Clinical trial · Interventional
Study of NMS-1286937 in Adult Patients With Advanced/Metastatic Solid Tumors
A Phase I Dose Escalation Study of NMS-1286937 Administered to Adult Patients With Advanced/Metastatic Solid Tumors
NCT01014429CI-TRIAL-00007976completedPhase 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)
The purpose of this study is to evaluate the safety and tolerability of NMS-1286937, a polo-like-kinase 1 inhibitor, in patients with advanced metastatic solid tumor.
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 |
|---|---|---|---|
| Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NMS-1286937 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: NMS-1286937
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs)
- timeFrame
- Cycle 1
Secondary outcomes (2)
- measure
- Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), clearance (CL), volume of distribution, half-life (t½)
- timeFrame
- Cycles 1 and 2
- measure
- Evaluation of pharmacodynamics: biomarkers modulation in skin and/or tumor samples of consenting patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced/metastatic solid tumors, for which no effective standard therapy exist * Adult patients (age \>/= 18) * ECOG performance status (PS) 0 or 1 * Life expectancy of at least 3 months * Adequate renal, liver function and bone marrow reserve * Prior cancer therapy allowed, with max 4 regimens of chemotherapy. Washout: at least 4 wks (6 wks for nitrosoureas, mitomycin C and liposomal doxorubicin) and all toxicities recovered to CTC Grade \</=1 * Prior radiotherapy allowed if no more than 25% of BM reserve irradiated * Women and men of child producing potential should agree to use effective contraception * Capability to swallow capsules intact Exclusion Criteria: * Known uncontrolled/symptomatic brain metastases * Currently active second malignancy * Major surgery in the last 4 wks * Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis * Pregnancy or breast-feeding women * Known active infections * History of drug allergic reactions * Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption. * Documented gastrointestinal ulcer * Other severe concurrent acute or chronic medical or psychiatric condition that could compromise protocol objectives
References
Publications (0)
Data not yet available
No reference posted for this study.