Effect of Food and Antacid on BIIB021 With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

This study is designed to assess the effect of food and antacid use on the pharmacokinetic properties of BIIB021.

Key facts

Study ID

NCT01017198

Run by

Biogen

People needed

20

Starts

2009-11-01

Expected to finish

2011-01-01

Last updated by the study team

2013-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with histologically or cytologically confirmed solid tumors who have failed or are not candidates for standard therapies or for whom no approved therapy is available.
• Eastern Cooperative Oncology Group (ECOG) performance status of greater or equal to 2.
• Medically able to tolerate a high fat meal and to fast as per protocol.
• Expected survival time of at least 3 months in the opinion of the Investigator.
• Ability to take ranitidine as per protocol.
• Must be able to swallow and retain oral medication.
• Lab values consistent with adequate renal, hepatic, and bone marrow functions.
• Electrocardiogram (ECG) with QTc of ≤450 msec for men or ≤470 msec for women and no clinically significant findings.

You may not qualify if…

• Pregnant (positive pregnancy test) or nursing women.
• Previous treatment with an Hsp90 inhibitor.
• Use of antacids within 7 days of Study Day 1.
• Prior antitumor therapies, including prior experimental agents or approved antitumor therapies within 28 days of the first dose of BIIB021.
• Major surgery or radiation within 28 days of the first dose of BIIB021.
• Uncontrolled, severe medical illness, which in the opinion of the Investigator and/or Sponsor could compromise protocol objectives.
• History of gastrectomy or major surgery to small intestine.
• History of exocrine pancreatic insufficiency.
• Chronic diarrhea (excess of 2 to 3 stools/day above normal frequency).
• Active bacterial or viral infection requiring concurrent treatment.
• History of hepatitis B or C or human immunodeficiency virus.
• History of central nervous system metastasis.
• Any thrombotic event occurred <3 months prior to Day 1.
• Conditions that may predispose subjects to seizures: History of seizure, previous significant head trauma
• Drug or alcohol abuse.

Where it is running

• Reseach Facility — Scottsdale, Arizona, United States
• Reseach Facility — Encinitas, California, United States
• Reseach Facility — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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