A phase II randomized study evaluating the safety and efficacy of ABT-510 in subjects with locally advanced or metastatic soft tissue sarcoma

Journal of Drugs in Dermatology, August, 2003

Sponsored by: Abbott Laboratories

Purpose: 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.

Condition              Treatment or Intervention    Phase

Sarcoma, Soft Tissue   Drug: ABT-510--
                         Thrombospondin-1 mimetic   Phase II

Study Type: Interventional

Study Design: Treatment

Ages eligible for study: 18 years and above, both genders

Inclusion Criteria:

* The subject is at least 18 years of age.

* The subject has histologically confirmed high grade locally advanced or metastatic soft tissue sarcoma (excluding Ewing's 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/[mm.sup.3]; * Platelets; greater than or equal to 100,000/[mm.sup.3]; * 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:

* The subject has known Central Nervous System (CNS) metastasis. Brain CT or MRI within 28 days of enrollment is required to confirm absence of CNS metastases. Subjects with previously treated brain metastases are eligible if no evidence of disease is observed on CT.

* The subject has received any therapy for sarcoma including chemotherapy, radiotherapy or any investigational therapy administration.

* 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 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.

* 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.

Location and Contact Information

Ray Knight, BS MBA Tel: 847-938-1378 E-mail: raymond.knight@abbott.com

Michigan

Study ID Numbers M02-534

NLM Identifier NCT00061659