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A Phase 1, Multicenter, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB028 Administered to Subjects With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

A Phase 1, Multicenter, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB028 Administered to Subjects With Advanced Solid Tumors


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Tolerability of BIIB028

Outcome Time Frame:

As specified in Protocol

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

121ST101

NCT ID:

NCT00725933

Start Date:

June 2008

Completion Date:

October 2011

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteAbilene, Texas