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Phase 1 Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Relapsed/Refractory Solid Tumors
This study is currently recruiting participants.
Verified by Biogen Idec, November 2008
Sponsored by: Biogen Idec
Information provided by: Biogen Idec
ClinicalTrials.gov Identifier: NCT00555724
  Purpose

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


Condition Intervention Phase
Solid Tumors
Drug: BIIB022
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Insulin-like growth factor I Mecasermin rinfabate Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title: A Phase 1, Open Label, Dose Escalation Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Subjects With Relapsed or Refractory Solid Tumors

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of BIIB022 [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
  • To determine the maximum-tolerated dose (MTD) or biologically-effective dose (BED) [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate pharmacokinetics [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • To evaluate the immunogenicity [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • To evaluate clinical activity [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • To conduct biomarker studies. [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: BIIB022
    IV infusion once every three weeks until disease progression or unacceptable toxicity
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must give written informed consent (signed and dated) and any authorizations required by local laws (e.g., Protected Health Information PHI]).
  • Age 18 years or older at the time of informed consent
  • Relapsed or refractory solid tumors following standard therapy.
  • Available formalin-fixed, paraffin-embedded (FFPE) tumor tissue from a tumor tissue biopsy or resection (most recent preferred) submitted either as a paraffin block or as unstained tissue sections on glass slides. Paraffin blocks or unstained slides from core needle biopsies known to contain representative tumor tissue are allowed when larger FFPE tissue samples are not available. (Fine needle aspirates are not acceptable tumor tissue samples for this study.)
  • Measurable or non measurable disease according to modified Response Evaluation Criteria in Solid Tumors (RECIST).
  • ECOG Performance Status 0 or 1.
  • Life expectancy >12 weeks in the opinion of the Investigator.
  • Male and female subjects of child-bearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 9 months after their last dose of study treatment. Effective methods of contraception are double-barrier methods (condoms with spermicidal jelly or foam, and diaphragm with spermicidal jelly or foam); oral, depot, and injectable contraceptives; intrauterine devices (IUDs); NuvaRing; birth control patch (e.g., Ortho Evra patch); or surgical sterilization. Single-barrier methods and rhythm methods will no be considered effective contraception.

Exclusion Criteria:

  • Screening clinical laboratory values:

    • Absolute neutrophil count (ANC) <1000/mcgL
    • Platelet count <75,000/mcgL
    • Hemoglobin <9.0 g/dL. Subjects must not have received transfusions within 4 weeks prior to screening.
    • Serum bilirubin >1.5 x upper limits of normal (ULN)
    • AST and ALT >2.5 X ULN (AST and ALT >5 x ULN for subjects with liver metastasis)
    • Serum creatinine >2.0 mg/dL
    • Albumin </= 2.5 g/dL
  • History of insulin-dependent diabetes, type 2 diabetes, or hemoglobin A1c >6% at screening.
  • History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
  • Known central nervous system or brain metastases.
  • Other malignancies within 3 years of Day 1, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer.
  • Radiation therapy, chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to Day 1.
  • Any investigational therapies administered within 4 weeks prior to Day 1 or 5 half lives of the therapy (whichever is longer).
  • Prior anti-IGF-1R therapy of any kind.
  • Pregnant (positive pregnancy test) or lactating at screening.
  • Inability to comply with study and follow-up procedures.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications.
  • History of claustrophobia or any other condition that is incompatible with the requirements for CT/MRI or FDG-PET scanning.
  • Clinically significant (as determined by the Investigator) electrocardiogram (ECG, 12 lead) abnormalities.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555724

Contacts
Contact: Biogen Idec oncologyclinicaltrials@biogenidec.com

Locations
United States, California
Research Site Recruiting
Los Angeles, California, United States
United States, Colorado
Research Site Recruiting
Aurora, Colorado, United States
United States, Pennsylvania
Research Site Recruiting
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Biogen Idec
  More Information

Responsible Party: Biogen Idec ( Pete Pieslor, MD )
Study ID Numbers: 212ST101
Study First Received: October 31, 2007
Last Updated: November 13, 2008
ClinicalTrials.gov Identifier: NCT00555724  
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Relapsed
refractory
solid tumor

Study placed in the following topic categories:
Antibodies, Monoclonal
Antibodies
Immunoglobulins

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009