Clinical trial NCT00725933: Administration of BIIB028 to Subjects With Solid Tumors
Official title: A Phase 1, Multicenter, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB028 Administered to Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2008-07-31
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety and Tolerability of BIIB028


Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability of BIIB028
timeFrame: As specified in Protocol
Secondary outcomes:
measure: PK and PD of BIIB028
timeFrame: As specified in protocol
measure: Antitumor activity
timeFrame: As specified in protocol
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Houston
country: United States
facility: Research Site
state: Texas
Study officials:
References:
citation: 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.