Patient Withdrawal Criteria

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Patients may withdraw from the study at any time for any reason, and without prejudice to further treatment.  In addition, patients can be withdrawn by the investigator if the investigator feels that the patient is not deriving clinical benefit or because of unacceptable toxicity.  Patients who are withdrawn or are removed from the study will be required to have an off-study clinic visit at the time of discontinuation, a 30-day follow-up safety visit, and will be followed for PFS and OS (reference schedule of assessments Section 20.1, Appendix A).

If a patient withdraws consent or is dropped from the study prematurely, the investigator must complete the appropriate case report form (CRF) and describe the reason for discontinuation.

Patients can be withdrawn from the study for any of the following medical, administrative, or regulatory reasons:

  • AE: If a patient suffers an AE, which in the judgment of the investigator, the Sponsor, or the Medical Monitor presents an unacceptable consequence or risk to the patient, the patient can be withdrawn from the study.
  • Administrative: After consultation, a patient can be withdrawn from the study for the following administrative reasons: 1) failure to complete the protocol-specified evaluations or 2) failure to comply with protocol requirements. Any administrative discontinuation must be documented on the appropriate CRF.
  • Withdrawal of Informed Consent: A patient can withdraw their consent to participate in the study at their own request or be withdrawn from participation in the study at the request of their legally authorized representative at any time for any reason.
  • Evidence of Progressive Disease: The Investigator can withdraw a patient from the study if there is a CT scan, MRI or other modality-confirmed progression of disease but continue to collect follow-up data for safety and overall survival as per protocol.

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