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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Administration of BIIB028 to Subjects With Solid Tumors

NCT00725933

Advanced Solid Tumors

COMPLETED PHASE1

Study of Oral CNF2024 (BIIB021) in Advanced Solid Tumors

NCT00345189

Tumors Lymphoma

COMPLETED PHASE1

Dose Escalation Study of Oral Treatment With BIBW 2992 in Patients With Advanced Solid Tumors

NCT02171637

Neoplasms

COMPLETED PHASE1

A Study of BBI503 in Adult Patients With Advanced Solid Tumors

NCT01781455

Cancer, Advanced Solid Tumors

COMPLETED PHASE1

Dose Escalation Study of Continuous Once-daily Oral Treatment With BIBW 2992 in Patients With Advanced Solid Tumors

NCT02171728

Neoplasms

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

BIIB021

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

BIIB021

Intervention Type DRUG

Twice daily dosing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BIIB021

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

Intervention Type DRUG

BIIB021

Twice daily dosing

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CNF2024 CNF2024

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No