NCT01092052

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Last Updated

September 7, 2012

Status Verified

September 1, 2012

Enrollment Period

2.5 years

First QC Date

March 22, 2010

Last Update Submit

September 6, 2012

Conditions

Advanced/Metastatic Solid Tumors

Keywords

Phase I studyAdvanced/Metastatic Solid TumorsCdc7 kinase inhibitor

Outcome Measures

Primary Outcomes (1)

  • First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose(MTD)

    3 weeks

Secondary Outcomes (1)

  • 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

Study Arms (1)

1

EXPERIMENTAL
Drug: NMS-1116354

Interventions

NMS-1116354DRUG

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

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave-Roussy (IGR)

Villejuif, France

Location

Study Officials

  • Jean-Charles Soria, MD

    Institut Gustave-Roussy (IGR)

    PRINCIPAL INVESTIGATOR

  • Stefania Crippa, Biotech D, PhD

    Nerviano Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2010

First Posted

March 24, 2010

Study Start

January 1, 2010

Primary Completion

July 1, 2012

Last Updated

September 7, 2012

Record last verified: 2012-09

Locations

FR(1)