Administration of BIIB028 to Subjects With Solid Tumors

NCT00725933 | Completed Phase 1

• 1 other identifier: 121ST101
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

Brief Summary

Safety and Tolerability of BIIB028

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of BIIB028

  As specified in Protocol

Secondary Outcomes (2)

• PK and PD of BIIB028

  As specified in protocol

• Antitumor activity

  As specified in protocol

Interventions

BIIB028 DRUG

IV infusion administered twice weekly until disease progression or unacceptable toxicity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (3)

Research Site

Encinitas, California, 92024, United States

Location

Research Site

Los Angeles, California, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 23873691 BACKGROUND

MeSH Terms

Interventions

HSP90 Heat-Shock Proteins

Intervention Hierarchy (Ancestors)

Heat-Shock Proteins; Molecular Chaperones; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2008
• First Posted: July 31, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 9, 2017

Record last verified: 2017-01

Locations

US (3)