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An Assessment of the Effect of Food and Antacid on BIIB021 Pharmacokinetics in Subjects With Advanced Solid Tumors.

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumors

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Trial Information

An Assessment of the Effect of Food and Antacid on BIIB021 Pharmacokinetics in Subjects With Advanced Solid Tumors.

This study has 2 phases (the Food Phase and the Antacid Phase), each consisting of a
2-period, 2-sequence, 2-treatment crossover design. The Food Phase will assess the effect
of a high fat meal on the pharmacokinetics of 100 mg BIIB021, and the Antacid Phase will
assess the effect of an antacid (ranitidine) on the pharmacokinetics of 450 mg BIIB021 in
the same subjects. Ranitidine 150 mg will be taken the evening before and the morning of
the antacid dosing day.

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

- Eastern Cooperative Oncology Group (ECOG) performance status of greater or equal to

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective of the study is to assess the pharmacokinetics of BIIB021 taken under fed conditions compared to BIIB021 taken under fasting conditions in subjects with advanced solid tumors.

Outcome Time Frame:

Cycle 1, Day 3

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

January 2011

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms



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