Effect of Food and Antacid on BIIB021 With Advanced Solid Tumors

NCT01017198 | Completed Phase 1 DMC

• 1 other identifier: 120ST104
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

BIIB021 and Food

EXPERIMENTAL

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

Drug: BIIB021 and Food

BIIB021 and Antacid

EXPERIMENTAL

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

Drug: BIIB0121 and Antacid

Interventions

BIIB021 and Food DRUG

Assessing the effect of food use on BIIB021

BIIB021 and Food

BIIB0121 and Antacid DRUG

Assessing the effect of antacid use on BIIB021

BIIB021 and Antacid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (3)

Reseach Facility

Scottsdale, Arizona, United States

Location

Reseach Facility

Encinitas, California, United States

Location

Reseach Facility

San Antonio, Texas, United States

Location

MeSH Terms

Interventions

6-chloro-9-(4-methoxy-3,5-dimethylpyridin-2-ylmethyl)-9H-purin-2-ylamine; Food; Antacids

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Gastrointestinal Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 20, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: January 1, 2011
• Last Updated: September 16, 2013

Record last verified: 2011-01

Locations

US (3)