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Study of Oral CNF2024 (BIIB021) in Advanced Solid Tumors
This study has been completed.
Study NCT00345189   Information provided by Biogen Idec
First Received: June 23, 2006   Last Updated: July 10, 2009   History of Changes

June 23, 2006
July 10, 2009
February 2006
July 2008   (final data collection date for primary outcome measure)
  • 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 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 ]
  • To determine the maximum tolerated dose
  • pharmacokinetics
  • recommended Phase 2 dose
  • effect on pharmacodynamic biomarkers
  • anti-tumor activity
  • toxicity characteristics including the dose-limited toxicity
Complete list of historical versions of study NCT00345189 on ClinicalTrials.gov Archive Site
 
 
 
Study of Oral CNF2024 (BIIB021) in Advanced Solid Tumors
A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, PK, and PD Study of CNF2024 Administered Orally Twice Weekly for 3 Weeks of a 4 Week Course or Twice Weekly for 4 Weeks of a 4 Week Course to Patients With Advanced Solid Tumors

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

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 cycle control, and transcriptional regulation. In cancer cells that are dependent upon Hsp90 client proteins, the degree to which clients are inhibited correlates closely with induction of growth inhibition and apoptosis with Hsp90 inhibitory drugs. The active pharmaceutical ingredient of CNF2024, CF1983 mesylate, is a synthetic, new chemical entity designed to inhibit Hsp90. CF1983 hada strong affinity for tumor derived Hsp90 and weaker affinity for Hsp90 isolated from normal cells or recombinant Hsp90.

Phase I
Interventional
Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
  • Tumors
  • Lymphoma
Drug: CNF2024
  • Other: Starting dose of 25 mg, with dosing twice a week for 3 weeks out of a 4-week course (Schedule 1). Dosing for schedule 1 is currently closed.
  • Other: Starting dose of 600 mg, with dosing twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2).
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
70
April 2009
July 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00345189
Biogen Idec MD, Biogen Idec
CNF2024-ST-05003, 120ST101
Biogen Idec
 
Study Director: Biogen Idec Medical Monitor, MD Biogen Idec
Biogen Idec
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP