Suspended

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Neoplasms+1

+ Neoplasms by Histologic Type

+ Sarcoma

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2003
See protocol details

Summary

Principal SponsorEnzon Pharmaceuticals, Inc.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleEfficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma 
NCT00079950
Principal SponsorEnzon Pharmaceuticals, Inc.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeSarcomaNeoplasms, Connective and Soft Tissue

Criteria

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 0-2. * 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).

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Century City Hospital

Los Angeles, United StatesSee the location
Suspended

Pennsylvania Oncology Hematology Association

Philadelphia, United States
Suspended

University of Pittsburgh Cancer Institute

Pittsburgh, United States
Suspended

Institute for Drug Development Cancer Therapy and Research Center

San Antonio, United States
Suspended4 Study Centers