- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00938574
Study With Atu027 in Patients With Advanced Solid Cancer
April 8, 2013 updated by: Silence Therapeutics GmbH
A Prospective, Open-label, Single Center, Dose Finding Phase I-study With Atu027 (an siRNA Formulation) in Subjects With Advanced Solid Cancer
This is a phase I, prospective, open-label, single center, dose finding study with Atu027 (an siRNA formulation) given as single treatment followed by repeated treatment (repeated treatment phase: 8 treatments within 4 weeks) as therapy in subjects with advanced solid cancer.
Study Overview
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Herne, Germany, 44625
- Dept. of Hematology & Med. Oncology, Univ. of Bochum, Marienhospital Herne
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically and/or cytologically proven advanced, recurrent or metastatic solid malignancy for which standard curative or palliative measures do not exist, are no longer effective, or are unlikely to be effective.
- Age >/= 18 years.
- ECOG performance score of 0-2.
- Life expectancy of at least 3 months.
- Subjects must have recovered from the acute reversible effects of previous anti-cancer therapies. At least 30 days since major surgery and at least 5 half-lives (t1/2) must have elapsed since treatment with any investigational agent.
- Adequate marrow, hepatic, renal, and heart function at the time of screening.
- Weight >/= 50kg.
- Subjects must have at least one measurable lesion according to RECIST.
- Women of childbearing potential must have a negative urine pregnancy test at baseline.
- Women of childbearing potential and men must be willing to use highly effective contraceptive methods during the course of the study and three months after.
- Subjects must be willing and able (in the opinion of the investigator) to understand the subject information and informed consent form and to comply with the study protocol and procedures.
- Subjects must be willing and able to give written informed consent.
Exclusion Criteria:
- Evidence of central nervous system (CNS) metastases.
- Peripheral venous access insufficient to permit intravenous infusion or acquisition of laboratory specimen.
- Major surgery within 30 days prior to first study treatment.
- Evidence that subject has only insufficiently recovered from the acute reversible effects of previous anti-cancer therapies or surgery.
Abnormal hematologic parameters as defined:
- Neutrophil count < 1.500/mm3 (=1.5x10^9/l)
- Platelet count < 100.00/mm3 (=100x10^9/l)
- White blood cells < 3x10^9/l
- Hemoglobin < 9.0 g/l
Abnormal renal or hepatic function as defined:
- ASAT (SGOT), ALAT (SGPT) >/= 1.5xULN or >/= 2.0xULN in case of liver metastases
- Total bilirubin >/= 1.5xULN
- Creatinine clearance < 50ml/min calculated by the Cockroft-Gault formula
- Weight < 50 kg.
Any concurrent disease, medical or social condition that could affect compliance with the protocol or interpretation of results as judged by the investigator. In particular, subjects with the following conditions are not allowed to enter the study:
- Seizures
- Poorly controlled Diabetes mellitus
- Lipid metabolism disorder (cholesterol and triglycerides >/= 1.5xULN), Refsum disease
- Myocardial infarction within six (6) months prior to enrollment or having insufficient cardiac function defined as NYHA Grade 3 or 4, uncontrolled angina, cardiomyopathy, severe uncontrolled ventricular arrhythmias, left bundle branch block or electrocardiographic evidence of acute ischemic or active conduction system abnormalities (e.g. long QT interval, Torsade de Pointes)
- Poorly controlled hypertension
- Severe dyspnea or severe pulmonary dysfunction
- Autoimmune and inflammatory disease
- Active infection or known bacteremia
- Known infection with HIV or chronic infection with hepatitis B or C virus
- History of acute or chronic pancreatitis
- Substance abuse
- Prior gene transfer therapy.
- Concurrent treatment with investigational or commercial agents or therapies administered with the intention to treat the subject's malignancy.
- Participation in any other clinical study or use of investigational device(s) during participation in this study.
- Known hypersensitivity to ingredients of the infusion solution.
- Pregnant or nursing women or women of childbearing potential who are not willing to use highly effective forms of contraception during participation in this study and at least three months thereafter.
- Male subjects with partners of child-bearing potential who are not willing to use highly effective contraception during participation in this study and for at least three months thereafter, unless surgically sterile.
- Subject is a relative of, or staff directly reporting to the investigator or employee of the sponsor.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Drug Atu027
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Determination of dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of single and repeated intravenous infusion with Atu027 in subjects with advanced solid tumors
Time Frame: treatment and follow up
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treatment and follow up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Collection of data concerning pharmacokinetics of Atu027 and its components
Time Frame: treatment and follow up
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treatment and follow up
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Collection of data concerning clinical safety and tolerability
Time Frame: treatment and follow up
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treatment and follow up
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Clinical response as measured by RECIST criteria
Time Frame: treatment and follow up
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treatment and follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dirk Strumberg,, MD, Prof., Director, Dept. of Hematology & Med. Oncology, Univ. of Bochum, Marienhospital Herne
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (ACTUAL)
July 1, 2012
Study Completion (ACTUAL)
September 1, 2012
Study Registration Dates
First Submitted
July 13, 2009
First Submitted That Met QC Criteria
July 13, 2009
First Posted (ESTIMATE)
July 14, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
April 9, 2013
Last Update Submitted That Met QC Criteria
April 8, 2013
Last Verified
September 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- Atu027-I-01
- EudraCT-No: 2008-005588-32
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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