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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 November 2012 |
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Main ID: |
NCT00437736 |
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Date of registration:
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20/02/2007 |
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Primary sponsor: |
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Public title:
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A Phase I Dose Finding Study of APO010 in Patients With Solid Tumors
AP1001 |
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Scientific title:
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Phase I Dose Finding and Pharmacokinetic Study of Intravenous APO010, a Recombinant Form of Human Fas Ligand, in Patients With Solid Tumors |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00437736 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Cristiana Sessa, Prof, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oncology Institute of Southern Switzerland, Bellinzona Hospital, 6500 Bellinzona, Switzerland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histological/cytological diagnosis of non-resectable solid tumors for which therapy
of proven efficacy does not exist or is no longer effective.
- 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; ANC =1.5x109/l; platelets =100x109/l; normal coagulation factors
(INR, PTT, PT).
- Serum bilirubin =upper normal limit (UNL); ALT, AST =UNL but = 2.5xUNL in case of
liver metastases; alkaline phosphatase (liver isoenzyme fraction) =UNL or =1.5xUNL 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 Criteria:
- 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 CTscan.
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer
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Intervention(s)
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Drug: APO010
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Primary Outcome(s)
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To determine of the maximum tolerated dose (MTD), based upon first cycle APO010-related DLT in patients with solid tumors.
[Time Frame: 3 months]
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Secondary Outcome(s)
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A definition of the proportion of patients with neutralizing antibodies against APO010.
[Time Frame: 3 months]
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A description of any objective tumor response based on modified RECIST criteria
[Time Frame: 3 months]
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A description of the frequency and severity of adverse events based on the NCI-CTCAE v.3.0.
[Time Frame: 3 months]
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A description of the local toxicity at site of administration by route of administration based on the NCI-Common Terminology Criteria for Adverse Events (NCI-CTCAE v.3.0); the intervention required and by photographic record.
[Time Frame: 3 months]
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Secondary ID(s)
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AP1001
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S065APO01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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