Clinical trial · Interventional
Phase 1, Dose-Escalation Study of Oral CNF2024(BIIB021) in CLL
A Phase 1, Dose-Escalation Study of CNF2024 Administered Orally to Patients With B Cell Chronic Lymphocytic Leukemia (CLL)
NCT00344786CI-TRIAL-00002369terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor's decision
Summary
Brief summary (as posted)
CLL dosing escalating study; daily dosing schedule; PK/PD safety
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-Cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CNF2024 (BIIB021) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CNF2024
- interventionNames
- Drug: CNF2024 (BIIB021)
Primary outcomes (3)
- measure
- Safety and toxicity (maximum tolerated dose (MTD))
- timeFrame
- 4 week periods until MTD is reached
- measure
- Pharmacokinetics
- timeFrame
- Dosing period
- measure
- Pharmacodynamics
- timeFrame
- Dosing period
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with CLL who relapsed following or are intolerant to purine analog -based therapy * Hemoglobin \>=9 gm/dL (may be post-transfusion) * Total bilirubin \<2 X ULN, and ALT and AST \<2 x ULN * Creatinine \<=2 X ULN * Normal plasma cortisol and ACTH concentrations * ECOG Performance Status \<=2 * Anticipated survival \>=3 months * For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after treatment * 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 return for the required assessments Exclusion Criteria: * Pregnant or nursing women * Treatment with chemotherapy, monoclonal antibody, or radiotherapy within 28 days before entering the study * Participation in any investigational drug study within 28 days before CNF2024 administration * Patients with secondary malignancy requiring active treatment (except hormonal therapy) * Active symptomatic bacterial, fungal, or viral infection including active HIV or viral (A, B, or C) hepatitis * Problems with swallowing or malabsorption * Diarrhea (excess of 2-3 stools/day above normal frequency in the past month) * Gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis * Major surgery of the stomach or small intestine * Adrenal dysfunction * Patients with life- or function-threatening CLL complications (e.g., cord compression, hemolytic crisis, urinary tract obstruction) * Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any the study's endpoints
References
Publications (0)
Data not yet available
No reference posted for this study.