Osi-906 clinical trial
Pregnant or breast-feeding females. Symptomatic brain metastases that are not stable, require steroids, are potentially life threatening, or that have required radiation within 28 days prior to randomization. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drug. 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. More Information. Linsitinib OSI versus placebo for patients with locally advanced or metastatic adrenocortical carcinoma: a double-blind, randomised, phase 3 study. Lancet Oncol. Epub Mar National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Adrenocortical Carcinoma. Phase 3. Study Type :. Interventional Clinical Trial. Detailed Description:. Drug Information available for: Erlotinib hydrochloride Erlotinib. FDA Resources. Arms and Interventions. Tablet administered with food and with up to mL of water.
Tablet administered at least 2 hours after food with up to mL of water. Outcome Measures. Eligibility Criteria.
Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. EGFR analysis can be performed either by central or local laboratory. If analysis is done locally, verifiable documentation confirming the EGFR mutation status must be submitted for review and approval by APGD prior to randomization.
If no local result is available, formalin-fixed, paraffin-embedded archival tissue representative of the tumor or in the absence of archival tissue, a fresh tumor tissue sample of sufficient size to perform EGFR mutation analysis must be submitted centrally. Results of the central analysis must be available prior to randomization.
Acceptable forms include:. 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.
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Last Update Posted : January 24, Study Description. Detailed Description:. MedlinePlus related topics: Genes and Gene Therapy. Drug Information available for: Urogastrone Erlotinib hydrochloride Erlotinib. FDA Resources. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Women of childbearing potential must provide a negative pregnancy test serum or urine within 14 days prior to randomization Patients must provide written informed consent to participate in the study Prior radiation therapy is permitted provided patients have recovered from the acute, toxic effects of radiotherapy prior to randomization. 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. More Information. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
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