Study of XIAP Antisense for Advanced Cancers | NCT00385775

Studies
Study of XIAP Antisense for Advanced Cancers

NCT00385775

Sponsor

Aegera Therapeutics

Status

Terminated

Last Update Posted

Aug 21, 2008Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Advanced Cancer

Interventions

AEG35156

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Dosing cohort (650mg) exceeded current 350mg dosing in other trials.

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Oct 2008Estimated

Completion Date

Nov 2008Estimated

First Submitted Date

Oct 6, 2006

First Submission Date that Met QC Criteria

Oct 6, 2006

First Posted Date

Oct 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2008

Last Update Posted Date

Aug 21, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
AEG35156	Drug	weekly IV solution infused over 2 hrs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		1 year

Secondary Outcomes

Measure	Description	Time Frame
Determine the impact of AEG35156 on inhibition and apoptosis in tumour biopsies or circulating tumour cells.		1 year
Determine the occurence of XIAP knockdown in peripheral blood mononuclear cells.		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided