Clinical trial · Interventional
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
NCT00345189CI-TRIAL-00002467completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, multicenter, dose-escalation, safety, pharmacokinetics, and pharmacodynamics study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CNF2024 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Dosing Schedule 1
- description
- 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.
- interventionNames
- Drug: CNF2024
- type
- OTHER
- label
- Dosing Schedule 2
- description
- Starting dose of 600 mg, with dosing twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2).
- interventionNames
- Drug: CNF2024
Primary outcomes (5)
- measure
- To determine the maximum tolerated dose (MTD)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.