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


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma, Soft Tissue

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

One year

Principal Investigator

Rod Humerickhouse, MD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

M02-534

NCT ID:

NCT00061659

Start Date:

May 2003

Completion Date:

April 2006

Related Keywords:

  • Sarcoma, Soft Tissue
  • high grade locally advanced/metastatic soft tissue sarcoma
  • Sarcoma

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of MichiganAnn Arbor, Michigan  48109-0624
Cancer Therapy and Research CenterSan Antonio, Texas  78229
Virginia G. Piper Cancer CenterScottsdale, Arizona  85724
Center for Sarcoma and Bone Oncology Dana-Farber Cancer InstituteBoston, Massachusetts  02115