Effect of Food and Antacid on BIIB021 With Advanced Solid Tumors

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

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

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: BIIB021 and Food; Drug: BIIB0121 and Antacid

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIIB021 and Food; The food phase will assess the effect of a high fat meal on the pharmacokinetics of BIIB021.	Drug: BIIB021 and Food; Assessing the effect of food use on BIIB021
Experimental: BIIB021 and Antacid; Antacid phase will assess the effect of an antacid on the pharmacokinetics of BIIB021.	Drug: BIIB0121 and Antacid; Assessing the effect of antacid use on BIIB021

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Cycle 1, Day 3

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the pharmacokinetics of BIIB021 taken with an antacid (ranitidine) compared to BIIB021 taken with no antacid, both under fasting conditions	Cycle 1, Day 8 and Day 10
To evaluate the safety and tolerability of BIIB021	6 months
To evaluate the antitumor activity of BIIB021	6 months
To evaluate the effect of BIIB021 on pharmacodynamic biomarkers.	6 months

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: November 18, 2009
• First Submitted That Met QC Criteria: November 18, 2009
• First Posted (Estimate): November 20, 2009

Study Record Updates

• Last Update Posted (Estimate): September 16, 2013
• Last Update Submitted That Met QC Criteria: September 12, 2013
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids
• Other Study ID Numbers: 120ST104