A Phase I Study of BIIB015 in Relapsed/Refractory Solid Tumors

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674947
• Other study ID #: 207ST101
• Status: Completed
• Phase: Phase 1
• First received: May 6, 2008
• Last updated: September 12, 2013
• Start date: June 2008
• Est. completion date: June 2011

Study information

• Verified date: September 2011
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 </= 2.

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.

Study Design

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• BIIB015
IV infusion once every 3 weeks until disease progression or unacceptable toxicity

Locations

Country	Name	City	State
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	San Antonio	Texas
United States	Research Site	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate safety		ongoing	Yes
Primary	To determine the maximum-tolerated dose (MTD)		ongoing	Yes
Secondary	To evaluate pharmacokinetics (PK)		ongoing	No
Secondary	To evaluate clinical activity		ongoing	No