Administration of BIIB028 to Subjects With Solid Tumors

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

Safety and Tolerability of BIIB028

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: BIIB028

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and Tolerability of BIIB028	As specified in Protocol

Secondary Outcome Measures

Outcome Measure	Time Frame
Antitumor activity	As specified in protocol
PK and PD of BIIB028	As specified in protocol

Collaborators and Investigators

• Sponsor: Biogen

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: July 29, 2008
• First Submitted That Met QC Criteria: July 29, 2008
• First Posted (Estimate): July 31, 2008

Study Record Updates

• Last Update Posted (Estimate): January 9, 2017
• Last Update Submitted That Met QC Criteria: January 5, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 121ST101