Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Patients older than 18 years of age
Willing and able to provide informed consent
Patients with histologically or cytologically confirmed diagnosis of advanced solid tumour refractory to standard treatment or for whom no effective therapy exists
Evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 guidelines
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
All female subjects will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically Female subjects of childbearing potential must agree to use two forms of highly effective contraception methods during the study and for a period of 6 months following the last administration of the study drug. Male subjects and their female partners who are of childbearing potential and are not practicing total abstinence, must agree to use two forms of highly effective contraception during the study and for a period of 6 months following the last administration of the study drug
Adequate bone marrow function
Adequate coagulation profile
Adequate hepatic function
Adequate renal function
Life expectancy of at least 3 months, in the opinion of the investigator
Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to ≤ grade 1 (as defined by Common Terminology Criteria for Adverse Events version 4.02).
Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol

Exclusion Criteria:

Patients receiving treatment within 4 weeks prior to study entry with an investigational drug, chemotherapy, targeting agents or hormonal therapy (patients may continue to receive Luteinizing-hormone-releasing hormone analogue therapy for prostate cancer in face of rising PSA), radiation (except to bone) or surgery (except exploratory biopsy or intravenous device implantation, etc.) (6 weeks for nitrosoureas or Mitomycin C, or for investigational drug within 5 half-lives of the treatment, whichever is longer). Participation in non-interventional or observational studies is allowed.
Patients with symptomatic brain metastases. Patients with asymptomatic brain metastases can be included in the study if they are kept on stable doses of steroids for a period of 1 month prior to study entry.
Patients with gastrointestinal abnormalities including inability to take oral medications, malabsorption syndromes or other clinically significant gastrointestinal abnormalities that may impair the absorption of the investigational medicinal product.
Pregnancy or lactation. Serum pregnancy test to be performed within 7 days prior to study treatment start.
Patients with myocardial infarction within ≤ 12 months prior to study entry, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina pectoris, or unstable cardiac arrhythmia requiring medication.
Evidence of preexisting uncontrolled hypertension. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
Patients with known Hepatitis B or C or human immunodeficiency virus (HIV) infection
Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, physical examination or laboratory findings) that in the opinion of the investigator may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.