A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sterile Compound c31510 for Injection Administered Intravenously to Subjects With Solid Tumors
- The subject has a histologically confirmed solid tumor that is metastatic or
unresectable for which standard curative measures do not exist or are no longer
- The subject is at least 18 years old.
- The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2.
- The subject has a life expectancy of greater than 3 months.
- The subject has organ and marrow function as follows: ANC>1500mm3, platelets>100,000
dl, hemoglobin >9 g/dL, bilirubin ≤ 1.5mg/dL, serum creatinine ≤1.5mg/dL or
creatinine clearance >60 mL/min, and alanine aminotransferase (ALT), aspartate
transaminase (AST) ≤2.5 times the upper limit of normal if no liver involvement or ≤5
times the upper limit of normal with liver involvement.
- The subject is capable of understanding and complying with the protocol and has
signed the informed consent document.
- Sexually active subjects must use an accepted method of contraception during the
course of the study.
- Female patients of childbearing potential must have a negative pregnancy test at
- If a subject has received more than three prior regimens of cytotoxic chemotherapy,
or more than two biological regimens, or more than 3000cGy to areas containing
substantial marrow, the cohort review committee (CRC) must determine subject
suitability prior to enrollment.
- The subject has received chemotherapy or radiotherapy within 4 weeks or has received
nitrosoureas or mitomycin C within 6 weeks prior to entering the study.
- The subject has received anti-angiogenesis drugs within 4 weeks prior to entering the
- The subject has received radiation to ≥25% of his or her bone marrow within 4 weeks
of C31510IV treatment.
- The subject has received an investigational drug within 30 days of the first dose of
study drug. 6 of 72
- The subject has not recovered to grade ≤1 from adverse events( AEs) due to
investigational drugs or other medications, which were administered more than 4 weeks
prior to study enrollment.
- The subject has uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements.
- The subject is pregnant or lactating.
- The subject is known to be positive for the human immunodeficiency virus (HIV)
- The subject has an inability or unwillingness to abide by the study protocol or
cooperate fully with the investigator or designee.
- Must have not taken Vitamin D3 supplements in the last 30 days
- The subject is on HMG-CoA Reductase Inhibitors
- The subject is receiving digoxin, digitoxin, lanatoside C or any type of digitalis
- The subject is receiving Colony Stimulating factors. The use of Colony Stimulating
factors isf prohibited during the monitoring of DLT in this study.
- The subject is receiving Warfarin.