Sarcoma, Soft TissuePhase 2NCT00079950
Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma
A Phase 2 study testing Pegamotecan in people with Sarcoma, Soft Tissue, run by Enzon Pharmaceuticals, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Soft Tissue
- What is being tested?
- Pegamotecan
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Aug 2003to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Century City Hospital
Los Angeles, California, 90067
Pennsylvania Oncology Hematology Association
Philadelphia, Pennsylvania, 19106
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
Institute for Drug Development Cancer Therapy and Research Center
San Antonio, Texas, 78229
About this study
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.
- Conditions
- Sarcoma, Soft Tissue
- Being tested
- Pegamotecan
- Keywords
- soft, sarcoma, metastatic
- Medical subject headings
- Sarcoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegamotecanDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2004 (estimated)
- Study startAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma, Soft TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Enzon Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079950
- Sponsor's protocol ID
- CAM-9009
- Status last verified
- Sep 2012
- First submitted
- 18 Mar 2004
- Last updated
- 6 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT00079950
- Acronym / sponsor ID
- CAM-9009
- Conditions
- Sarcoma, Soft Tissue
- Keywords
- soft, sarcoma, metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Suspended
- Lead sponsor
- Enzon Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2003
- First posted
- 22 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegamotecan | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegamotecan in people with Sarcoma, Soft Tissue, run by Enzon Pharmaceuticals, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2012.