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Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects With Non-Small Cell Lung Cancer (NSCLC)

This study has been terminated.
(Enrollment suspended based upon interim analysis; subjects allowed to stay on study until disease progression.)
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00061646
First received: June 2, 2003
Last updated: August 10, 2007
Last verified: August 2007
June 2, 2003
August 10, 2007
March 2003
Not Provided
Progression free survival [ Time Frame: One year ]
Not Provided
Complete list of historical versions of study NCT00061646 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: One year ]
  • Response rate [ Time Frame: One year ]
Not Provided
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Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects With Non-Small Cell Lung Cancer (NSCLC)
A Phase II Single-Arm Study Evaluating the Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects With Non-Small Cell Lung Cancer (NSCLC)
The primary objective of this Phase II study is to assess the safety, pharmacokinetics and effectiveness of ABT-510 in combination with standard carboplatin/paclitaxel chemotherapy in subjects with stage IIIb or IV NSCLC.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: ABT-510/Thrombospondin-1 mimetic
  • Drug: Carboplatin/Taxol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
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Inclusion Criteria

  • The subject is at least 18 years of age.
  • The subject has histologically or cytology documented Stage IIIB with pleural effusion or Stage IV NSCLC. The subject must have measurable disease (RECIST Criteria for Tumor Response).
  • The subject has not received first line therapy for treatment of NSCLC.
  • 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 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 SC injections.
  • The subject must have adequate bone marrow, renal and hepatic function as follows:

    • Bone marrow: White blood cell count (WBC) >= 3,000/mm3; Platelets; >= 100,000/mm3; Hemoglobin >= 9.0 g/dL;
    • Renal function: Serum creatinine <= 2.0 mg/dL;
    • Hepatic function: Bilirubin <= 1.5 mg/dL; AST and ALT <= 1.5 X the upper normal limit (ULN); unless liver metastases are present, then AST and ALT <= 5.0 x ULN.
  • 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 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 subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation 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 of (within 4 weeks from Study Day 1) or currently exhibits other clinically significant events of bleeding.
  • The subject has received investigational therapy within four weeks prior to study drug 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 has previous or current malignancies at other sites, with the exception of: Adequately treated in situ carcinoma of the cervix uteri; Basal or squamous cell carcinoma of the skin; Previous nonpulmonary malignancy confined and surgically resected with no evidence of active malignancy.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00061646
M02-429
No
Not Provided
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Abbott
Not Provided
Study Director: Global Medical Information 1-800-633-9110 Abbott
Abbott
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP