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Completed

NCT Number: NCT00674947

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

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

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Key information

Conditions

Solid Tumors Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Santa Monica, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIIB015

Drug

IV infusion once every 3 weeks until disease progression or unacceptable toxicity

Primary outcomes

  1. To evaluate safety

    Time frame: ongoing

  2. To determine the maximum-tolerated dose (MTD)

    Time frame: ongoing

Secondary outcomes

  1. To evaluate pharmacokinetics (PK)

    Time frame: ongoing

  2. To evaluate clinical activity

    Time frame: ongoing

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 8, 2008
Registry last updated
Sep 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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