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Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00618735
First received: February 8, 2008
Last updated: June 7, 2012
Last verified: January 2011
History of Changes
  Purpose

The purpose of the study is to see if daily and twice daily administration of BIIB021 is tolerated in patients with advanced solid tumors.


Condition Intervention Phase
Advanced Solid Tumors
 Drug: BIIB021
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB021 Administered Once or Twice Daily to 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:
  • Safety and tolerability of BIIB021 [ Time Frame: As specified in protocol ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK and PD of BIIB021 [ Time Frame: As specified in protocol ] [ Designated as safety issue: No ]
  • Antitumor activity [ Time Frame: As specified in protocol ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: February 2008
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Subjects in Schedule A will take BIIB021 in the morning at approximately 0800 with at least 6 ounces of water following an overnight fast (Beginning at midnight).
 Drug: BIIB021
Dosage, frequency (once daily), and duration as specified in protocol. This dosing arm is currently on hold.
Other Name: CNF2024
Experimental: 2
Subjects in Schedule B will take BIIB021 in the morning at approximately 0800 with at least 6 ounces of water following an overnight fast (beginning at midnight). The second dose will be taken, following at least a 2-hour fast, 12 hours (+/- 2 hours) after the first dose, except on Day 1 of Cycle 1 and Day 1 of Cycle 2.
 Drug: BIIB021
Twice daily dosing
Other Name: CNF2024

Detailed Description:

Heat shock protein 90 (HSP90) inhibitors are anticipated to have clinical activity in solid tumors because Hsp90 is required for the folding, activation, and assembly of many proteins involved in cancer cell survival, proliferation, and metastasis. The maximum tolerated dose (MTX) for BIIB021 administered twice weekly in a phase I study in subjects with advanced solid tumors have been defined at 600mg. It is now reasonable from a safety perspective and desirable from a pharmacokinetic perspective to evaluate more frequent dosing intervals in solid tumors with the goal of providing more sustained and completed inhibition of Hsp90.

  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 tumor who have failed or refused standard therapies or for which no approved therapy is available.

Age greater than or equal to 18 years at the time of informed consent. ECOG performance status of less than or equal to 2. Lab values consistent with adequate renal, hepatic, and bone marrow functions.

Exclusion Criteria:

Prior antitumor therapies, including prior experimental agents or approved antitumor small molecules and biologics within 28 days and all associated toxicities resolved to eligibility levels.

Subjects with known brain metastases. Concurrent severe or uncontrolled medical disease. Must utilize effective contraception.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618735

Locations
United States, California
Research Site
Encinitas, California, United States, 92024
Research Site
Santa Monica, California, United States, 90404
United States, Texas
Research Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00618735     History of Changes
Other Study ID Numbers: 120ST103
Study First Received: February 8, 2008
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013