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Administration of BIIB028 to Subjects With Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00725933
First Posted: July 31, 2008
Last Update Posted: January 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
  Purpose
Safety and Tolerability of BIIB028

Condition Intervention Phase
Advanced Solid Tumors Drug: BIIB028 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB028 Administered to Subjects With Advanced Solid Tumors

Further study details as provided by Biogen:

Primary Outcome Measures:
  • Safety and Tolerability of BIIB028 [ Time Frame: As specified in Protocol ]

Secondary Outcome Measures:
  • PK and PD of BIIB028 [ Time Frame: As specified in protocol ]
  • Antitumor activity [ Time Frame: As specified in protocol ]

Enrollment: 43
Study Start Date: June 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: BIIB028
    IV infusion administered twice weekly until disease progression or unacceptable toxicity
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
  • Age greater than or equal to 18 years at the time of informed consent.
  • Subjects with histological or cytological confirmed solid tumors who have failed standard therapies or for which no standard therapy is available.
  • Anticipated survival of at least 3 months in the opinion of the Investigator.
  • ECOG performance status of less than or equal to 2.
  • Lab values consistent with adequate renal hepatic and bone marrow function.
  • Must utilize effective contraception.

Exclusion Criteria:

  • Pregnant (positive pregnancy test) or nursing women
  • Prior treatment with Hsp90 inhibitors at any time.
  • Prior antitumor therapies including prior experimental agents, approved antitumor small molecules and biologics, or radiotherapy with in 28 days or <3 half lives (whichever is longer). In addition,prior to enrollment, all asociated toxicities must have been resolved to eligibility levels.
  • Concurrent severe or uncontrolled other 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 assessment of safety.
  • Use of anticoagulants, except low dose warfarin.
  • History of seizure, previous significant head trauma (e.g., associated with loss of consciousness for more than 5 minutes), abrupt discontinuation of benzodiazepines, or use of potentially epileptogenic medication
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725933


Locations
United States, California
Research Site
Encinitas, California, United States, 92024
Research Site
Los Angeles, California, United States
United States, Texas
Research Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Biogen