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Phase Ib Study To Evaluate The Safety Of Combining IGF-1R Antagonist R1507 With Multiple Standard Chemotherapy Drug Treatments In Patients With Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

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Trial Information

Phase Ib Study To Evaluate The Safety Of Combining IGF-1R Antagonist R1507 With Multiple Standard Chemotherapy Drug Treatments In Patients With Advanced Malignancies


Inclusion Criteria:



- adult patients, >=18 years of age;

- malignant neoplasms;

- failed prior standard curative therapy;

- ECOG performance Status of 0 or 1;

- adequate bone marrow, hepatic and renal function;

- life expectancy greater than 8 weeks.

Exclusion Criteria:

- chemotherapy within 2 weeks of start of therapy;

- prior irradiation within 4 weeks prior to start of therapy;

- prior treatment with agents targeting IGF-IR inhibition, or other investigational
agents;

- major surgery or significant traumatic injury within 2 weeks prior to study start;

- patients receiving concurrent antibody or immunotherapy;

- other exclusion criteria are related to specific treatment regimens.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Adverse events, laboratory parameters, vital signs

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:

NO22068

NCT ID:

NCT00811993

Start Date:

January 2009

Completion Date:

March 2013

Related Keywords:

  • Neoplasms
  • Neoplasms

Name

Location

Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Phoenix, Arizona  85012
Fountain Valley, California  92708
Austin, Texas  78705
Omaha, Nebraska  68114
Washington, District of Columbia