Effect of Food and Antacid on BIIB021 With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Antacids; Anti-Ulcer Agents

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.