Study of Oral CNF2024 (BIIB021) in Advanced Solid Tumors - Full Text View

Purpose

This is an open-label, multicenter, dose-escalation, safety, pharmacokinetics, and pharmacodynamics study.

Condition	Intervention	Phase
Tumors Lymphoma	Drug: CNF2024	Phase I

MedlinePlus related topics:

Cancer Lymphoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CNF2024 Administered Orally Twice Weekly for Three Weeks of a Four Week Course or Twice Weekly for Four Weeks of a Four Week Course to Patients With Advanced Solid Tumors

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

To determine the maximum tolerated dose (MTD) [ Time Frame: Dose escalation will proceed according to the predetermined scheme until the stopping dose (dose > MTD) is reached due to a dose limiting toxicities (DLT) occurring during the first 4-week course of treatment. ] [ Designated as safety issue: Yes ]
To determine the safety profile [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
pharmacokinetic profile [ Time Frame: Dosing period ] [ Designated as safety issue: No ]
effect on pharmacodynamic biomarkers [ Time Frame: Dosing period ] [ Designated as safety issue: No ]
antitumor activity [ Time Frame: At screening and after every 2 courses ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	February 2006
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dosing Schedule 1 Starting dose of 25 mg, with dosing twice a week for 3 weeks out of a 4-week course (Schedule 1).	Drug: CNF2024 CNF2024 capsules administered orally following 2 schedules: starting dose of 25 mg, twice a week for 3 weeks out of a 4-week course (Schedule 1) or starting dose of 600 mg twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation proceeds according to the predetermined scheme until the stopping dose is reached due to a dose limiting toxicity (DLT) occurring during the first 4-week course of treatment.
Dosing Schedule 2 Starting dose of 600 mg, with dosing twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2).	Drug: CNF2024 CNF2024 capsules administered orally following 2 schedules: starting dose of 25 mg, twice a week for 3 weeks out of a 4-week course (Schedule 1) or starting dose of 600 mg twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation proceeds according to the predetermined scheme until the stopping dose is reached due to a dose limiting toxicity (DLT) occurring during the first 4-week course of treatment.

Eligibility

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed solid tumor which has failed standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy) or for which effective therapy is not available
Absolute neutrophil count (ANC) > 1500 cells/mm3, platelet count > 100,000 cells/mm3 and hemoglobin >= 9 gm/L
Bilirubin < 1.5 X upper limit of normal (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 X ULN. Patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5.0 X ULN.
Serum creatinine < 2.0 mg/dL or creatinine clearance > 60 mL/min
Coagulation: international normalized ratio (INR) < 1.5 times normal
Normal plasma cortisol and adrenocorticotropic hormone (ACTH) levels
Normal electrocardiogram (ECG) with QTc <= 450 msec for men and <= 470 msec for women
Estimated life expectancy >= 3 months
ECOG performance status <= 2
For men and women of child-producing potential, use of effective contraceptive methods during the study
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments

Exclusion Criteria:

Pregnant or nursing women
Radiotherapy or chemotherapy within the previous 28 days. Recovery to Grade 1 or less from chemotherapy-induced toxic effect, except alopecia, is required.
Participation in any investigational drug study within 28 days prior to CNF2024 administration
Active infection requiring intravenous antibiotic treatment
Patients with second malignancy requiring active treatment (except hormonal therapy)
Concurrent severe or uncontrolled medical disease (i.e., systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure)
Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral (A, B or C) hepatitis
Problems with swallowing or malabsorption
Chronic diarrhea (excess of 2-3 stools/day above normal frequency)
Gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis
Major surgery of the stomach or small intestine
Adrenal dysfunction > Grade 2
Patients with diabetes (your doctor will discuss if you are eligible for this study)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345189

Contacts


Contact: Biogen Idec		oncologyclinicaltrials@biogenidec.com

Locations


United States, Arizona
	Research site	Recruiting
	Scottsdale, Arizona, United States, 85258

United States, Connecticut
	Research site	Recruiting
	New Haven, Connecticut, United States, 06520

United States, Texas
	Research site	Recruiting
	San Antonio, Texas, United States, 78245

United Kingdom, Surrey
	Research site	Not yet recruiting
	Sutton, Surrey, United Kingdom, SM2 5PT

Sponsors and Collaborators

Biogen Idec

More Information

Responsible Party:	Biogen Idec ( Biogen Idec MD )
Study ID Numbers:	CNF2024-ST-05003, 120ST101
First Received:	June 23, 2006
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00345189
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

Hsp90 inhibitor

CNF2024

Advanced Solid Tumors

Study placed in the following topic categories:

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoproliferative Disorders

Lymphoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00345189