Administration of BIIB028 to Subjects With Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725933
• Other study ID #: 121ST101
• Status: Completed
• Phase: Phase 1
• First received: July 29, 2008
• Last updated: January 5, 2017
• Start date: June 2008
• Est. completion date: October 2011

Study information

• Verified date: January 2017
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Safety and Tolerability of BIIB028

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• BIIB028
IV infusion administered twice weekly until disease progression or unacceptable toxicity

Locations

Country	Name	City	State
United States	Research Site	Encinitas	California
United States	Research Site	Houston	Texas
United States	Research Site	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of BIIB028		As specified in Protocol	No
Secondary	PK and PD of BIIB028		As specified in protocol	No
Secondary	Antitumor activity		As specified in protocol	No