NCT00938574

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 9, 2013

Status Verified

September 1, 2012

Enrollment Period

3.1 years

First QC Date

July 13, 2009

Last Update Submit

April 8, 2013

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (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

    treatment and follow up

Secondary Outcomes (3)

  • 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

  • Clinical response as measured by RECIST criteria

    treatment and follow up

Study Arms (1)

Drug Atu027

EXPERIMENTAL
Drug: Atu027

Interventions

Atu027DRUG
Drug Atu027

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Herne, 44625, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25403217DERIVED

MeSH Terms

Interventions

Atu027

Study Officials

  • Dirk Strumberg,, MD, Prof., Director

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2009

First Posted

July 14, 2009

Study Start

June 1, 2009

Primary Completion

July 1, 2012

Study Completion

September 1, 2012

Last Updated

April 9, 2013

Record last verified: 2012-09

Locations

DE(1)