Table 3 General exclusion criteria
General exclusion criteria (abbreviated) | |
|---|---|
1) Ongoing toxicity > CTCAE grade 2. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3. | |
2) Prior treatment with the selected study drug. | |
3) Genomic alterations known to confer drug resistance. | |
4) Current treatment with other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement). Medications prescribed for supportive care that may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates) or ongoing castration-intent therapy for prostate cancer, are accepted if they have been started ≥1 month prior to enrollment. | |
5) Female patients who are pregnant or nursing. Male and female patients who refuse to practice highly effective contraception methods. | |
6) Patients with known progressive brain metastases determined by serial imaging or declining neurologic function in the opinion of the treating physician. Patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month prior to study enrollment. | |
7) Patients with preexisting uncontrolled cardiac conditions, LVEF known to be < 40%, stroke (including TIA) or acute myocardial infarction within 4 months before the first dose. | |
8) Patients with acute gastrointestinal bleeding within 1 month of start of treatment. | |
9) Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study e.g., active infection, significant uncontrolled hypertension, severe psychiatric illness situations, or anticipated or planned anti-cancer treatment or surgery. | |
10) Patients who do not meet drug-specific eligibility requirements for the drug selected. | |
11) Patients whose disease is not measurable or assessable by radiographic imaging or physical examination (e.g., elevated serum tumor marker only) with the exception of ovarian cancer (CA-125) and prostate cancer (PSA). | |
12) Patients with known allergy/hypersensitivity to the study drug. |