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The purpose of this study is to determine a safe dose of XL844 in combination with gemcitabine, how often it should be taken, and how well people with cancer tolerate the combination of gemcitabine and XL844.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XL844 | Drug | Gelatin capsules supplied as 5-mg, 25-mg, and 100-mg strengths; twice-weekly dosing. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of XL844 as a single agent and in combination with gemcitabine when administered orally to subjects with advanced malignancies | Assessed at each visit/periodic visits | |
| Determine the Combination maximum tolerated dose and dose-limiting toxicities for XL844 alone and in combination with gemcitabine | Assessed at periodic visits | |
| Evaluate plasma pharmacokinetics and estimate renal elimination of XL844 as a single agent and in combination with gemcitabine | Assessed at periodic visits |
| Measure | Description | Time Frame |
|---|---|---|
| (Exploratory:) Assess tumor response after repeated administration of XL844 in combination with gemcitabine in subjects with advanced malignancies | Assessed at periodic visits | |
| Pharmacodynamic correlates of XL844 activity in tumor tissue | Assessed at periodic visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States | ||
| M.D. Anderson Cancer Center |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine |
| Drug |
once-weekly 30-minute IV infusion |
|
| Houston |
| Texas |
| 77030 |
| United States |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |