Study of NMS-1116354 in Advanced/Metastatic Solid Tumors | NCT01092052

Studies
Study of NMS-1116354 in Advanced/Metastatic Solid Tumors

NCT01092052

Sponsor

Nerviano Medical Sciences

Status

Terminated

Last Update Posted

Sep 7, 2012Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Advanced/Metastatic Solid Tumors

Interventions

NMS-1116354

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Discontinuation of clinical investigation with NMS-1116354

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jul 2012Actual

Completion Date

Not provided

First Submitted Date

Mar 22, 2010

First Submission Date that Met QC Criteria

Mar 22, 2010

First Posted Date

Mar 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2012

Last Update Posted Date

Sep 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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/metastatic solid tumors.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: NMS-1116354

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NMS-1116354	Drug	Oral daily administration for 14 consecutive days followed by 7 days of rest	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose(MTD)		3 weeks

Secondary Outcomes

Measure	Description	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)		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced/metastatic solid tumors, for which no alternative effective standard therapy is available
Maximum of 4 regimens of prior cancer therapy allowed
Prior radiotherapy allowed if no more than 25% of BM reserve irradiated
Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy
ECOG performance status (PS) 0 or 1
Adult (age >/= 18 and \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Charles Soria, MD	Institut Gustave-Roussy (IGR)	Principal Investigator
Stefania Crippa, Biotech D, PhD	Nerviano Medical Sciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave-Roussy (IGR)		Villejuif			France