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Sarcoma, Soft TissuePhase 2NCT00061659

Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma

A Phase 2 study testing ABT-510 - Thrombospondin-1 mimetic in people with Sarcoma, Soft Tissue, run by Abbott at 5 sites in United States.

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 primary objective of this study is to assess the safety and effectiveness of ABT-510 in subjects with locally 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?
ABT-510 - Thrombospondin-1 mimetic
How many people
88 participants
Where
5 sitesUnited States
Study dates
May 2003to Apr 2006
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

  • A subject will be eligible for study participation if all of the following criteria are met:
  • The subject is at least 18 years of age.
  • The subject has histologically confirmed high grade locally advanced or metastatic soft tissue sarcoma (excluding Ewings sarcoma and chondrosarcoma) not amenable to surgery, radiotherapy or combined modality therapy with curative intent.
  • The subject must have at least one lesion with measurable disease by RECIST criteria using CT or MRI.
  • The subject has received no more than two cytotoxic treatment regimens, not including adjuvant therapy for sarcoma.
  • The subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
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  • The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous injections.
  • The subject must have adequate bone marrow, renal and hepatic function as follows:
  • Bone marrow: White blood cell count (WBC) greater than or equal to 3,000/mm3; Platelets; greater than or equal to 100,000/mm3; Hemoglobin greater than or equal to 9.0 g/dL;
  • Renal function: Serum creatinine less than or equal to 2.0 mg/dL;
  • Hepatic function: Bilirubin less than or equal to 1.5 mg/dL; AST and ALT less than or equal to 1.5 X the upper normal limit (ULN) unless liver metastases are present, then AST and ALT less than or equal to 5.0 x ULN.
  • The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed acceptable by the investigator while in the study and for up to two months following completion of therapy.
  • The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures.

Who cannot join

  • A subject will be ineligible for study participation if any of the following criteria are met:
  • The subject has a history of or currently exhibits Central Nervous System (CNS) metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of CNS metastases
  • The subjects is receiving therapeutic anticoagulation therapy. Low dose anticoagulation (e.g. low dose Coumadin) for catheter prophylaxis will be permitted; PT/PTT must be within normal limits.
  • The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g. hemoptysis). The subject has a recent history (within 4 weeks of Study Day 1) or currently exhibits other clinically significant signs of bleeding.
  • The subject has received any therapy for sarcoma including chemotherapy, radiotherapy or any investigational therapy.
  • The subject exhibits evidence of clinically significant uncontrolled condition(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures.
  • The subject has history of other previous malignancies within five years, with the exception of:Adequately treated in situ carcinoma of the cervix uteri; Basal or squamous cell carcinoma of the skin.
  • The subject's life expectancy is less than 12 weeks.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109-0948

  • Center for Sarcoma and Bone Oncology Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Cancer Therapy and Research Center

    San Antonio, Texas, 78229

  • Virginia G. Piper Cancer Center

    Scottsdale, Arizona, 85724

  • Arizona Cancer Center

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma

The primary objective of this study is to assess the safety and effectiveness of ABT-510 in subjects with locally advanced or metastatic soft tissue sarcoma.

Being tested
ABT-510 - Thrombospondin-1 mimetic
Keywords
high grade locally advanced/metastatic soft tissue sarcoma
Medical subject headings
Sarcoma

What participants receive

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

  • ABT-510 - Thrombospondin-1 mimeticDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Measured: One year

Secondary outcomes (3)

  1. Response rate

    Measured: One year

  2. Overall survival

    Measured: One year

  3. Performance status

    Measured: One year

Timeline

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

  1. First posted4 Jun 2003 (estimated)
  2. Study startMay 2003
  3. Study completionApr 2006

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00061659
Sponsor's protocol ID
M02-534
Status last verified
Nov 2007
First submitted
2 Jun 2003
Last updated
29 Nov 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-510 - Thrombospondin-1 mimetic in people with Sarcoma, Soft Tissue, run by Abbott at 5 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 13 inclusion and 8 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 29 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

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.

What does the primary outcome measure?

Progression free survival (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00061659.

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 29 Nov 2007.

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