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

October 29, 2016 updated by: Hoffmann-La Roche

Multiple Ascending Dose (MAD) Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion in Pediatric Patients With Advanced Solid Tumors.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
    • Colorado
      • Denver, Colorado, United States, 80218
    • Maryland
      • Bethesda, Maryland, United States, 20982
    • New York
      • New York, New York, United States, 10017
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: RG1507
3mg/kg iv weekly
Drug: RG1507
9mg/kg iv weekly
Drug: RG1507
Pharmacokinetic-derived dose, <=16mg/kg iv weekly
Experimental: 2
Drug: RG1507
3mg/kg iv weekly
Drug: RG1507
9mg/kg iv weekly
Drug: RG1507
Pharmacokinetic-derived dose, <=16mg/kg iv weekly
Experimental: 3
Drug: RG1507
3mg/kg iv weekly
Drug: RG1507
9mg/kg iv weekly
Drug: RG1507
Pharmacokinetic-derived dose, <=16mg/kg iv weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum drug exposure level equivalent to exposure in adults at adult recommended dose.
Time Frame: Throughout study
Throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
MTD (AEs, laboratory parameters)
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 16, 2007

First Submitted That Met QC Criteria

November 16, 2007

First Posted (Estimate)

November 19, 2007

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 29, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NO21200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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