A Phase I Study of BIIB015 in Relapsed/Refractory Solid Tumors
A Phase I Study of BIIB015, a Humanized, IgG1, DM4-Conjugated, Anti-Cripto, Monoclonal Antibody, for the Treatment of Subjects With Relapsed or Refractory Solid Tumors
1 other identifier
interventional
55
1 country
3
Brief Summary
Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2008
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2008
CompletedFirst Posted
Study publicly available on registry
May 8, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedSeptember 16, 2013
September 1, 2011
3 years
May 6, 2008
September 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate safety
ongoing
To determine the maximum-tolerated dose (MTD)
ongoing
Secondary Outcomes (2)
To evaluate pharmacokinetics (PK)
ongoing
To evaluate clinical activity
ongoing
Interventions
IV infusion once every 3 weeks until disease progression or unacceptable toxicity
Eligibility Criteria
You may qualify if:
- Age 18 years or older at the time of informed consent.
- Solid tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists.
- ECOG Performance Status \</= 2.
You may not qualify if:
- History of keratoconjunctivitis, open or closed angle glaucoma, or "dry eye" disease.
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction within 6 months prior to Day 1.
- Presence of \>/= Grade 2 peripheral neuropathy.
- Known presence of central nervous system or brain metastases.
- Prior therapy with a conjugated or unconjugated maytansine derivative.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (3)
Research Site
Santa Monica, California, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
San Antonio, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 6, 2008
First Posted
May 8, 2008
Study Start
June 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
September 16, 2013
Record last verified: 2011-09