Effect of Food and Antacid on BIIB021 With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017198
• Other study ID #: 120ST104
• Status: Completed
• Phase: Phase 1
• First received: November 18, 2009
• Last updated: September 12, 2013
• Start date: November 2009
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• BIIB021 and Food
Assessing the effect of food use on BIIB021
• BIIB0121 and Antacid
Assessing the effect of antacid use on BIIB021

Locations

Country	Name	City	State
United States	Reseach Facility	Encinitas	California
United States	Reseach Facility	San Antonio	Texas
United States	Reseach Facility	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	To evaluate the safety and tolerability of BIIB021		6 months	Yes
Secondary	To evaluate the antitumor activity of BIIB021		6 months	No
Secondary	To evaluate the effect of BIIB021 on pharmacodynamic biomarkers.		6 months	No