Ignite Creation Date:
2024-05-05 @ 10:29 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01118975
Status:
TERMINATED
Last Update Posted:
2019-11-13
First Post:
2010-05-05
Brief Title:
GCC 0845Vorinostat and Lapatinib in Advanced Solid Tumors and Advanced Breast Cancer to Evaluate Response and Biomarkers
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
GCC 0845 Pilot and Phase II- Vorinostat and Lapatinib in Patients With Advanced Solid Tumor Malignancies and Women With Recurrent Local-Regional or Metastatic Breast Cancer to Evaluate Response and Biomarkers of EMT and Breast Cancer Stem Cells
Status:
TERMINATED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lost sponsorship for study drug
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research is being done to find out how safe and how well the combination of lapatinib and vorinostat works against advanced cancers
Detailed Description:
Lapatinib is an anti-cancer drug that is approved by the Food and Drug Administration FDA for the treatment of metastatic HER2-positive breast cancer HER2 is a protein involved in the growth of some cancer cells In lab tests and small clinical studies lapatinib is also found to kill other types of cancer that have another related protein called epidermal growth factor receptor EGFR For participants who have other cancers the use of lapatinib in this study is investigational This means the drug is not FDA approved for this use
Vorinostat is only FDA approved for the treatment of cutaneous T cell lymphoma a type of cancer Vorinostat is not currently FDA approved for breast cancer or any other type of cancer The use of vorinostat in this study is investigational
Cancer cells can travel through the blood stream and spread to other organs This process is called metastasis Lab tests and small clinical trials have shown that vorinostat kills some cancer cells and prevents these cancer cells from traveling through the blood stream These trials have shown that vorinostat improves how well lapatinib kills cancer cells
Newer studies have also shown that a subset of cells called cancer stem cells can come back spread and become resistant to the usual chemotherapy In laboratory tests we found that vorinostat and lapatinib can reduce the number of cancer stem cells We are looking at combining vorinostat and lapatinib in the hope that we can reduce the number of cancer stem cells and cancer cells traveling through the blood stream
There are two parts to this study
First part- We want to learn more about the best dose of vorinostat to be given with lapatinib We want to learn about how much vorinostat and lapatinib goes into the blood during treatment We also want to learn the side effects safety of the combination of vorinostat and lapatinib All patients will receive the FDA-approved dose of lapatinib The first group of patients will get a slightly lower dose of vorinostat than is given normally If the side effects are not too serious the next group of patients will get the dose of vorinostat that is given normally
Second part- We will find out how well the combination of vorinostat and lapatinib works in patients with HER2-positive metastatic breast cancer
Vorinostat is only FDA approved for the treatment of cutaneous T cell lymphoma a type of cancer Vorinostat is not currently FDA approved for breast cancer or any other type of cancer The use of vorinostat in this study is investigational
Cancer cells can travel through the blood stream and spread to other organs This process is called metastasis Lab tests and small clinical trials have shown that vorinostat kills some cancer cells and prevents these cancer cells from traveling through the blood stream These trials have shown that vorinostat improves how well lapatinib kills cancer cells
Newer studies have also shown that a subset of cells called cancer stem cells can come back spread and become resistant to the usual chemotherapy In laboratory tests we found that vorinostat and lapatinib can reduce the number of cancer stem cells We are looking at combining vorinostat and lapatinib in the hope that we can reduce the number of cancer stem cells and cancer cells traveling through the blood stream
There are two parts to this study
First part- We want to learn more about the best dose of vorinostat to be given with lapatinib We want to learn about how much vorinostat and lapatinib goes into the blood during treatment We also want to learn the side effects safety of the combination of vorinostat and lapatinib All patients will receive the FDA-approved dose of lapatinib The first group of patients will get a slightly lower dose of vorinostat than is given normally If the side effects are not too serious the next group of patients will get the dose of vorinostat that is given normally
Second part- We will find out how well the combination of vorinostat and lapatinib works in patients with HER2-positive metastatic breast cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None