Clinical trial · Interventional
Study of NMS-1116354 in Solid Tumors
A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced Solid Tumors
NCT01016327CI-TRIAL-00007971terminatedPhase 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): Discontinuation of clinical investigation with NMS-1116354
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced solid tumors.
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 Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NMS-1116354 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: NMS-1116354
Primary outcomes (1)
- measure
- First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose (MTD)
- timeFrame
- Cycle 1
Secondary outcomes (1)
- measure
- Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), time of occurence of Cmax (tmax) and half-life (t½)
- timeFrame
- Cycles 1 and 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Advanced/metastatic solid tumors, for which no alternative effective standard therapy is available 2. Maximum of 4 regimens of prior cancer therapy allowed 3. Prior radiotherapy allowed if no more than 25% of BM reserve irradiated 4. Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy 5. ECOG performance status (PS) 0 or 1 6. Adult (age \>/= 18 and \</= 80 years) patients 7. Adequate renal, liver and BM reserve 8. Capability to swallow capsules intact Exclusion Criteria: 1. Current enrollment in another therapeutic clinical trial 2. Known brain metastases 3. Currently active second malignancy 4. Major surgery within 4 weeks prior to treatment 5. 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 6. Pregnancy or breast-feeding women 7. Known active infections 8. Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption 9. Adrenal insufficiency 10. Other severe 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.