Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor. Presence of any severe or uncontrolled concurrent medical condition felt in the opinion of the investigator to increase the risk of serious toxicity from the study therapy Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator Any co-morbid medical condition that may put the patient at significant risk for toxicity Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements Significant organ compromise that will increase risk of toxicity or mortality Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements Unstable coronary artery disease or other medical condition (such as type 1 diabetes) that, in the Investigator's opinion, might increase the risk to the patient No serious medical illness that would potentially increase patients’ risk for toxicity Serious medical illness or severe debilitating pulmonary disease that would potentially increase the patients’ risk for toxicity Has a concomitant medical condition that would in the opinion of the Investigator increase the risk of toxicity. Serious medical illness that would potentially increase patients’ risk for toxicity Serious medical illness that would potentially increase patients’ risk for toxicity Any concurrent severe and/or uncontrolled medical conditions that could increase the patient’s risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicities Serious medical illness that would potentially increase patients’ risk for toxicity Presence of any co-morbid or an uncontrolled medical condition (e.g. diabetes mellitus), which in the opinion of the investigator would increase the potential risk to the subject. Investigator should liaise with the Medical Monitor where there is uncertainty as to the eligibility of a patient Serious medical illness that would potentially increase patients’ risk for toxicity Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements Concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor Any concurrent severe and/or uncontrolled medical conditions that could increase the patient’s risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicities Patient has an important medical illness or abnormal laboratory finding that, in the Investigator's opinion, would increase the risk of participating in this study. Concurrent medical condition which may increase the risk of toxicity, including:\r\n* Hypercalcemia of any cause\r\n* Untreated hyperparathyroidism\r\n* Paget’s disease of bone Any concurrent severe and/or uncontrolled medical conditions that could increase the patient’s risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicities Serious medical illness that would potentially increase patients’ risk for toxicity Presence of any severe or uncontrolled concurrent medical condition which, in the opinion of the investigator, would increase the risk of serious toxicity from the study drugs Serious medical illness that would potentially increase patients’ risk for toxicity Serious medical illness that would potentially increase patients’ risk for toxicity Presence of any severe or uncontrolled concurrent medical condition which, in the opinion of the investigator, would increase the risk of serious toxicity from the study drugs Any co-morbid disease that would increase risk of toxicity as determined by PI Serious medical illness that would potentially increase patients’ risk for toxicity Any medical condition that in the investigator’s opinion could interfere with interpretation of study or toxicity, or increase the risk to the patient related to potential toxicity Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor. Any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements A concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.