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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)

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

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)

Inclusion Criteria

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

- 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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

One year

Principal Investigator

Global Medical Information 1-800-633-9110

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Stage IIIb with pleural effusion or IV NSCLC
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Oncology-Hematology Group of South Florida Miami, Florida  33176
University of Chicago Chicago, Illinois  60637
The West Cancer Clinic Memphis, Tennessee  38120
University of Wisconsin Madison,, Wisconsin  53792-5666