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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NM-3 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| MTD of NM-3 is the dose at which less than or equal to 1 of 6 patients experiences a DLT |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-tumor activity | ||
| VEGF and bFGF in urine, plasma and serum | ||
| Circulating endothelial cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston | Massachusetts | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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