Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511576
Status:
TERMINATED
Last Update Posted:
2015-01-08
First Post:
2007-08-03
Brief Title:
Study to Evaluate Combination Treatment of MGCD0103 and Docetaxel Taxotere for Subjects With Advanced Cancer Tumors
Sponsor:
Mirati Therapeutics Inc
Organization:
Mirati Therapeutics Inc
Study Overview
Official Title:
A Phase 1 Open-Label Dose-Escalation Trial to Evaluate the Safety Pharmacokinetics and Pharmacodynamics of MGCD0103 MG-0103 in Combination With Docetaxel Taxotere in Subjects With Advanced Solid Malignancies
Status:
TERMINATED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Celgene terminated its collaboration agreement with MethylGene for the development of MGCD0103 All Celgene-sponsored trials with MGCD0103 will be closed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the combination of an experimental drug known as MGCD0103 given along with an FDA-approved drug called docetaxel This is a Phase 1 study that will look at different doses of MGCD0103 given along with docetaxel in order to better understand the effects positive and negative of this combination on the subjects body and disease
The study would like to find the following information
How long MGCD0103 and docetaxel stay in the subjects body
What effects good andor bad MGCD0103 and docetaxel have on the subject and on hisher cancer and
If the genetic and chemical make-up of the subjects blood cells and tumor cells play a role in how you respond or do not respond to MGCD0103 and docetaxel
The study would like to find the following information
How long MGCD0103 and docetaxel stay in the subjects body
What effects good andor bad MGCD0103 and docetaxel have on the subject and on hisher cancer and
If the genetic and chemical make-up of the subjects blood cells and tumor cells play a role in how you respond or do not respond to MGCD0103 and docetaxel
Detailed Description:
This Phase 1 study will evaluate escalating doses of orally administered MGCD0103 in combination with two fixed doses 60 mgm2 and 75 mgm2 of IV docetaxel In the US docetaxel is recommended at these or even higher doses up to 100 mgm2 both as a single agent or in combination with other cytotoxic drugs eg cisplatin doxorubicin cyclophosphamide and 5-fluorouracil for the treatment of NSCLC prostate cancer gastric adenocarcinoma and head and neck cancer In Japan 60 mgm2 IV docetaxel is the approved dose for the treatment of breast cancer
MGCD0103 belongs to the class of more selective less globally cytotoxic agents being investigated for treatment of cancers today and may offer a lesser andor non-overlapping toxicity profile than the cytotoxic agents with which docetaxel is currently combined MGCD0103 doses ranging from 50 to 135 mg have been administered in combination with the approved regimen of azacitidine Vidaza 75 mgm2day for 5 days every 4 weeks to patients with high-risk MDS and AML A 50 mg dose of MGCD0103 has been administered in combination with the approved regimen of gemcitabine 1000 mgm2 once weekly for 3 consecutive weeks of each 4-week cycle to patients with advanced solid tumors higher doses of MGCD0103 will soon be evaluated in that trial
Given the above the proposed starting dose of 60 mgm2 IV docetaxel and 50 mg MGCD0103 is considered appropriately safe for initial investigation of this combination Based on the results observed in Part 1 the study may also evaluate 75 mgm2 IV docetaxel and escalating doses of orally administered MGCD0103 in Part 2 in order to determine whether this dosing regimen is safe and would also warrant further investigation
MGCD0103 belongs to the class of more selective less globally cytotoxic agents being investigated for treatment of cancers today and may offer a lesser andor non-overlapping toxicity profile than the cytotoxic agents with which docetaxel is currently combined MGCD0103 doses ranging from 50 to 135 mg have been administered in combination with the approved regimen of azacitidine Vidaza 75 mgm2day for 5 days every 4 weeks to patients with high-risk MDS and AML A 50 mg dose of MGCD0103 has been administered in combination with the approved regimen of gemcitabine 1000 mgm2 once weekly for 3 consecutive weeks of each 4-week cycle to patients with advanced solid tumors higher doses of MGCD0103 will soon be evaluated in that trial
Given the above the proposed starting dose of 60 mgm2 IV docetaxel and 50 mg MGCD0103 is considered appropriately safe for initial investigation of this combination Based on the results observed in Part 1 the study may also evaluate 75 mgm2 IV docetaxel and escalating doses of orally administered MGCD0103 in Part 2 in order to determine whether this dosing regimen is safe and would also warrant further investigation
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