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Effect of Food and Antacid on BIIB021 With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01017198
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : September 16, 2013
Information provided by:

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : January 2011

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

Primary Outcome Measures :
  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. [ Time Frame: Cycle 1, Day 3 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate the safety and tolerability of BIIB021 [ Time Frame: 6 months ]
  3. To evaluate the antitumor activity of BIIB021 [ Time Frame: 6 months ]
  4. To evaluate the effect of BIIB021 on pharmacodynamic biomarkers. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01017198

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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
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Responsible Party: Biogen Idec MD, Biogen Idec Identifier: NCT01017198    
Other Study ID Numbers: 120ST104
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: January 2011
Additional relevant MeSH terms:
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Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents