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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
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
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
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00061646
M02-429
No
Not Provided
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