Administration of BIIB028 to Subjects With Solid Tumors
This study has been completed.
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00725933
First received: July 29, 2008
Last updated: June 7, 2012
Last verified: December 2011
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Purpose
Safety and Tolerability of BIIB028
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: BIIB028 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Multicenter, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB028 Administered to Subjects With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Biogen Idec:
Primary Outcome Measures:
- Safety and Tolerability of BIIB028 [ Time Frame: As specified in Protocol ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 43 |
| Study Start Date: | June 2008 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: BIIB028
IV infusion administered twice weekly until disease progression or unacceptable toxicity
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725933
Locations
| United States, California | |
| Research Site | |
| Encinitas, California, United States, 92024 | |
| Research Site | |
| Los Angeles, California, United States | |
| United States, Texas | |
| Research Site | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Biogen Idec
More Information
No publications provided
| Responsible Party: | Julie Morrisssey, Quintiles |
| ClinicalTrials.gov Identifier: | NCT00725933 History of Changes |
| Other Study ID Numbers: | 121ST101 |
| Study First Received: | July 29, 2008 |
| Last Updated: | June 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 21, 2013