Status:
COMPLETED
A Phase I Dose Finding Study of APO010 in Patients With Solid Tumors
Lead Sponsor:
Valerio Therapeutics
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Two-centre, open label, uncontrolled, dose-finding phase I study, to determine the safety and tolerability of APO010 administered by intravenous bolus injection once per week. It will be the first tim...
Detailed Description
Two-centre, open label, uncontrolled, dose-finding phase I study, to determine the safety and tolerability of APO010 administered by intravenous bolus injection once per week in patients with solid tu...
Eligibility Criteria
Inclusion
- Histological/cytological diagnosis of non-resectable solid tumors for which therapy of proven efficacy does not exist or is no longer effective.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Ongoing toxicity associated with prior anticancer therapy ≤Grade 1 (NCI-CTCAE v.3.0).
- No more than 3 prior chemotherapy lines for advanced disease (not including neo/adjuvant chemotherapy; reintroduced chemotherapy is considered only 1 line, e.g. platinum reintroduction in ovarian cancer). Exceptions must to be discussed with, and agreed by the Co-ordinating Investigator.
- Adequate hematological, liver and renal function, e.g.:
- Hemoglobin ≥9 mg/dl; Absolute Neutrophil Count (ANC) ≥1.5x109/l; platelets ≥100x109/l; normal coagulation factors (INR, PTT, PT).
- Serum bilirubin ≤upper normal limit (UNL); ALT, AST ≤ UNL but ≤ 2.5 x UNL in case of liver metastases; alkaline phosphatase (liver isoenzyme fraction) ≤ UNL or ≤1.5 x UNL of in case liver metastases; albumin within normal limits.
- Creatinine ≤1.5 mg/dl (≤133µmole/l) or calculated creatinine clearance ≥60 ml/min.
- Life expectancy of at least 3 months.
- Capability of understanding the nature of the trial and giving written informed consent.
Exclusion
- Less than 4 weeks since last chemotherapy, radiotherapy or prior investigational therapy. Less than 2 weeks since last hormone or immunotherapy or signal transduction therapy.
- More than 30% liver parenchyma involvement assessed by computed tomography (CT) scan.
- History of hypersensitivity to preparations containing human albumin, and to intravenously administered proteins/peptides/antibodies.
- Active infection.
- Presence of cirrhosis with abnormal liver function test or chronic viral hepatitis.
- Presence of serious cardiac (congestive heart failure, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorder.
- Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
- Symptomatic brain metastases, primary brain tumors or leptomeningeal disease.
- Pregnancy or lactation, or unwillingness to use adequate method of birth control
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00437736
Start Date
February 1 2007
End Date
May 1 2009
Last Update
September 17 2015
Active Locations (2)
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1
Oncology Institute of Southern Switzerland, Hospital of Bellinzona
Bellinzona, Switzerland, 6500
2
Multidisciplinary Oncology Center, Cantonal University Hospital of Vaud
Lausanne, Switzerland, 1011