Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT01325558
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed
* Locally advanced or metastatic non-hematologic malignancies
* Measureable
* Refractory to standard therapies or single agent gemcitabine is indicated as a standard treatment option
PRIOR/CONCURRENT THERAPY:
* No concurrent radiotherapy, chemotherapy, immunotherapy or other investigational agents
* Must have recovered from side effects of prior therapies
PATIENT CHARACTERISTICS:
Life expectancy
* \> 12 weeks
Performance Status
* ECOG 0 or 1
Bone Marrow Reserve
* Absolute Neutrophil count (AGC/ANC) ≥ 1,500/uL
* Platelets ≥ 100,000/uL
* Hemoglobin \> 9 g/dL
Renal Function
* Calculated Glomerular filtration rate (GFR) \> 59mL/min/1.73M\^2
Hepatic Function
* Total bilirubin ≤ 1.5 X ULN
* AST, ALT, and ALP ≤ 3 X ULN or ≤ 5.0 x ULN, if liver metastasis exists
* PT INR ≤ 1.5 X ULN
Cardiovascular
* No history of clinically significant vascular disease
* No New York Heart Association (NYHA) Class \> II heart failure
Hematologic
* No history of bleeding disorders
* No evidence of bleeding diathesis or coagulopathy
* No presence of clinically significant hemoptysis or hematuria, presence of serious non-healing wound or ulceration, or signs of other bleeding
* No evidence of a tumor invasion of any major blood vessel
* No trauma with increased risk of life-threatening bleeding or history of severe head trauma or intracranial surgery within two months of study entry
Surgery/Procedures
* No major surgery or open biopsy within 28 days before drug infusion or evidence of active bleeding postoperatively
* No plan for any major surgery during treatment period
* No presence or requirement of an epidural catheter or lumbar puncture within 48 hours prior to each dose of study treatment
* No anticipation of receiving an epidural catheter or a lumbar puncture within 48 hours after each dose of study treatment
Excluded Medications or Treatment Regimens
* Unfractionated heparin of \> 15,000 units/day within 8 hours prior to each dose of study treatment
* Low-molecular weight heparin at a higher dose than recommended for prophylactic used or required within 20 hours prior to each dose of study treatment
* Warfarin used or required within 48 hours prior to each dose of study treatment and the prothrombin time (INR) exceeded the upper limit of normal range
* Direct thrombin inhibitors or Xa inhibitors
* Acetylsalicylic acid used or required within 72 hours prior to each dose of study treatment
* Clopidogrel bisulfate used or required within 48 hours prior to each dose of study treatment
* Anticipated requirement for anti-platelet or anti-coagulant agents excluding non-aspirin NSAID within 48 hours following study treatment infusion
Other
* No active systemic infection requiring parenteral antibiotic therapy
* No history of or presence of a CNS disease
* No history of allergic reactions to compounds of similar chemical or biologic composition
* Not HIV positive
* No women who are pregnant or nursing
* A negative serum pregnancy test if female
* Patients, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study
* No history of significant renal, endocrinologic, metabolic, immunologic or hepatic disease
* No evidence of psychiatric illness/social situations
* Other illness that in the opinion of the investigator would exclude the patient from participating
* Must provide informed consent and HIPAA authorization and comply with protocol-specified procedures and follow-up evaluations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01325558
Study Brief:
Protocol Section:
NCT01325558