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: September 12, 2013
Last verified: December 2011

July 29, 2008
September 12, 2013
June 2008
October 2011   (final data collection date for primary outcome measure)
Safety and Tolerability of BIIB028 [ Time Frame: As specified in Protocol ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00725933 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
Drug: BIIB028
IV infusion administered twice weekly until disease progression or unacceptable toxicity
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00725933
121ST101
No
Julie Morrisssey, Quintiles
Biogen Idec
Not Provided
Not Provided
Biogen Idec
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP