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Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid Tumors
This study is currently recruiting participants.
Verified by Biogen Idec, December 2008
Sponsored by: Biogen Idec
Information provided by: Biogen Idec
ClinicalTrials.gov Identifier: NCT00618735
  Purpose

The purpose of the study is to see if daily and twice daily administration of BIIB021 is tolerated in patients with advanced solid tumors.


Condition Intervention Phase
Advanced Solid Tumors
Drug: BIIB021
Phase I

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment
Official Title: A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB021 Administered Once or Twice Daily to Subjects With Advanced Solid Tumors

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Safety and tolerability of BIIB021 [ Time Frame: As specified in protocol ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK and PD of BIIB021 [ Time Frame: As specified in protocol ] [ Designated as safety issue: No ]
  • Antitumor activity [ Time Frame: As specified in protocol ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: February 2008
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Once daily dosing
Drug: BIIB021
Dosage, frequency (once daily), and duration as specified in protocol. This dosing arm is currently on hold.
2: Experimental
Twice daily dosing
Drug: BIIB021
Twice daily dosing

  Eligibility

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

Inclusion Criteria:

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
  • Subjects with histologically or cytologically confirmed solid tumor who have failed or refused standard therapies or for which no approved therapy is available.
  • Age greater than or equal to 18 years at the time of informed consent.
  • ECOG performance status of less than or equal to 2.
  • Required laboratory values:

    • ANC greater than or equal to 1500 cells/mm3
    • Platelet count greater than or equal to 100,000 cells/mm3
    • Hemoglobin greater than or equal to 9 gm/L
    • Total bilirubin less than or equal to1.5 x upper limit of normal (ULN)
    • ALT or AST less than or equal to 2.5 x ULN
    • Serum creatinine less than or equal to 2.0 x ULN or calculated creatinine clearance greater than or equal to 60 mL/min/1.73m2
    • INR less than or equal to 1.3
  • Plasma cortisol and ACTH
  • Male and female subjects of childbearing potential must practice effective double barrier contraception during the study and continue contraception for 3 months after their last dose of study treatment.

Exclusion Criteria:

  • Pregnant (positive pregnancy test) or nursing women.
  • Prior treatment with Hsp90 inhibitors at any time.
  • Prior antitumor therapies, including prior experimental agents or approved antitumor small molecules and biologics within 28 days and all associated toxicities resolved to eligibility levels.
  • Prior radiation or surgery should have been completed greater than or equal to 4 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels.
  • Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other AEs.
  • Concurrent severe or uncontrolled medical disease (i.e., diabetes, hypertension, coronary artery disease, congestive heart failure), which in the opinion of the Investigator and/or the Sponsor could compromise protocol objectives.
  • Subjects with screening or baseline prolongation of QTc interval > 450 msec for males or > 470 msec for females.
  • Myocardial infarction within past 12 months from time of enrollment in this study.
  • History of arterial or venous thrombosis within past 6 months from time of enrollment in this study.
  • Red blood cell (RBC) or platelet transfusion within 30 days of screening.
  • Active symptomatic fungal, bacterial, and/or known viral infection, including active HIV or viral (A, B, or C) hepatitis including hepatitis C-seropositivity (unless HCV RNA PCR negative), or hepatitis B surface antigen (HBsAg)-seropositivity
  • Problems with swallowing or malabsorption.
  • Chronic diarrhea (excess of 2 to 3 stools/day above normal frequency).
  • Inflammatory gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.
  • History of gastrectomy or major surgery to the small intestine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618735

Contacts
Contact: Biogen Idec oncologyclinicaltrials@biogenidec.com

Locations
United States, California
Research Site Recruiting
Los Angeles, California, United States
United States, Texas
Research Site Recruiting
San Antonio, Texas, United States
Sponsors and Collaborators
Biogen Idec
  More Information

Responsible Party: Biogen Idec ( Biogen Idec MD )
Study ID Numbers: 120ST103
Study First Received: February 8, 2008
Last Updated: December 10, 2008
ClinicalTrials.gov Identifier: NCT00618735  
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on January 16, 2009