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

NCT00618735 | Completed Phase 1 DMC

• 1 other identifier: 120ST103
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of BIIB021

  As specified in protocol

Secondary Outcomes (2)

• PK and PD of BIIB021

  As specified in protocol

• Antitumor activity

  As specified in protocol

Study Arms (2)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

Interventions

BIIB021 DRUG

Dosage, frequency (once daily), and duration as specified in protocol. This dosing arm is currently on hold.

Also known as: CNF2024

1

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (3)

Research Site

Encinitas, California, 92024, United States

Location

Research Site

Santa Monica, California, 90404, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Saif MW, Takimoto C, Mita M, Banerji U, Lamanna N, Castro J, O'Brien S, Stogard C, Von Hoff D. A phase 1, dose-escalation, pharmacokinetic and pharmacodynamic study of BIIB021 administered orally in patients with advanced solid tumors. Clin Cancer Res. 2014 Jan 15;20(2):445-55. doi: 10.1158/1078-0432.CCR-13-1257. Epub 2013 Oct 4.

  PMID: 24097863 BACKGROUND

MeSH Terms

Interventions

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

Study Design

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

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 20, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 29, 2016

Record last verified: 2016-12

Locations

US (3)