Ignite Creation Date:
2024-05-06 @ 1:14 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01763710
Status:
COMPLETED
Last Update Posted:
2016-03-29
First Post:
2012-12-14
Brief Title:
Neurotoxicity Characterization Study of Nab-paclitaxel Versus Conventional Paclitaxel in Metastatic Breast Cancer
Sponsor:
Fundacion Oncosur
Organization:
Fundacion Oncosur
Study Overview
Official Title:
Neurotoxicity Characterization Phase II Randomized Study of Nab-paclitaxel Versus Conventional Paclitaxel as First-line Therapy of Metastatic HER2-negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-03
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:
neurabrax
Brief Summary:
Nanomedicines are currently being developed in the treatment of cancer due to their pharmacological advantages over traditional formulations they provide a shorter infusion time and lower risks of hypersensitivity reactions associated with commonly used solvents
Nab-paclitaxel is a nanoparticle albumin-bound particle form of paclitaxel that is thought to exploit natural albumin pathways to enhance the selective uptake and accumulation of paclitaxel at the site of the tumour thus reducing its diffusion to normal tissues
Nab-paclitaxel has been approved for the treatment of metastatic breast cancer patients who have failed first-line treatment for metastatic disease and for whom standard anthracycline-containing therapy is not indicated
SPARC is a cysteine rich acid protein that is overexpressed in a broad proportion of solid tumours Expression of this protein could sensitize tumour cells to antitumor activity of Nab-paclitaxel due to its union through albumin-binding to this protein
First-line clinical trials have been developed with different Nab-paclitaxel regimens and also in combination with different chemotherapies and trastuzumab showing a high level of efficacy
Toxicity profile of Nab-paclitaxel is well characterized with significantly less haematological toxicities compared with conventional paclitaxel
Nab-paclitaxel derived grade III neuropathy is short-lasting and more reversible than conventional paclitaxel-derived neuropathy probably due to absence of Cremophor solvent or due to paclitaxel itself
However there is still a lack of clinical and physiological characterisation of Nab-paclitaxel induced neuropathy
The current used tools for early detection and continuous evaluation of neurotoxicity are not optimal Most used toxicity scales are limited as they do not provide a detailed information of the severity of the neuropathy its impact on quality of life or physiopathology mechanisms
In addition an inter-individual variability exists in terms of neurotoxicity predisposition when taxanes are used it could be related to polymorphic differences in genes implicated in transport and metabolism of these drugs
Nab-paclitaxel is a nanoparticle albumin-bound particle form of paclitaxel that is thought to exploit natural albumin pathways to enhance the selective uptake and accumulation of paclitaxel at the site of the tumour thus reducing its diffusion to normal tissues
Nab-paclitaxel has been approved for the treatment of metastatic breast cancer patients who have failed first-line treatment for metastatic disease and for whom standard anthracycline-containing therapy is not indicated
SPARC is a cysteine rich acid protein that is overexpressed in a broad proportion of solid tumours Expression of this protein could sensitize tumour cells to antitumor activity of Nab-paclitaxel due to its union through albumin-binding to this protein
First-line clinical trials have been developed with different Nab-paclitaxel regimens and also in combination with different chemotherapies and trastuzumab showing a high level of efficacy
Toxicity profile of Nab-paclitaxel is well characterized with significantly less haematological toxicities compared with conventional paclitaxel
Nab-paclitaxel derived grade III neuropathy is short-lasting and more reversible than conventional paclitaxel-derived neuropathy probably due to absence of Cremophor solvent or due to paclitaxel itself
However there is still a lack of clinical and physiological characterisation of Nab-paclitaxel induced neuropathy
The current used tools for early detection and continuous evaluation of neurotoxicity are not optimal Most used toxicity scales are limited as they do not provide a detailed information of the severity of the neuropathy its impact on quality of life or physiopathology mechanisms
In addition an inter-individual variability exists in terms of neurotoxicity predisposition when taxanes are used it could be related to polymorphic differences in genes implicated in transport and metabolism of these drugs
Detailed Description:
None
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