Intravenous APG-1387 administered to patients with advanced solid tumors and lymphomas to test for safety, tolerability and effect of APG-1387 on the body and how APG-1387 is processed by the human body
- Conditions
- advanced solid tumorlymphomaCancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphomaCancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphomaCancer - Any cancer
- Registration Number
- ACTRN12614000268640
- Lead Sponsor
- Jiangsu Ascentage Pharma Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 30
Histologically or cytologically confirmed solid tumor or lymphoma;
-Male or non-pregnant, non-lactating female patients age greater than or equal to 18 years;
-Locally advanced or metastatic disease for which no standard therapy is judged appropriate by the investigator;
-Life expectancy greater than or equal to 3 months;
-Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1;
-Adequate hematologic function as indicated by:
ANC greater than or equal to 1,500/mm3; Hemoglobin greater than or equal to 9.0 g/dL; platelet count greater than or equal to 100,000/mm3
-QTc interval less than or equal to 450ms
-Adequate renal and liver function as indicated by:
-Serum creatinine less than or equal to 1. x ULN or if serum creatinine is >1.5 X ULN, creatinine clearance of greater than or equal to 50 cc/min; total bilirubin less than or equal to 1.5 x ULN
AST and ALT less than or equal to 2.5 x ULN ; Alkaline phosphatase less than or equal to 2.5 x ULN
-Negative Hepatitis B and Hepatitis C screening:
-Willingness to use contraception by a method that is deemed effective by the investigator by both males and female patients of child bearing potential (postmenopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential) and their partners throughout the treatment period and for at least one month following the last dose of study drug;
-Ability to understand and willingness to sign a written informed consent form; the consent form must be signed by the patient prior to any study-specific procedures;
-Willingness and ability to comply with study procedures and follow-up examination.
-Received chemotherapy within 21 days (42 days for nitrosoureas or mitomycin C) prior to entering the study;
Received hormonal, biologic therapies (e.g. interferons), or therapeutic antibodies (e.g. trastuzumab, cetuximab, rituximab, etc) within 21 days or <4 half-lives (whichever is greater) of study entry;
Note: Leuteinizing hormone-releasing hormone (LHRH) agonists or antagonists to maintain castrate levels of testosterone in patients with hormone-refractory prostate cancer is allowed. Oral contraceptives and estrogen/progestogen HRT are acceptable
-Receiving concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy); or has had tumor embolization within 14 days of study entry.
-Radiation within 14 days of study entry, thoracic radiation within 28 days of study entry. Patients who have received prior radiotherapy must have discontinued steroids for 14 days prior to study entry and be clinically stable;
-Failure to recover to less than or equal to Grade 1 from adverse events due to radiotherapy or chemotherapy agents;
-Requirement for corticosteroid treatment, with the exception of megestrol, topical corticosteroids and inhaled corticosteroids for reactive airway disease. Patients who received prior therapy with corticosteroids must have discontinued use of corticosteroid therapy 14 days prior to the first dose of APG-1387 ; The patients who require replacement dose corticosteroids are allowed (eg if they have had endocrinopathy from ipilimumab)
-Use of therapeutic doses of anti-coagulants is excluded. Therapeutic is defined as a target International Normalized Ratio (INR) of 1.5 or above. However, the prophylactic dose anticoagulation is allowed.
-Concurrent treatment with an investigational agent or device within 28 days prior to the first dose of therapy;
-Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients with active wound healing, patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry;
-Elevated (above institutional normal limits) serum troponin T or I.
-Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry.
-Neurologic instability per clinical evaluation due to tumor involvement of the central nervous system (CNS). Patients with CNS tumors that have been treated, are asymptomatic and who have discontinued steroids (for the treatment of CNS tumors) for >28 days may be enrolled;
-History of Bell’s palsy
-Active rheumatoid arthritis (RA), active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation;
-Active symptomatic fungal, bacterial and/or viral infection including, but not limited to, active HIV or viral hepatitis (A, B or C);
-Known or suspected Wilson's Disease, or other conditions that affect copper accumulation or regulation.
-Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
-Prior treatment with IAP inhibitors.
-Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method