Study of NMS-1116354 in Solid Tumors

A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced Solid Tumors

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01016327

Enrollment

Registered

2009-11-19

Start date

2009-04-30

Completion date

2012-09-30

Last updated

2012-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Keywords

Phase I study, Advanced Solid Tumors, Cdc7 kinase inhibitor

Brief summary

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.

Interventions

DRUGNMS-1116354

Oral daily administration for 7 consecutive days every 14 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose (MTD)	Cycle 1

Secondary

Measure	Time frame
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)	Cycles 1 and 2

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026