Study of XIAP Antisense for Advanced Cancers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Advanced Cancer

Keywords

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Cancer solid tumours refractory antisense oligonucleotide

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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AEG35156

weekly IV solution infused over 2 hrs

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Aegera Therapeutics Inc

Principal Investigators

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Jacques Jolivet, MD

Role: STUDY_DIRECTOR

Aegera Therapeutics Inc.

Locations

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Christie Hospital NHS Trust

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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AEG35156-104

Identifier Type: -

Identifier Source: org_study_id