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:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT01279603
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed solid tumors or lymphomas
* Tumor progression observed after receiving standard/approved systemic chemotherapy and/or immunotherapy including monoclonal antibodies, or when there is no approved or effective therapy
* One or more measureable tumors by radiological evaluation
* Karnofsky performance ≥ 70%
* Life expectancy of ≥ 3 months
* Age ≥ 18 years
* Signed, written IRB-approved informed consent
* Negative pregnancy test (if female)
* Adequate liver function:
* Bilirubin less than or equal to 1.5 x upper limit of normal (ULN)
* AST (SGOT), ALT (SGPT) and Alkaline phosphatase less than or equal to 2.5 x ULN (if liver metastases are present, then less than or equal to 5 x ULN is allowed)
* Adequate renal function:
* Serum creatinine within normal limits, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine above institutional ULN.
* Corrected serum calcium ≥ lower limit of the institutional normal range (LLN)
* Serum phosphorus level ≥ LLN
* Adequate hematologic function:
* Absolute Neutrophil Count ≥ 1500 cells/mm3
* Platelet count ≥ 100,000 (cells/mm3)
* Hemoglobin ≥ 9 g/dL
* Urinalysis:
* No clinically significant abnormalities
* Adequate coagulation function:
* PT ≤ 1.25 x ULN
* PTT ≤ 1.25 x ULN
* For men and women of child-producing potential, agreement to use effective contraceptive methods during the study
Exclusion Criteria:
* New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
* Pregnant or nursing women. NOTE: Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.
* Major surgery within 4 weeks prior to Day 1, or not fully recovered by Day 1
* Minor surgery within 2 weeks prior to Day 1, or not fully recovered by Day 1
* Treatment with radiation therapy within 4 weeks prior to Day 1.
* Received systemic chemotherapy or monoclonal antibody or other immunotherapy within 4 weeks prior to Day 1 (exceptions: 6 weeks for nitrosourea, mitomycin C, or any agent with a known treatment effect \> 4 weeks' duration), or not fully recovered from any side effects from previous therapy by Day 1
* History of allergic reactions attributed to excipients or chemical products used in the final GO-203-2c drug formulation
* Known infection with HIV, hepatitis B, or hepatitis C.
* Subjects with risk factors for gastrointestinal perforation or pulmonary hemorrhage (e.g. unresected luminal intestinal cancers; abdominal carcinomatosis within 3 months before the first dose of study drug, abdominal fistula, acute diverticulitis, peptic ulcer disease, irritable bowel syndrome, Crohn's disease, pulmonary hemorrhage, hemoptysis, or tuberculosis)
* Currently receiving or having received treatment with any other investigational agent within 4 weeks prior to Day 1, or not fully recovered from toxicities of prior treatment by Day 1
* Serious and/or poorly controlled non-malignant disease (including but not limited to, ongoing or active infection, hydronephrosis, hypertension, diabetes, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the sponsor. Patients with such conditions should be discussed with the Medical Monitor prior to enrollment. All medical conditions must be NCI CTCAE Grade 1 or lower at baseline.
* Unwillingness or inability to comply with requirements of this protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01279603
Study Brief:
Protocol Section:
NCT01279603