Status:
COMPLETED
Study of Oral CNF2024 (BIIB021) in Advanced Solid Tumors
Lead Sponsor:
Biogen
Conditions:
Tumors
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, multicenter, dose-escalation, safety, pharmacokinetics, and pharmacodynamics study.
Detailed Description
Heat shock protein 90 (Hsp90) is an ubiquitous molecular chaperone protein that is involved in folding, activation, and assembly of many proteins, including key mediators of signal transduction, cell ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed solid tumor which has failed standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy) or for which effective therapy is not available
- At least 18 years of age
- Hematology: Absolute neutrophil count (ANC) \> 1500 cells/mm3, platelet count \> 100,000 cells/mm3 and hemoglobin \>= 9 gm/L
- Hepatic: 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.
- Renal: Serum creatinine levels \< 2.0 mg/dL or creatinine clearance \> 60 mL/min
- Coagulation: international normalized ratio (INR) \< 1.5 times normal
- Adrenal: 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 of at least 3 months as determined by the Investigator
- Eastern Cooperative Oncology Group (ECOG) performance status \<= 2
- Male and female patients of childbearing potential must practice effective double-barrier contraception during the study and continue contraception for 3 months after their last dose of study drug. Male patients must agree to not have intercourse with pregnant or nursing women during the study and for 3 months after their last dose of study drug, unless using double-barrier contraception. The only exceptions to double-barrier contraception are: Patient or partner is surgically sterile,female patient is postmenopausal for at least 1 year before screening or patient abstains from sexual intercourse, at the discretion of the Investigator
Exclusion
- Pregnant or nursing women, women of child-bearing age not using reliable means of contraception.
- 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)
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00345189
Start Date
February 1 2006
End Date
April 1 2009
Last Update
July 14 2009
Active Locations (4)
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1
Research site
Scottsdale, Arizona, United States, 85258
2
Research site
New Haven, Connecticut, United States, 06520
3
Research site
San Antonio, Texas, United States, 78245
4
Research site
Sutton, Surrey, United Kingdom, SM2 5PT