic breast cancer that is HER2/neu-positive.Capecitabine is an approved type of chemotherapy used to treat certain cancers including breast cancer. Capecitabine fights cancer by interfering with the ability of cells to divide and tumor growth. Lapatinib (Tykerb®) is considered "investigational", which means the drug has not been approved by the US Food and Drug Administration (FDA) for sale as a prescription or over-the-counter medication. Lapatinib may slow or stop cancer cells from growing by inhibiting the growth of cancer cells. However, this theory has not been proven. The addition of the study drug (lapatinib) to capecitabine may help stop cancer cells as well as or better than capecitabine alone. Other studies have demonstrated activity and tolerability of lapatinib either alone or in combination with capecitabine in the treatment of breast cancer.Subjects will receive capecitabine and lapatinib. A treatment period will be 21 days long. This period is known as a "cycle". All medications will be given by mouth. Subjects will take capecitabine for 2 weeks straight (Day 1-14) followed by a 1 week without capecitabine (Day 15-21). Doses of lapatinib will be taken daily continuously for 21 days (Day 1-Day 21) which means that subjects will still take lapatinib on the week that they do not take capecitabine (Day 15-21). Subjects will continue to receive these medications unless they experience severe, serious and/or excessive side effects, the cancer becomes worse, the subjects wishes to no longer participate or the study doctor feels it is not in the best interest to continue treatment.Tests and procedures such as physical exam, blood tests, CT or MRI, ECG, ECHO and/or MUGA tests will be conducted at one or more of the following time points: before the study starts, before each cycle, every 6 and 12 weeks, and after the last dose of capecitabine/lapatinib treatment.
OTC NCT00496366 Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer Active, not recruiting Rutgers, The State University of New Jersey Phase 2 2007-07-01 Subjects with advanced or metastatic (spread to other parts of the body) breast cancer that is HER2/neu-positive will take part in this study. This type of breast cancer has a high amount of a protein called HER2. HER2 is part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types. The purpose of this research study is to compare an approved treatment for breast cancer capecitabine, also called Xeloda®, to the combination of capecitabine plus an experimental drug, lapatinib also known as Tykerb®, for treatment of advanced or metastatic breast cancer that is HER2/neu-positive.Capecitabine is an approved type of chemotherapy used to treat certain cancers including breast cancer. Capecitabine fights cancer by interfering with the ability of cells to divide and tumor growth. Lapatinib (Tykerb®) is considered "investigational", which means the drug has not been approved by the US Food and Drug Administration (FDA) for sale as a prescription or over-the-counter medication. Lapatinib may slow or stop cancer cells from growing by inhibiting the growth of cancer cells. However, this theory has not been proven. The addition of the study drug (lapatinib) to capecitabine may help stop cancer cells as well as or better than capecitabine alone. Other studies have demonstrated activity and tolerability of lapatinib either alone or in combination with capecitabine in the treatment of breast cancer.Subjects will receive capecitabine and lapatinib. A treatment period will be 21 days long. This period is known as a "cycle". All medications will be given by mouth. Subjects will take capecitabine for 2 weeks straight (Day 1-14) followed by a 1 week without capecitabine (Day 15-21). Doses of lapatinib will be taken daily continuously for 21 days (Day 1-Day 21) which means that subjects will still take lapatinib on the week that they do not take capecitabine (Day 15-21). Subjects will continue to receive these medications unless they experience severe, serious and/or excessive side effects, the cancer becomes worse, the subjects wishes to no longer participate or the study doctor feels it is not in the best interest to continue treatment.Tests and procedures such as physical exam, blood tests, CT or MRI, ECG, ECHO and/or MUGA tests will be conducted at one or more of the following time points: before the study starts, before each cycle, every 6 and 12 weeks, and after the last dose of capecitabine/lapatinib treatment.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Tykerb

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00095563 Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers Completed National Cancer Institute (NCI) Phase 2 2004-09-01 Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent and/or metastatic adenoid cystic cancer or other salivary gland cancers. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
NCT00095667 Lapatinib in Treating Patients With Recurrent or Metastatic Prostate Cancer Completed National Cancer Institute (NCI) Phase 2 2004-11-01 Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent or metastatic prostate cancer.
NCT00095940 Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors Completed National Cancer Institute (NCI) Phase 1/Phase 2 2004-10-01 This phase I/II trial studies lapatinib to see how well it works in treating young patients with recurrent or refractory central nervous system (CNS) tumors. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tykerb

Condition Name

Condition Name for Tykerb
Intervention Trials
Stage IV Breast Cancer 11
Breast Cancer 10
Stage IIIC Breast Cancer 7
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Condition MeSH

Condition MeSH for Tykerb
Intervention Trials
Breast Neoplasms 34
Carcinoma 13
Breast Neoplasms, Male 7
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Clinical Trial Locations for Tykerb

Trials by Country

Trials by Country for Tykerb
Location Trials
United States 280
Germany 17
United Kingdom 11
Canada 11
Korea, Republic of 10
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Trials by US State

Trials by US State for Tykerb
Location Trials
California 17
Texas 15
Pennsylvania 13
Ohio 11
New York 11
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Clinical Trial Progress for Tykerb

Clinical Trial Phase

Clinical Trial Phase for Tykerb
Clinical Trial Phase Trials
Phase 3 3
Phase 2/Phase 3 1
Phase 2 31
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Clinical Trial Status

Clinical Trial Status for Tykerb
Clinical Trial Phase Trials
Completed 30
Active, not recruiting 13
Terminated 7
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Clinical Trial Sponsors for Tykerb

Sponsor Name

Sponsor Name for Tykerb
Sponsor Trials
National Cancer Institute (NCI) 30
GlaxoSmithKline 19
Novartis 4
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Sponsor Type

Sponsor Type for Tykerb
Sponsor Trials
Other 34
NIH 30
Industry 29
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