Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

TERMINATED

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

Lead Sponsor:

Abbott

Conditions:

Carcinoma, Non-Small-Cell Lung

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 st...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    March 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    25 Patients enrolled

    Trial Details

    Trial ID

    NCT00061646

    Start Date

    March 1 2003

    Last Update

    August 14 2007

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Oncology-Hematology Group of South Florida

    Miami, Florida, United States, 33176

    2

    University of Chicago

    Chicago, Illinois, United States, 60637-1470

    3

    The West Cancer Clinic

    Memphis, Tennessee, United States, 38120

    4

    University of Wisconsin

    Madison, Wisconsin, United States, 53792-5666