Clinical trial · Interventional
Dose Escalation Study of MLN4924 in Adults With Melanoma
A Phase I, Open-Label, Dose Escalation Study of MLN4924, a Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients With Melanoma
NCT01011530CI-TRIAL-00011367completedPhase 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, phase 1, dose escalation study that will evaluate the safety profile, establish Maximum Tolerated Dose (MTD), and inform the recommended phase 2 dose of MLN4924 as well as evaluate antitumor activity in patients with metastatic melanoma.
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 |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MLN4924 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MLN4924
- description
- MLN4924 via IV infusion
- interventionNames
- Drug: MLN4924
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) and inform recommended phase 2 dose of MLN4924
- timeFrame
- Up to 12 months of treatment
Secondary outcomes (2)
- measure
- Anti-tumor activities of MLN4924
- timeFrame
- Up to 12 months of treatment
- measure
- Pharmacodynamic effects of MLN4924 on blood and tumor cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Each patient must meet all of the following criteria to be enrolled in the study: * Diagnosis of metastatic melanoma * Measurable disease * 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 practice effective barrier contraception or agree to abstain from heterosexual intercourse * Willing and able to give written informed consent * Suitable venous access for study-required blood sampling * Appropriate functional status, including the recovery from the effects of prior antineoplastic therapy, and acceptable organ function as described in the protocol Exclusion Criteria: Patients meeting any of the following exclusion criteria are not to be enrolled in the study: * Major surgery or, serious infections, or infections that required systematic antibiotic therapy within 14 days before the first dose of study drug * Systemic antineoplastic or radiation therapy within 14 days or treatment with any investigational products within 21 days before the first dose of study treatment * CYP3A inducers within 14 days of study treatment. Moderate and strong CYP3A inhibitors and CYP3A inducers are not permitted during the study * No prior history of amiodarone in the 6 months before the first dose of MLN4924 * Diarrhea that is greater than Grade 1 as outlined in the protocol * Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months * Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection. * Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol * Other clinical and laboratory assessments that do not meet the criteria specified in the protocol
References
Publications (1)
- DERIVEDFaessel HM, Mould DR, Zhou X, Faller DV, Sedarati F, Venkatakrishnan K. Population pharmacokinetics of pevonedistat alone or in combination with standard of care in patients with solid tumours or haematological malignancies. Br J Clin Pharmacol. 2019 Nov;85(11):2568-2579. doi: 10.1111/bcp.14078. Epub 2019 Sep 4. PMID 31355467