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This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore EMD 1214063, in patients with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available.
Subjects will be assigned to one of two dosing regimens:
- Regimen 1: EMD 1214063 every day for 14 days, followed by seven days with no treatment (21-day cycle)
- Regimen 2: EMD 1214063 three times per week (e.g., Days 1, 3, and 5) for three weeks (21-day cycle)
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Patients With Solid Tumors, Either Refractory to Standard Therapy or for Which no Effective Standard Therapy is Available
EMD 1214063, EMD 1214063
M.D. Anderson Cancer Center
Published on BioPortfolio: 2014-08-27T03:17:56-0400
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The characteristics and management of invasive pulmonary aspergillosis (IPA) in patients with hematologic malignancies are well known, but IPA in patients with solid tumors is not well described.
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An internationally recognized set of published rules used for evaluation of cancer treatment that define when tumors found in cancer patients improve, worsen, or remain stable during treatment. These criteria are based specifically on the response of the tumor(s) to treatment, and not on the overall health status of the patient resulting from treatment.
Chronic refractory anemia with granulocytopenia, and/or thrombocytopenia. Myeloblasts and progranulocytes constitute 5 to 40 percent of the nucleated marrow cells.
An alkylating agent of value against both hematologic malignancies and solid tumors.
Procedures using an electrically heated wire or scalpel to treat hemorrhage (e.g., bleeding ulcers) and to ablate tumors, mucosal lesions, and refractory arrhythmias. It is different from ELECTROSURGERY which is used more for cutting tissue than destroying and in which the patient is part of the electric circuit.
The period of time following the triggering of an ACTION POTENTIAL when the CELL MEMBRANE has changed to an unexcitable state and is gradually restored to the resting (excitable) state. During the absolute refractory period no other stimulus can trigger a response. This is followed by the relative refractory period during which the cell gradually becomes more excitable and the stronger impulse that is required to illicit a response gradually lessens to that required during the resting state.
Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers) - Mouth cancer can develop on the lip, the tongue, the floor...