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A Phase I Study of BIIB015 in Relapsed/Refractory Solid Tumors

NCT ID: NCT00674947

Last Updated: 2013-09-16

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-06-30

Brief Summary

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Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.

Detailed Description

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Conditions

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Solid Tumors

Keywords

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Relapsed Refractory

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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BIIB015

IV infusion once every 3 weeks until disease progression or unacceptable toxicity

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older at the time of informed consent.
* Solid tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists.
* ECOG Performance Status \</= 2.

Exclusion Criteria

* History of keratoconjunctivitis, open or closed angle glaucoma, or "dry eye" disease.
* New York Heart Association (NYHA) Grade II or greater congestive heart failure.
* History of myocardial infarction within 6 months prior to Day 1.
* Presence of \>/= Grade 2 peripheral neuropathy.
* Known presence of central nervous system or brain metastases.
* Prior therapy with a conjugated or unconjugated maytansine derivative.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Quintiles, Inc.

Locations

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Research Site

Santa Monica, California, United States

Site Status

Research Site

Philadelphia, Pennsylvania, United States

Site Status

Research Site

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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207ST101

Identifier Type: -

Identifier Source: org_study_id