Administration of BIIB028 to Subjects With Solid Tumors

This study has been completed.

Sponsor:

Information provided by:

Biogen Idec

ClinicalTrials.gov Identifier:

NCT00725933

First received: July 29, 2008

Last updated: June 7, 2012

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 29, 2008
Last Updated Date	June 7, 2012
Start Date ^ICMJE	June 2008
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 29, 2008)	Safety and Tolerability of BIIB028 [ Time Frame: As specified in Protocol ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00725933 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 29, 2008)	PK and PD of BIIB028 [ Time Frame: As specified in protocol ] [ Designated as safety issue: No ] Antitumor activity [ Time Frame: As specified in protocol ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Administration of BIIB028 to Subjects With Solid Tumors
Official Title ^ICMJE	A Phase 1, Multicenter, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB028 Administered to Subjects With Advanced Solid Tumors
Brief Summary	Safety and Tolerability of BIIB028
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Advanced Solid Tumors
Intervention ^ICMJE	Drug: BIIB028 IV infusion administered twice weekly until disease progression or unacceptable toxicity
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	43
Completion Date	October 2011
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00725933
Other Study ID Numbers ^ICMJE	121ST101
Has Data Monitoring Committee	No
Responsible Party	Julie Morrisssey, Quintiles
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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