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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The goal of this study is to determine whether a significant pharmacokinetic interaction exists between rapamycin and sorafenib.
This study will also look at the toxicity of the combination of rapamycin and sorafenib and the antitumor activity of the combination in subjects with advanced cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Sorafenib two times a day every day for 28 days. Beginning on Day 15 (Week 2), rapamycin will be taken once a week until the end of the cycle (Day 28). After Day 28, weekly rapamycin and daily sorafenib will continue until disease progression or serious side effects are experienced. |
|
| B | Experimental | Sorafenib two times a day every day for 28 days. Beginning on Day 15 (Week 2), rapamycin will be taken every day until the end of the cycle (Day 28). After Day 28, rapamycin and sorafenib can continue to be taken daily until the cancer gets worse or serious side effects are experienced. |
|
| C | Experimental | Rapamycin once a week starting on Day 1. Beginning on Day 15 (Week 2), sorafenib will be taken twice a day every day until the end of the cycle (Day 28). After Day 28, weekly rapamycin and daily sorafenib will continue until disease progression or serious side effects are experienced. |
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| D | Experimental | Rapamycin every day beginning on Day 1. Starting on Day 15 (Week 2), sorafenib will be taken twice a day every day until the end of the cycle (Day 28). After Day 28, rapamycin and sorafenib can continue to be taken daily until the cancer gets worse or serious side effects are experienced. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib | Drug | 400mg BID (200 mg twice daily) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic interactions | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | 8 weeks |
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Inclusion Criteria:
Solid cancer for which curative measures have failed or for which there is no known superior treatment
ECOG performance status 0-2
Measurable or non-measurable disease
Life expectancy of greater than 12 weeks and no anticipated need for other antineoplastic therapy in the next 4 weeks
Age 18 years or older
Patients must have adequate organ and marrow function as defined below:
Women of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment.
Ability to understand and the willingness to sign a written informed consent document
Must not have any evidence of bleeding diathesis.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ezra Cohen, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Rapamycin | Drug | 30mg once weekly |
|
|
| Rapamycin | Drug | 3mg once daily |
|
|
| 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 |
| D018942 | Macrolides |
| D007783 | Lactones |