Criteria for Removal from Treatment Sample Clauses

Criteria for Removal from Treatment. The criteria for enrollment must be followed explicitly. If a patient who does not meet enrollment criteria is inadvertently enrolled, Lixte Biotechnology Holdings, Inc must be contacted. In these cases, the investigator must obtain documented approval Jxxx Xxxxxx, M.D. President and CEO of Lixte Biotechnology Holdings, Inc to allow the patient to continue to receive the study drug. Dx. Xxxxxx’x contact information is: telephone 600-000-0000 and email jxxxxxx@xxxxx.xxx. In addition, patients will be discontinued from the study drug and from the study in the following circumstances: ● Enrollment in any other clinical trial involving an investigational product or enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study. ● Investigator/Physician Decision o The investigator/physician decides that the patient should be withdraw from the study or study drug. o If the patient, for any reason, requires treatment with another therapeutic agent that has been demonstrated to be effective for treatment of the study indication, discontinuation from the study drug occurs prior to introduction of the new agent. ● Patient Decision o The patient [or patient’s designee (for example, parents or legal guardian)] requests to be withdrawn from the study or study drug. ● Sponsor Decision o The investigator or DSMB or Sponsor stops the study or stops the patient’s participation in the study for medical, safety, regulatory, or other reasons consistent with applicable laws, regulations, and good clinical practice. ● The patient is significantly noncompliant with study procedures and/or treatment ● The patient has evidence of disease progression ● Unacceptable toxicity ● The patient becomes pregnant or fails to use adequate birth control (for those patients who are of childbearing potential). The reason and date for discontinuation will be collected for all patients. All randomized patients who discontinue regardless of whether they received study drug or not, will have procedures performed as shown in the Study Schedule (Section 10.0).
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Related to Criteria for Removal from Treatment

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