PHASE I STUDY OF PALBOCICLIB ALONE AND IN COMBINATION IN PATIENTS WITH RELAPSED AND REFRACTORY LEUKEMIAS
If you are reading and signing this form on behalf of a potential participant, please note: Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn more about the safety and effects of palbociclib, when given alone and then in combination with different standard drugs to patients with leukemia that is relapsed (has come back) or refractory (has not responded to treatment). The standard drugs being used are sorafenib, decitabine, and dexamethasone. Different doses of the standard drugs will be tested. Researchers will also be performing research tests, such as biomarker, pharmacodynamic (PD), and cytogenetic testing. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug. The biomarker testing in this study will include genetic biomarker testing. PD testing measures how the level of study drug in your body may affect the disease. Cytogenetic testing looks at how genetic changes to cells may affect how the disease may react to the study drug.
Disease Group: Malignant neoplasms stated as primary lymphoid haematopoietic
Treatment Agent: Decitabine,Dexamethasone,Palbociclib,Sorafenib
Treatment Location: Only at MDACC
Sponsor: IND Office,Pfizer, Inc.
IRB Review and Approval Date: 07/25/2017
Recruitment Status: Open
Projected Accrual: N/A
Information and next steps
Malignant neoplasms stated as primary lymphoid haematopoietic
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