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This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy. After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKM-080301 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TKM-080301 | Drug | Repeat dose IV infusion. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of treatment with TKM-080301 | 6 months | |
| Determine dose-limiting toxicities and maximum tolerated dose of TKM-080301 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the pharmacokinetics of TKM-080301 | 2 months | |
| Assess preliminary evidence of anti-tumor activity | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Kowalski, MD | Tekmira Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Healthcare Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| Mayo Clinic Arizona |
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| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-2800 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Westchase Oncology Center | Houston | Texas | 77042 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D018358 | Neuroendocrine Tumors |
| D018268 | Adrenocortical Carcinoma |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D002276 | Carcinoid Tumor |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D000306 | Adrenal Cortex Neoplasms |
| D000310 | Adrenal Gland Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D000303 | Adrenal Cortex Diseases |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000708202 | TKM-080301 |
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