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A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.

NCT ID: NCT00560144

Last Updated: 2016-11-01

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-12-31

Brief Summary

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This 3 arm study will determine the dose of R1507 which will achieve a mean drug exposure in children and adolescents with advanced solid tumors equivalent to the exposure achieved in adults at the recommended dose of 9mg/kg/week. It will also determine the maximum tolerated dose (if appropriate) and the pharmacokinetic profile of R1507. Groups of patients will be sequentially enrolled in one of up to 3 dose levels (3,9mg/kg or a PK-derived dose, not to exceed 16 mg/kg) of R1507 administered weekly by intravenous infusion.An expanded cohort of patients will be enrolled at the optimal dose/MTD. The anticipated time on study treatment is until disease progression or dose limiting toxicity, and the target sample size is \<100 individuals.

Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

3mg/kg iv weekly

2

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

9mg/kg iv weekly

3

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

Pharmacokinetic-derived dose, \<=16mg/kg iv weekly

Interventions

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RG1507

3mg/kg iv weekly

Intervention Type DRUG

RG1507

9mg/kg iv weekly

Intervention Type DRUG

RG1507

Pharmacokinetic-derived dose, \<=16mg/kg iv weekly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* pediatric patients aged 2-17 years of age;
* histologically confirmed solid tumors;
* cancer which has relapsed after, or failed to respond to, curative therapy, or no other potentially curative treatment options available.

Exclusion Criteria

* treatment with corticosteroids within past 2 weeks;
* current or past use of anti-IGF-1R antibodies;
* current treatment with immunosuppressive agents;
* patients with diabetes mellitus;
* known HIV or hepatitis B or C;
* hypersensitivity to any of the components of R1507 or to monoclonal antibodies.
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Tucson, Arizona, United States

Site Status

Denver, Colorado, United States

Site Status

Bethesda, Maryland, United States

Site Status

New York, New York, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NO21200

Identifier Type: -

Identifier Source: org_study_id

NCT00557271

Identifier Type: -

Identifier Source: nct_alias