Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217815
Status:
COMPLETED
Last Update Posted:
2008-07-15
First Post:
2005-09-15
Brief Title:
Preliminary Study of Mycograb and Docetaxel in Advanced Breast Cancer
Sponsor:
NeuTec Pharma
Organization:
NeuTec Pharma
Study Overview
Official Title:
A Phase Ib Pharmacokinetic Multiple Center Open Label Study Evaluating the Safety and Efficacy of Mycograb Administered IV in Combination With Docetaxel in Metastatic or Recurrent Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study hypothesis is that the addition of Mycograb to docetaxel will improve outcome in advanced carcinoma of the breast
Detailed Description:
Combination therapies that incorporate new agents have demonstrated the potential to improve outcome for patients with metastatic breast carcinoma Docetaxel has been shown to be a very active drug in breast cancer and anthracycline-based chemotherapy combinations represent the most active form of therapy generating objective response rates of between 40-70 Mycograb was most effective in breast carcinoma cell lines in combination with cisplatin docetaxel and anthracyclines doxorubicin daunorubicin
We propose that Mycograb binds to hsp90 inhibiting hsp90 chaperone functioning and resulting in the destabilization of key proteins including estrogensteroid receptors nitric oxide synthase ras1 MAP Mitogen-activated protein kinase Src Erb-B2erythroblastic leukemia viral oncogene homolog 2 HERhuman estrogen receptor kinases and EGFR epidermal grown factor receptor Over expression of HER2 receptors are observed in malignancies such as breast cancer and reportedly have been associated with resistance to chemotherapeutic agents Both maturing and fully mature forms of the receptor depend on hsp90 association for stability Inhibition of hsp90 function down regulates AKT kinase and Src kinase which are non-receptor kinase Therefore Mycograb may be of use in estrogen dependent and hormone independent breast cancers
Mycograb has been demonstrated to have anti-tumor activity in cell culture The 50 cytotoxicity of Mycograb on its own is 50 Combination therapies that incorporate new agents have demonstrated the potential to improve outcome for patients with metastatic breast carcinoma Docetaxel has been shown to be a very active drug in breast cancer and anthracycline-based chemotherapy combinations represent the most active form of therapy generating objective response rates of between 40-70 Mycograb was most effective in breast carcinoma cell lines in combination with cisplatin docetaxel and anthracyclines doxorubicin daunorubicin
We propose that Mycograb binds to hsp90 inhibiting hsp90 chaperone functioning and resulting in the destabilization of key proteins including estrogensteroid receptors nitric oxide synthase ras1 MAP kinase Src Erb-B2 HER kinases and EGFR Overexpression of HER2 receptors are observed in malignancies such as breast cancer and reportedly have been associated with resistance to chemotherapeutic agents Both maturing and fully mature forms of the receptor depend on hsp90 association for stability Inhibition of hsp90 function down regulates AKT kinase and Src kinase which are non-receptor kinase Therefore Mycograb may be of use in estrogen dependent and hormone independent breast cancers
Mycograb has been demonstrated to have anti-tumor activity in cell culture The 50 cytotoxicity of Mycograb on its own is 50 µgml MCF7 Breast cancer cell line designation Mycograb in combination with docetaxel doxorubicin and cisplatin and Herceptin increased the cytotoxicity in breast cancer cells
It is appropriate to evaluate the apparent tumor response and survivor benefits resulting from the addition of Mycograb to a docetaxel containing chemotherapy regimen in metastatic or recurrent breast cancer patients
MCF7 Mycograb in combination with docetaxel doxorubicin and cisplatin and Herceptin increased the cytotoxicity in breast cancer cells
It is appropriate to evaluate the apparent tumor response and survivor benefits resulting from the addition of Mycograb to a docetaxel containing chemotherapy regimen in metastatic or recurrent breast cancer patients
We propose that Mycograb binds to hsp90 inhibiting hsp90 chaperone functioning and resulting in the destabilization of key proteins including estrogensteroid receptors nitric oxide synthase ras1 MAP Mitogen-activated protein kinase Src Erb-B2erythroblastic leukemia viral oncogene homolog 2 HERhuman estrogen receptor kinases and EGFR epidermal grown factor receptor Over expression of HER2 receptors are observed in malignancies such as breast cancer and reportedly have been associated with resistance to chemotherapeutic agents Both maturing and fully mature forms of the receptor depend on hsp90 association for stability Inhibition of hsp90 function down regulates AKT kinase and Src kinase which are non-receptor kinase Therefore Mycograb may be of use in estrogen dependent and hormone independent breast cancers
Mycograb has been demonstrated to have anti-tumor activity in cell culture The 50 cytotoxicity of Mycograb on its own is 50 Combination therapies that incorporate new agents have demonstrated the potential to improve outcome for patients with metastatic breast carcinoma Docetaxel has been shown to be a very active drug in breast cancer and anthracycline-based chemotherapy combinations represent the most active form of therapy generating objective response rates of between 40-70 Mycograb was most effective in breast carcinoma cell lines in combination with cisplatin docetaxel and anthracyclines doxorubicin daunorubicin
We propose that Mycograb binds to hsp90 inhibiting hsp90 chaperone functioning and resulting in the destabilization of key proteins including estrogensteroid receptors nitric oxide synthase ras1 MAP kinase Src Erb-B2 HER kinases and EGFR Overexpression of HER2 receptors are observed in malignancies such as breast cancer and reportedly have been associated with resistance to chemotherapeutic agents Both maturing and fully mature forms of the receptor depend on hsp90 association for stability Inhibition of hsp90 function down regulates AKT kinase and Src kinase which are non-receptor kinase Therefore Mycograb may be of use in estrogen dependent and hormone independent breast cancers
Mycograb has been demonstrated to have anti-tumor activity in cell culture The 50 cytotoxicity of Mycograb on its own is 50 µgml MCF7 Breast cancer cell line designation Mycograb in combination with docetaxel doxorubicin and cisplatin and Herceptin increased the cytotoxicity in breast cancer cells
It is appropriate to evaluate the apparent tumor response and survivor benefits resulting from the addition of Mycograb to a docetaxel containing chemotherapy regimen in metastatic or recurrent breast cancer patients
MCF7 Mycograb in combination with docetaxel doxorubicin and cisplatin and Herceptin increased the cytotoxicity in breast cancer cells
It is appropriate to evaluate the apparent tumor response and survivor benefits resulting from the addition of Mycograb to a docetaxel containing chemotherapy regimen in metastatic or recurrent breast cancer patients
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