18 years and older
- Written informed consent must be obtained from the patient.
- Patient must be > 18 years of age.
- Patient must have recurrent or advanced cancer (i.e., solid tumors) for whom standard therapy offers no curative potential.
- Evaluable disease by RECIST v1.1.
- Performance status (PS) of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale. Note: PS 2 patients can only participate if, in the assessment of the clinical investigator, and with the consent of the medical monitor, the patient has the ability to participate in the clinical study for a minimum of at least 2 cycles.
- > 21 days from therapeutic radiation or chemotherapy (>6 weeks from nitrosoureas and mitomycin C) and recovery to (NCI CTCAE v4.03) Grade ≤ 1 from all clinically significant toxicities related to prior therapies.
- Must have adequate organ function defined as:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L.
- Platelet ≥ 100 x 10^9/L.
- Hemoglobin ≥ 9 g/dL.
- Activated partial thromboplastin time/ partial thromboplastin time (aPTT/PTT) ≤ 1.5 x ULN
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN). In the case of known (i.e., radiological or biopsy documented) liver metastasis, serum transaminase levels must be < 5 x ULN.
- Total serum bilirubin ≤ 1.5 x ULN, (except for patients with known Gilbert's Syndrome ≤ 3 x ULN is permitted)
- Renal: Serum creatinine < 2.0 x ULN or creatinine clearance ≥ 50 mL/min/1.73m^2 for patients with serum creatinine levels above 2 x ULN.
- Agreement to use acceptable methods of contraception during the study and for at least 120 days after the last dose of APX3330 if sexually active and able to bear or beget children.
Eastern Cooperative Oncology Group performance status
The Eastern Cooperative Oncology Group (ECOG) performance status allows patients to be classified as to their functional impairment. Scores run from 0 to 5; the higher the ECOG score, the worse the survival rate for most serious cancers. This score allows physicians to evaluate a patient's ability to survive chemotherapy for cancer.
Last dose of chemotherapy