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OpenTrials
Completed

NCT Number: NCT00725933

Administration of BIIB028 to Subjects With Solid Tumors

Safety and Tolerability of BIIB028

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Encinitas, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

BIIB028

Drug

IV infusion administered twice weekly until disease progression or unacceptable toxicity

Primary outcomes

  1. Safety and Tolerability of BIIB028

    Time frame: As specified in Protocol

Secondary outcomes

  1. PK and PD of BIIB028

    Time frame: As specified in protocol

  2. Antitumor activity

    Time frame: As specified in protocol

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Phase 1, Multicenter, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB028 Administered to Subjects With Advanced Solid Tumors

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 31, 2008
Registry last updated
Jan 9, 2017

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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