Study of NMS-1116354 in Advanced/Metastatic Solid Tumors

September 6, 2012 updated by: Nerviano Medical Sciences

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

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.

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Villejuif, Cedex, France
        • Institut Gustave-Roussy (IGR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Oral daily administration for 14 consecutive days followed by 7 days of rest

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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)
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

March 22, 2010

First Submitted That Met QC Criteria

March 22, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

September 7, 2012

Last Update Submitted That Met QC Criteria

September 6, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDCA-354-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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