Effect of Food and Antacid on BIIB021 With Advanced Solid Tumors - Full Text View

Purpose

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

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: BIIB021 and Food Drug: BIIB0121 and Antacid	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Assessment of the Effect of Food and Antacid on BIIB021 Pharmacokinetics in Subjects With Advanced Solid Tumors.

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

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. [ Time Frame: Cycle 1, Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Enrollment:	20
Study Start Date:	November 2009
Study Completion Date:	January 2011
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017198

Locations

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

Sponsors and Collaborators

Biogen Idec

More Information

No publications provided

Responsible Party:	Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier:	NCT01017198 History of Changes
Other Study ID Numbers:	120ST104
Study First Received:	November 18, 2009
Last Updated:	June 7, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Antacids
Anti-Ulcer Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013