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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT-No: 2008-005588-32 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Atu027 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atu027 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | treatment and follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of data concerning pharmacokinetics of Atu027 and its components | treatment and follow up | |
| Collection of data concerning clinical safety and tolerability | treatment and follow up | |
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Inclusion Criteria:
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:
Abnormal renal or hepatic function as defined:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Dirk Strumberg,, MD, Prof., Director | Dept. of Hematology & Med. Oncology, Univ. of Bochum, Marienhospital Herne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Hematology & Med. Oncology, Univ. of Bochum, Marienhospital Herne | Herne | 44625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25403217 | Derived | Schultheis B, Strumberg D, Santel A, Vank C, Gebhardt F, Keil O, Lange C, Giese K, Kaufmann J, Khan M, Drevs J. First-in-human phase I study of the liposomal RNA interference therapeutic Atu027 in patients with advanced solid tumors. J Clin Oncol. 2014 Dec 20;32(36):4141-8. doi: 10.1200/JCO.2013.55.0376. Epub 2014 Nov 17. |
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| ID | Term |
|---|---|
| C561746 | Atu027 |
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| Clinical response as measured by RECIST criteria |
| treatment and follow up |