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


Phase 1
2 Years
17 Years
Not Enrolling
Both
Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Serum drug exposure level equivalent to exposure in adults at adult recommended dose.

Outcome Time Frame:

Throughout study

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NO21200

NCT ID:

NCT00560144

Start Date:

December 2007

Completion Date:

December 2011

Related Keywords:

  • Neoplasms
  • Neoplasms

Name

Location

Phoenix, Arizona  85012
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Denver, Colorado  
Baltimore, Maryland  21287