Last Update Posted : May 16, Study Description. Detailed Description:. MedlinePlus related topics: Melanoma. Drug Information available for: Vemurafenib. FDA Resources.
Arms and Interventions. Outcome Measures. Eligibility Criteria. Patients must have disease sites amenable to biopsy. Prior biologic therapy and localized radiation therapy must have been completed a minimum of 2 weeks prior to starting therapy. Patients with a history of CNS metastasis, who have been treated prior to enrollment, must be stable for eight weeks after completion of treatment.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. Federal Government. Read our disclaimer for details. Last Update Posted : May 16, Study Description. Detailed Description:. Drug Information available for: Docetaxel. FDA Resources. Arms and Interventions. Oral PX administered daily at the RD in combination with IV docetaxel administered once every three weeks on a 21 day cycle. IV docetaxel administered once every three weeks as per standard of care. Oral PX, administered daily at the RD in combination with IV docetaxel administered once every three weeks on a 21 day cycle.
Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Phase I Trial of Oral PX The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : May 17, Study Description.
This study is being conducted to determine the safety and maximally tolerated dose of PX when given orally on two different schedules: daily on days and of a 28 day cycle and daily on days of a 28 day cycle. Detailed Description:. PX is a targeted inhibitor of PI-3K. This study is being conducted to determine the maximally tolerated dose of PX when given orally on two different schedules: daily on days and of a 28 day cycle and daily on days of a 28 day cycle.
Arms and Interventions. Oral solution, dose escalation, once per day on days 1 to 5 and 8 to 12 or days of a 28 day cycle, until progression or development of unacceptable toxicity. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. A minimum of 28 days since the last dose of chemotherapy must have elapsed prior to registration.
No prior therapy with a phosphatidylinositol 3-kinase PI-3K inhibitor. Other targeted agents are permissible provided they were given as part of front line treatment. A minimum of 56 days 8 weeks must have elapsed since last day for anti-angiogenic therapy and minimum of 28 days for other targeted agents. Patients may have had prior radiation therapy provided at least 28 days have elapsed from the day of the last fraction of radiation to the date of registration.
The idea behind this is to restrict entry to a subset of patients who are not rapidly changing: especially rapidly deteriorating. If a patient being worked up for the trial appears to need to have steroid introduced or increased, the patient should be treated as is medically appropriate i. Steroid should NOT be withheld if clinically indicated just so that patients can be registered on study!
Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U.
Federal Government. Read our disclaimer for details.
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