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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 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects with Locally Advanced or Metastatic Soft Tissue Sarcoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects with Locally Advanced or Metastatic Soft Tissue Sarcoma Clinical research trials and A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects with Locally Advanced or Metastatic Soft Tissue Sarcoma health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects with Locally Advanced or Metastatic Soft Tissue Sarcoma. A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects with Locally Advanced or Metastatic Soft Tissue Sarcoma Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects with Locally Advanced or Metastatic Soft Tissue Sarcoma clinical trial. Test subjects typically receive the most expert healthcare available for their A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects with Locally Advanced or Metastatic Soft Tissue Sarcoma condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects with Locally Advanced or Metastatic Soft Tissue Sarcoma  A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects with Locally Advanced or Metastatic Soft Tissue Sarcoma
A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects with Locally Advanced or Metastatic Soft Tissue Sarcoma
For Condition: Sarcoma, Soft Tissue
Status: Recruiting
Sponsor(s): Abbott Laboratories ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria A subject will be eligible for study participation if all of the following criteria are met: 1. The subject is at least 18 years of age. 2. 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. 3. The subject must have at least one lesion with measurable disease by RECIST criteria using CT or MRI. 4. The subject has received no more than two cytotoxic treatment regimens, not including adjuvant therapy for sarcoma. 5. The subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1. 6. The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous injections. 7. 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. 8. 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. 9. 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: 1. 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 2. The subjects is receiving therapeutic anticoagulation therapy. Low dose anticoagulation (e.g. low dose Coumadin) for catherter prophylaxis will be permitted; PT/PTT must be within normal limits. 3. The subject has a history of or currently exhibits clinically significant cancer related events of bleeding ( e.g. hemoptysis). The subject has a recent hisotry (within 4 weeks of Study Day 1) or currently exhibits other clinically significant signs of bleeding. 4. The subject has received any therapy for sarcoma including chemotherapy, radiotherapy or any investigational therapy inistration. 5. 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. 6. 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. 7. The subject’s life expectancy is less than 12 weeks.
Total Enrollment:
Location and Contact Information:
Arizona Cancer Center *Recruiting*
Tucson, Arizona, 85724
United States
Recruiting General Triage Line 480-657-1350
Virginia G. Piper Cancer Center *Recruiting*
Scottsdale, Arizona, 85724
United States
Recruiting General Triage Line 480-657-1350
Cancer Therapy and Research Center *Not yet recruiting*
San Antonio, Texas, 78229
United States
Not yet recruiting Eric Rowinski 210-616-5945
Center for Sarcoma and Bone Oncology Dana-Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Shay Newton 617-632-6708
University of Michigan *Recruiting*
Ann Arbor, Michigan, 48109-0948
United States
Recruiting Denise Reinke 734-936-4188
Additional Information:
Study ID Numbers: M02-534;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061659
Other Sarcoma, Soft Tissue Studies:
1. A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects with Locally Advanced or Metastatic Soft Tissue Sarcoma
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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
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