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CompletedNCT00725933Updated Jan 9, 2017

Administration of BIIB028 to Subjects With Solid Tumors

A Phase 1 interventional study of BIIB028 in Advanced Solid Tumors, sponsored by Biogen. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-09.

Sponsored by Biogen · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
43
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Safety and Tolerability of BIIB028

02

Conditions studied

  • Advanced Solid Tumors
03

In context

Lead sponsor

Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 49 (49%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Interventions

  • DrugBIIB028

    IV infusion administered twice weekly until disease progression or unacceptable toxicity

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability of BIIB028

    Time frame: As specified in Protocol

Secondary outcomes

  1. PK and PD of BIIB028

    Time frame: As specified in protocol

  2. Antitumor activity

    Time frame: As specified in protocol

07

Study locations

3 sites
  • Research Site
    Encinitas, California 92024, United States
  • Research Site
    Los Angeles, California, United States
  • Research Site
    Houston, Texas 77030, United States
08

References and documents

Publications

  • Hong D, Said R, Falchook G, Naing A, Moulder S, Tsimberidou AM, Galluppi G, Dakappagari N, Storgard C, Kurzrock R, Rosen LS. Phase I study of BIIB028, a selective heat shock protein 90 inhibitor, in patients with refractory metastatic or locally advanced solid tumors. Clin Cancer Res. 2013 Sep 1;19(17):4824-31. doi: 10.1158/1078-0432.CCR-13-0477. Epub 2013 Jul 19. PubMed 23873691 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00725933
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Jul 31, 2008
Start date
Jun 2008
Primary completion
Oct 2011
Completion
Oct 2011
Last update
Jan 9, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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