Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
