A Study of NM-3 Administered Orally in Patients With Advanced Solid Tumors.
A study for patients who have failed standard therapy. If there is no dose limiting toxicities the patients will receive further cycles of therapy if there is no evidence of disease progression.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I and Pharmacokinetic Study of NM-3 Administered Orally Once or Twice Daily on Five Consecutive Days and Repeated Weekly for Six Weeks Every Eight Weeks in Patients With Advanced Solid Tumors.|
- MTD of NM-3 is the dose at which less than or equal to 1 of 6 patients experiences a DLT
- Anti-tumor activity
- VEGF and bFGF in urine, plasma and serum
- Circulating endothelial cells
|Study Start Date:||May 2001|
|Study Completion Date:||October 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
This is a non-randomized, open-label, Phase I study. A modified Fibonacci dose escalation will be used to determine the MTD for subsequent Phase II trials. Study duration is expected to be 12 to 18 months. Patients with a histological or cytological diagnosis of a solid tumor who have failed standard therapy or for whom no standard therapy exists are enrolled. If there is no dose limiting toxicities and if patients meet the inclusion criteria and have none of the exclusion criteria of the protocol, they will receive further cycles of therapy if there is no evidence of disease progression.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046696
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|