Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma

Exclusion Criteria

• •Subject has a diagnosis of gastrointestinal stromal tumors.
• •Concurrent serious medical illness unrelated to tumor within the past 6 months.
• •Known chronic infectious disease, such as AIDS or hepatitis.
• •Positive screening pregnancy test or is breast-feeding.
• •A female or male subject of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this study.
• •Receiving concurrent chemotherapy, radiotherapy, or surgery, or has received wide field radiation within the previous 4 weeks.
• •History of another active malignancy (except non-melanoma skin cancer and carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for the last 2 years.
• •Known or clinically suspected brain metastases.
• •Received more than one prior treatment regimen (excluding adjuvant or neoadjuvant therapy) for soft tissue sarcoma.
• •Received any investigational drug within the last 30 days.
• •Not fully recovered from any prior surgery (at least 4 weeks recovery period for major surgery), and from any reversible side effects related to the administration of cytotoxic chemotherapy or radiation therapy.
• •Received a prior camptothecin analog (e.g., topotecan, irinotecan).