NCT00079950SuspendedPhase 2
Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Suspended
- Sponsor
- Enzon Pharmaceuticals, Inc.
- Locations
- 8
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Pegamotecan (Peg-Camptothecin) in patients with Advanced or Metastatic Soft Tissue sarcoma.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically or cytologically confirmed diagnosis of soft tissue sarcoma with measurable disease.
- •Target tumors outside prior radiation field(s).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil count.
- •Adequate renal function
- •Adequate liver function
- •No history of hemorrhagic cystitis or evidence of microscopic hematuria
- •Capable of understanding the protocol requirements and risks and providing written informed consent.
- •Either 0 or 1 prior chemotherapy regimens
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).
Investigators
Study Sites (8)
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