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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00061646
Recruitment Status : Terminated (Enrollment suspended based upon interim analysis; subjects allowed to stay on study until disease progression.)
First Posted : June 4, 2003
Last Update Posted : August 14, 2007
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE June 2, 2003
First Posted Date  ICMJE June 4, 2003
Last Update Posted Date August 14, 2007
Study Start Date  ICMJE March 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2007)
Progression free survival [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00061646 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2007)
  • Overall survival [ Time Frame: One year ]
  • Response rate [ Time Frame: One year ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects With Non-Small Cell Lung Cancer (NSCLC)
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: ABT-510/Thrombospondin-1 mimetic
  • Drug: Carboplatin/Taxol
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 10, 2007)
25
Original Enrollment  ICMJE Not Provided
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00061646
Other Study ID Numbers  ICMJE M02-429
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Medical Information 1-800-633-9110 Abbott
PRS Account Abbott
Verification Date August 2007

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