Study of NMS-1116354 in Solid Tumors

Phase 1

Terminated

• Conditions: Advanced Solid Tumors
• Interventions: Drug: NMS-1116354

• Registration Number: NCT01016327
• Lead Sponsor: Nerviano Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-18
• Study First Posted: 2009-11-19
• Primary Completion: 2011-12
• Status Verified: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-06
• Last Update Posted: 2012-09-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	NMS-1116354	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

South Texas Accelerated Research Therapeutics (START); 🇺🇸 San Antonio, Texas, United States