A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RX108 in Patients with Advanced or Metastatic Solid Tumours.
- Conditions
- Advanced or Metastatic Solid TumoursCancer - Any cancer
- Registration Number
- ACTRN12616000008426
- Lead Sponsor
- Suzhou NeuPharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
1.Signed Informed Consent Form
2.Age > 18 years
3.Histologically or cytologically documented cancer
4.Incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed at least one prior systemic therapy or have refused systemic treatment
5.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6.Male or female patients of child-producing potential must agree to use double barrier contraception: condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD), contraceptives (oral, implants or injectable) or other avoidance of pregnancy measures during the study and for 90 days after the last day of treatment
1.Any clinically significant cardiovascular disease including but not limited to:
*New York Heart Association Class II or greater congestive heart failure;
*History of ischaemic cardiac disease, myocardial infarction or unstable angina within 6 months prior to Day 1;
- Hypertrophic obstructive cardiomyopathy;
- History of stroke or transient ischemic attack within 6 months prior to Day 1;
*Presence or history of cardiac conduction abnormalities (increased PR or QRS), atrioventricular block or arrhythmias including intermittent complete heart block or second degree atrioventricular block, history of Stokes-Adams attacks, ventricular tachycardia, ventricular fibrillation or supraventricular arrhythmias;
2.Use of the following concurrent medications: beta blockers, digoxin, calcium channel blockers, amiodarone, flecainide, quinidine, and any other anti-arrhythmic.
3.Known contra-indication, intolerance or hypersensitivity to digoxin
4.Inadequate hematologic and organ function, defined by the following
*Absolute neutrophil count < 1.5x109/L, haemoglobin < 9 g/dL
*Total bilirubin 1.5 x the upper limit of normal (ULN) with the following exception: Patients with known Gilbert disease who have serum bilirubin level > 3 x the ULN and normal Aspartate Transaminase (AST)/ Alanine Transaminase (ALT) may be enrolled.
*AST and/or ALT > 2.5 x the ULN with the following exception: Patients with documented liver metastases may have AST and/or ALT levels > 5 x the ULN.
*Serum creatinine > 1.5 x the ULN with the following exception: A creatinine clearance of 50 mL/min based on a calculated glomerular filtration rate (GFR) (e.g. Cockcroft-Gault formula)
*International normalized ratio (INR) > 1.5 x the ULN or activated partial thromboplastin time (aPTT) > 1.5 x the ULN. The INR applies only to patients who do not receive therapeutic anti-coagulation.
*Serum electrolytes (Sodium, Calcium, Potassium, Magnesium) within normal limits.
5.Severe respiratory disease.
6.Any unapproved concurrent therapies for cancer (complementary or alternative therapies), or any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy, radiotherapy, or herbal therapy within 4 weeks prior to initiation of study treatment with the following exceptions:
*Hormonal therapy with gonadotropin-releasing hormone agonists for prostate cancer at stable doses for at least 30 days prior to study entry
*Hormone-replacement therapy or oral contraceptives at stable doses for at least 30 days prior to study entry
*Palliative radiation to bone metastases acceptable within 2 weeks prior to Day 1
7.AEs from prior anti-cancer therapy that have not resolved to CTCAE Grade 1, except for alopecia.
8.Clinically significant active infection.
9.Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
10.Known human immunodeficiency virus infection.
11.Pregnant (positive pregnancy test) or lactating women.
12.Active or untreated brain metastasis.
13.Inability to comply with study and follow-up procedures.
14.Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the Investigator’s opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method