Administration of BIIB028 to Subjects With Solid Tumors

This study has been completed.
Information provided by:
Biogen Identifier:
First received: July 29, 2008
Last updated: September 12, 2013
Last verified: December 2011
Safety and Tolerability of BIIB028

Condition Intervention Phase
Advanced Solid Tumors
Drug: BIIB028
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PK and PD of BIIB028 [ Time Frame: As specified in protocol ] [ Designated as safety issue: No ]
  • Antitumor activity [ Time Frame: As specified in protocol ] [ Designated as safety issue: No ]

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

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

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
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Please refer to this study by its identifier: NCT00725933

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
  More Information

Responsible Party: Julie Morrisssey, Quintiles Identifier: NCT00725933     History of Changes
Other Study ID Numbers: 121ST101 
Study First Received: July 29, 2008
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration processed this record on May 25, 2016