Clinical trial · Interventional
A Study of IXAZOMIB in Adult Patients With Lymphoma
An Open-Label, Dose-Escalation, Phase 1 Study of IXAZOMIB (MLN9708), A Second-Generation Proteasome Inhibitor, in Adult Patients With Lymphoma
NCT00893464CI-TRIAL-00019761completedPhase 1Results postedClinicalTrials.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 study is an open-label, multicenter, phase 1, dose-escalation study of IXAZOMIB in adult patients with lymphoma. This study will be the first to administer IXAZOMIB to patients with lymphoma.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IXAZOMIB | Drug | Ixazomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IXAZOMIB
- interventionNames
- Drug: IXAZOMIB
Primary outcomes (5)
- measure
- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- timeFrame
- Baseline up to 30 days after last dose of study drug
- description
- An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female patients 18 years or older. 2. Eastern Cooperative Oncology Group performance status 0-2. 3. Patients must have a confirmed diagnosis of lymphoma that is relapsed and/or refractory after at least 2 prior chemotherapeutic regimens and for which no curative option exists. Patients with Waldenstrom's macroglobulinemia are not eligible for enrollment in this study. Patients with Hodgkin lymphoma are considered eligible for this study. 4. Suitable venous access for PK and pharmacodynamic evaluations. 5. Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse. Male patients who agree to to practice 2 effective methods of contraception or abstain from heterosexual intercourse. 6. Voluntary written consent must be obtained. 7. Adequate blood and chemistry values during the screening period: * Absolute neutrophil count (ANC) ≥ 1,500/mm3; platelet count ≥ 100,000/mm3. * Total bilirubin must be ≤ 1.5 × the upper limit of the normal range upper limit of normal (ULN). * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be ≤ 2.5 × the upper limit of normal (ULN). AST and ALT may be elevated up to 5 times the upper limit of normal if their elevation can be reasonably ascribed to the presence of metastatic disease. * Calculated creatinine clearance ≥ 30 mL/minute. Exclusion Criteria: 1. Peripheral neuropathy ≥ Grade 2. 2. Female patients who are lactating or have a positive serum pregnancy test during the screening period . 3. Major surgery within 14 days before the first dose of treatment. 4. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before the first dose of study treatment. 5. Life-threatening illness unrelated to cancer. 6. Diarrhea \> Grade 1 based on the NCI CTCAE categorization. 7. Systemic antineoplastic therapy/or radiotherapy within 21 days before the first dose of study treatment. 8. Systemic treatment with prohibited medications. 9. Patient has symptomatic brain metastases. 10. Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or myocardial infarction within the past 6 months. 11. QTc \> 470 milliseconds (msec) on a 12-lead electrocardiogram (ECG) obtained during the screening period. 12. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C positive. 13. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. 14. Treatment with any investigational products within 28 days before the first dose of study treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.