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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Bayer | INDUSTRY |
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The purpose of this study is to evaluate the safety and tolerability and describe the maximum tolerated dose (MTD) of treatment with escalating doses of sorafenib in combination with bevacizumab and paclitaxel for patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib, Bevacizumab & Paclitaxel | Experimental | Paclitaxel is given as i.v infusion over 60 min on days 1, 8, 15 every 28 days. Sorafenib is given orally starting with cycle 1 day 2. Bevacizumab is given as i.v infusion on days 1 and 15 every 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib | Drug | Cohort 1 200 mg po BID D1-5; Cohort 2 200 mg po BID; Cohort 3 400 mg po BID D1-5 Cohort 4 400 mg po BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability and describe the maximum tolerated dose (MTD) of treatment with escalating doses of sorafenib in combination with bevacizumab and paclitaxel for patients with advanced solid tumors. | baseline through end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics of paclitaxel and sorafenib alone and in combination | baseline through end of treatment | |
| To evaluate pharmacodynamic changes a)in tumor vascular parameters and b)in plasma VEGF and soluble VEGF receptor levels, and correlate with clinical outcomes and sorafenib pharmacokinetic (PK) profile. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Safi G Shahda, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32847973 | Derived | Chiorean EG, Perkins SM, Strother RM, Younger A, Funke JM, Shahda SG, Hahn NM, Sandrasegaran K, Jones DR, Skaar TC, Schneider BP, Sweeney CJ, Matei DE. Phase I, Pharmacogenomic, Drug Interaction Study of Sorafenib and Bevacizumab in Combination with Paclitaxel in Patients with Advanced Refractory Solid Tumors. Mol Cancer Ther. 2020 Oct;19(10):2155-2162. doi: 10.1158/1535-7163.MCT-20-0277. Epub 2020 Aug 26. |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| baseline through end of treatment |
| To evaluate variants in genes of paclitaxel drug-metabolism and drug-transporters P glycoprotein and correlate with PK profile for paclitaxel and with clinical outcomes | baseline through end of treatment |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |