PD consists of greater than 25% increase in the sum of the perpendicular 
diameters of all measurable masses, or the appearance of new measurable 
lesions. 
1 1 .2.6 Mixed Response: 
Simultaneous progression and regression of measurable lesions or other 
indices of response will be called a mixed response and scored as disease 
progression (PD) for the purposes of this study. 
12.0 REMOVAL FROM STUDY 
12.1 Patients may withdraw or be removed from the study for any of the following reasons cited 
below. 
Criteria for Patient Removal: 
12.1.1 Patient's request to withdraw. 
12.1.2 Patient unwilling or unable to comply with study requirements. 
12.1.3 Clinical need for concomitant or ancillary therapy not permitted in the study. 
12.1.4 Any unacceptable treatment-related toxicity precluding further participation in the 
study. 
12.1.5 Unrelated intercurrent illness which, in the judgment of the principal 
investigator, will affect assessments of clinical status to a significant degree. 
12.2 A patient removed from the study prior to any of the scheduled response evaluations will be 
considered inevaluable for response. 
13.0 CONCOMITANT OR ANCILLARY THERAPY 
13.1 Concomitant Medications 
13.1.1 Padents may be premedicated prior to ACN53 administradon at the investigator's 
discretion with acetaminophen, diphenhydramine, and/or benzodiazepines. 
Corticosteroids are not to be given for routine premedication. 
13.1.2 Any specific antitumor treatment including cytotoxic chemotherapy, hormonal 
therapy, biological therapy, radiation therapy, and oncologic surgery must not be 
administered or performed while the patient is actively on study (from Study 
Admission to the time of Post-Study Evaluation; see Section 7.6). 
13.1.3 Patients must not receive any other investigational drugs while actively on study 
(from Study Admission to the time of Post-Study Evaluation; see Section 7.6). 
13.2 Patients will receive full supportive care including transfusions of blood and blood 
products, intravenous fluids, antibiotics, antiemetics, analgesics, antipyretics, etc., when 
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