Administration of BIIB028 to Subjects With Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumors

• Registration Number: NCT00725933
• Lead Sponsor: Biogen

Brief Summary

Safety and Tolerability of BIIB028

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-29
• Study First Submitted QC: 2008-07-29
• Study First Posted: 2008-07-31
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of BIIB028	As specified in Protocol

Secondary Outcome Measures

Name	Time	Method
PK and PD of BIIB028	As specified in protocol
Antitumor activity	As specified in protocol

Trial Locations

Locations (1)

Research Site; 🇺🇸 Houston, Texas, United States