Effect of Food and Antacid on BIIB021 With Advanced Solid Tumors

NCT ID: NCT01017198

Last Updated: 2013-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-01-31

Brief Summary

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

Detailed Description

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIIB021 and Food

The food phase will assess the effect of a high fat meal on the pharmacokinetics of BIIB021.

Group Type: EXPERIMENTAL

BIIB021 and Food

Intervention Type: DRUG

Assessing the effect of food use on BIIB021

BIIB021 and Antacid

Antacid phase will assess the effect of an antacid on the pharmacokinetics of BIIB021.

Group Type: EXPERIMENTAL

BIIB0121 and Antacid

Intervention Type: DRUG

Assessing the effect of antacid use on BIIB021

Interventions

BIIB021 and Food

Assessing the effect of food use on BIIB021

Intervention Type: DRUG

BIIB0121 and Antacid

Assessing the effect of antacid use on BIIB021

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Biogen Idec

Locations

Reseach Facility

Scottsdale, Arizona, United States

Reseach Facility

Encinitas, California, United States

Reseach Facility

San Antonio, Texas, United States

Countries

United States

Other Identifiers

120ST104

Identifier Type: -

Identifier Source: org_study_id