or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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

Inclusion Criteria


Inclusion Criteria

- 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
Exclusion Criteria

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate safety

Outcome Time Frame:

ongoing

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

207ST101

NCT ID:

NCT00674947

Start Date:

June 2008

Completion Date:

June 2011

Related Keywords:

  • Solid Tumors
  • Relapsed
  • Refractory
  • Neoplasms

Name

Location

Research Site Anaheim, California  
Research Site Allentown, Pennsylvania  
Research Site Abilene, Texas