A Phase 1, Multi-center, Open-label, Dose-escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GO-203-2c Given Intravenously Daily X21 Repeated Every 28 Days in Patients With Advanced Solid Tumors Including Lymphomas
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