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Advanced Solid TumorsPhase 1NCT00938574

Study With Atu027 in Patients With Advanced Solid Cancer

A Phase 1 study testing Atu027 in people with Advanced Solid Tumors, run by Silence Therapeutics GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
Atu027
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteGermany
Study dates
Jun 2009to Sep 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Dept. of Hematology & Med. Oncology, Univ. of Bochum, Marienhospital Herne

    Herne, 44625

Other trials in Germany

About this study

Official title: 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.

Being tested
Atu027

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atu027Drug

Study groups in NCT00938574
Study groupRoleWhat they receive
Drug Atu027ExperimentalNot described
Receives: Drug: Atu027

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: treatment and follow up

Secondary outcomes (3)

  1. Collection of data concerning pharmacokinetics of Atu027 and its components

    Measured: treatment and follow up

  2. Collection of data concerning clinical safety and tolerability

    Measured: treatment and follow up

  3. Clinical response as measured by RECIST criteria

    Measured: treatment and follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionJul 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00938574
Sponsor's protocol ID
Atu027-I-01
Other IDs
EudraCT-No: 2008-005588-32
Status last verified
Sep 2012
First submitted
13 Jul 2009
Last updated
9 Apr 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25403217

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atu027 in people with Advanced Solid Tumors, run by Silence Therapeutics GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00938574, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2013.

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