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

Primary Purpose

Sarcoma, Soft Tissue

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-510 - Thrombospondin-1 mimetic
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Soft Tissue focused on measuring high grade locally advanced/metastatic soft tissue sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Virginia G. Piper Cancer Center
  • Arizona Cancer Center
  • Center for Sarcoma and Bone Oncology Dana-Farber Cancer Institute
  • University of Michigan
  • Cancer Therapy and Research Center

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Response rate
Overall survival
Performance status

Full Information

First Posted
June 2, 2003
Last Updated
November 28, 2007
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00061659
Brief Title
Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Soft Tissue
Keywords
high grade locally advanced/metastatic soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ABT-510 - Thrombospondin-1 mimetic
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
One year
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
One year
Title
Overall survival
Time Frame
One year
Title
Performance status
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rod Humerickhouse, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Virginia G. Piper Cancer Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Center for Sarcoma and Bone Oncology Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0948
Country
United States
Facility Name
Cancer Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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