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

NCT ID: NCT00061659

Last Updated: 2007-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2006-04-30

Brief 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.

Conditions

Sarcoma, Soft Tissue

Keywords

high grade locally advanced/metastatic soft tissue sarcoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ABT-510 - Thrombospondin-1 mimetic

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.
• 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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Principal Investigators

Rod Humerickhouse, MD

Role: STUDY_DIRECTOR

Abbott

Locations

Virginia G. Piper Cancer Center

Scottsdale, Arizona, United States

Arizona Cancer Center

Tucson, Arizona, United States

Center for Sarcoma and Bone Oncology Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Cancer Therapy and Research Center

San Antonio, Texas, United States

Countries

United States

Other Identifiers

M02-534

Identifier Type: -

Identifier Source: org_study_id