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Soft Tissue SarcomaPhase 2NCT00087997

A Study of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Soft Tissue Sarcomas

A Phase 2 study testing STA-4783 in people with Soft Tissue Sarcoma, run by Synta Pharmaceuticals Corp. at 27 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and effectiveness of an experimental study drug (STA-4783) combined with an approved cancer medicine, paclitaxel, in the treatment of soft tissue sarcomas. Paclitaxel (Taxol®) has been approved and used in the United States since 1992. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
STA-4783
How many people
80 participants
Where
27 sitesin 2 countries
Study dates
Jul 2004to Oct 2005
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

  • Must be 18 years of age or older with histologic diagnosis of soft tissue sarcoma
  • Must have disease not suitable for curative resection
  • Must have failed >1 first line treatment with evidence of progression. Adjuvant therapy does not count as 1st line therapy unless recurrence occurs within 6 months of administration
  • Must have ability to understand and the willingness to sign a written informed consent document
  • Must have Eastern Cooperative Oncology Group (ECOG) performance status of < 2
  • Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
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  • At least 4 weeks have passed since the last chemotherapy, immunotherapy, or radiation therapy
  • There must be measurable disease outside the radiotherapy fields or progression of the indicator lesions within the field since the completion of the radiotherapy
  • Must have a life expectancy of greater than 12 weeks
  • Must have clinical laboratory values at screening as defined below:
  • Hemoglobin >9 g/dL,
  • Absolute neutrophil count >1500/mm3,
  • Platelet count >100,000/mm3,
  • Creatinine <1.5 X ULN,
  • Bilirubin <1.5 X ULN,
  • Asparate aminotransferase and alanine aminotransferase <2.5 X ULN (<5 X ULN in presence of liver metastases)

Who cannot join

  • Female patients who are pregnant or breast feeding
  • Patients of childbearing potential not using or not willing to use a barrier method of contraception
  • Prior malignancy other than soft tissue sarcoma (STS) within the last 5 yrs with the exception of:
  • Adequately treated in situ carcinoma of the cervix uteri;
  • Basal or squamous cell carcinoma of the skin
  • Presence of a clinically significant and uncontrolled infection
Show all 14Show fewer
  • Presence of >Grade 2 neuropathy
  • Symptomatic central nervous system metastases within last 8 weeks or on corticosteroids for CNS symptom management
  • Presence of clinically significant arrythmias
  • Presence of a serious concurrent illness or other conditions (e.g., psychological, family, sociological, or geographical circumstances) that do not permit adequate follow-up and compliance with the protocol
  • History of severe hypersensitivity reactions to taxanes or cremaphore in spite of premedication
  • Use of any investigational agents within 4 weeks prior to the first dose of study drug(s)
  • Major surgery within 2 weeks of screening
  • Radiation treatment in past >25% of bone marrow

Trial locations and contacts

27 sites in 2 countries.

27 sites in 2 countries

United States26 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Carolinas Medical Center/Blumenthal Cancer Center

    Charlotte, North Carolina, 28203

  • University of Chicago Department of Medicine

    Chicago, Illinois, 60637

  • Wayne State University

    Detroit, Michigan, 48201

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • University of Florida

    Gainesville, Florida, 32610

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • UCLA

    Los Angeles, California, 90095

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

  • The West Clinic

    Memphis, Tennessee, 38120

  • The Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • NYU Cancer Institute Clinical Center

    New York, New York, 10016

  • Herbert Irving Cancer Center

    New York, New York, 10032

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Arizona Cancer Center

    Scottsdale, Arizona, 85258

  • Feist-Weiller Cancer Center

    Shreveport, Louisiana, 71103

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

  • Via Christi Regional Med. Center (Wichita CCOP)

    Wichita, Kansas, 67214

Other trials in United States

Canada1 site

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

Other trials in Canada

About this study

The purpose of this study is to evaluate the safety and effectiveness of an experimental study drug (STA-4783) combined with an approved cancer medicine, paclitaxel, in the treatment of soft tissue sarcomas. Paclitaxel (Taxol®) has been approved and used in the United States since 1992.

Read the detailed description

STA-4783 is a taxane potentiator, enhancing the effect of antitumor response of paclitaxel. In an attempt to improve efficacy, paclitaxel is sometimes used in combination with other anticancer agents. When paclitaxel is combined with other anticancer agents, although response rate is usually increased, side effects are usually increased as well. There is an urgent need for agents that can enhance the antitumor effects of paclitaxel without further increasing undesirable side effects.

Being tested
STA-4783
Keywords
sarcoma
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STA-4783Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2004 (estimated)
  2. Study startJul 2004
  3. Study completionOct 2005

Resources

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)
Enrolment
80 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00087997
Sponsor's protocol ID
4783-04
Status last verified
Jun 2006
First submitted
19 Jul 2004
Last updated
20 Jun 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing STA-4783 in people with Soft Tissue Sarcoma, run by Synta Pharmaceuticals Corp. at 27 sites in 2 countries.

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 16 inclusion and 14 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: finished, as of the sponsor's last update on 20 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

On the ClinicalTrials.gov record for NCT00087997.

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 20 Jun 2006.

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