Study of NMS-1116354 in Advanced/Metastatic Solid Tumors

Sponsor

Nerviano Medical Sciences (Industry)

Overall Status

Terminated

CT.gov ID

NCT01092052

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced/Metastatic Solid Tumors	Drug: NMS-1116354	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: NMS-1116354 Oral daily administration for 14 consecutive days followed by 7 days of rest

Arm

Intervention/Treatment

Experimental: 1

Drug: NMS-1116354

Oral daily administration for 14 consecutive days followed by 7 days of rest

Outcome Measures

Primary Outcome Measures

First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose(MTD) [3 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 </= 80 years) patients
Adequate renal, liver and BM reserve
Capability to swallow capsules intact

Exclusion Criteria:

Current enrollment in another therapeutic clinical trial
Known brain metastases
Currently active second malignancy
Major surgery within 4 weeks prior to treatment
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
Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption
Adrenal insufficiency
Other severe acute or chronic medical or psychiatric condition that could compromise protocol objectives

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Gustave-Roussy (IGR)	Villejuif, Cedex		France

Sponsors and Collaborators

Nerviano Medical Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nerviano Medical Sciences

ClinicalTrials.gov Identifier:

NCT01092052

Other Study ID Numbers:

CDCA-354-002

First Posted:

Mar 24, 2010

Last Update Posted:

Sep 7, 2012

Last Verified:

Sep 1, 2012

Keywords provided by Nerviano Medical Sciences

Phase I study

Advanced/Metastatic Solid Tumors

Cdc7 kinase inhibitor

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Sep 7, 2012