Study of Oral CNF2024 (BIIB021) in Advanced Solid Tumors

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen

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

• 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 Criteria:

• 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)