Effect of Food and Antacid on BIIB021 With Advanced Solid Tumors

Sponsor

Biogen (Industry)

Overall Status

Completed

CT.gov ID

NCT01017198

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

6.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: BIIB021 and Food Drug: BIIB0121 and Antacid	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (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.

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

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

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

Outcome Measures

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. [Cycle 1, Day 3]

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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Reseach Facility	Scottsdale	Arizona	United States
2	Reseach Facility	Encinitas	California	United States
3	Reseach Facility	San Antonio	Texas	United States

Sponsors and Collaborators

Biogen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01017198

Other Study ID Numbers:

120ST104

First Posted:

Nov 20, 2009

Last Update Posted:

Sep 16, 2013

Last Verified:

Jan 1, 2011

Additional relevant MeSH terms:

Neoplasms

Antacids

Study Results

No Results Posted as of Sep 16, 2013