Study of XIAP Antisense for Advanced Cancers - Full Text View

Sponsored by:	Aegera Therapeutics
Information provided by:	Aegera Therapeutics
ClinicalTrials.gov Identifier:	NCT00385775

Purpose

This study is designed to find the maximum tolerated dose, safety and toxicity profile, and to identify any dose limiting toxicities of AEG35156 administered in 2-hour infusions to patients with advanced cancers.

Condition	Intervention	Phase
Advanced Cancer	Drug: AEG35156	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Trial of AEG35156 Administered by 2-Hour Intravenous Infusion in Patients With Advanced Cancers

Further study details as provided by Aegera Therapeutics:

Primary Outcome Measures:

Dose level at which AEG35156 is well tolerated based upon development of toxicities during the first cycle of therapy unless delayed or cumulative toxicity is encountered. Assessments done weekly. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determine the impact of AEG35156 on inhibition and apoptosis in tumour biopsies or circulating tumour cells. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Determine the occurence of XIAP knockdown in peripheral blood mononuclear cells. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Determine the plasma pharmacokinetic profile of AEG35156. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Determine the possible anti-tumour activity of XIAP. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	June 2006
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

weekly IV solution infused over 2 hrs

Detailed Description:

This is a Phase I study, single-arm, open-label, dose escalation study to establish the recommended dose and activity of AEG35156 administered as a 2-hour daily infusion over 3 days initially followed by weekly 2-hour intravenous infusions in patients with advanced cancers. Subjects eligible for study entry must have proven advanced or metastatic cancer refactory to conventional treatment or for which no conventional therapy exists. The starting dose will be a fixed dose of 60 mg/day with escalation by steps of 50 to 100% in successive cohorts. Approximately of 30 patients will be entered in the study to determine the maximum tolerated dose.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

histologically proven diagnosis of advanced or metastatic cancer (including solid tumours and lymphoma)
refractory to conventional treatment, or for which no conventional therapy exists with life expectancy of at least 12 weeks
ECOG performance status of 0 or 1
hematological and biochemical indices as specified within one week prior to treatment

Exclusion Criteria:

known bleeding diathesis or concurrent treatment with anticoagulants
primary brain tumours or brain metastases
radiotherapy (except palliative), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas and mitomycin-C)
all toxic manifestations of previous treatment must have resolved (excepting alopecia or certain Grade 1 toxicities)
pregnant or lactating women
major thoracic and/or abdominal surgery in the preceding 4 weeks
high medical risks from non-malignant systemic disease including uncontrolled infection
hepatitis B, C or Human Immunodeficiency Virus
allergic history to antisense agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385775

Locations

United Kingdom
Christie Hospital NHS Trust
Manchester, United Kingdom, M20 4BX

Sponsors and Collaborators

Aegera Therapeutics

Investigators

Study Director:

Jacques Jolivet, MD

Aegera Therapeutics Inc.

More Information

Responsible Party:	Aegera Therapeutics Inc ( Jacques Jolivet, MD, Senior VP Clinical )
Study ID Numbers:	AEG35156-104
Study First Received:	October 6, 2006
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00385775
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Aegera Therapeutics:

Cancer
solid tumours
refractory
antisense
oligonucleotide

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009