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This is a pilot study of sorafenib in patients with BRAF Mutation Refractory Solid Tumors.
This study is a single-arm, pilot study of sorafenib in patients with Refractory Solid Tumors harboring BRAF Mutation Sorafenib 400 mg will be administered orally twice a day for 28 days.
To investigate the efficacy of sorafenib in patients with Refractory Solid Tumors harboring BRAF Mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib | Experimental | Sorafenib 400 mg will be administered orally twice a day for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sorafenib | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | expected average of 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | expected average of 24 weeks | |
| Time to progression | expected average of 24 weeks | |
| overall survival |
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Inclusion Criteria:
Provision of fully informed consent prior to any study specific procedures.
Patients must be ≥20 years of age.
BRAF mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
ECOG performance status 0-2.
Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
Adequate Organ Function Laboratory Values
Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
Adequate heart function.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Seoul, Korea, Republic of | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| expected average of 24 weeks |
| Number of subjects with Adverse Events as a measure of toxicity profile | expected average of 24 weeks |
| 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 |