MedDataX Logo

Study of NMS-1286937 in Adult Patients With Advanced/Metastatic Solid Tumors

NCT ID: NCT01014429

Last Updated: 2012-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety and tolerability of NMS-1286937, a polo-like-kinase 1 inhibitor, in patients with advanced metastatic solid tumor.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced or Metastatic Solid Tumors

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Phase I dose escalation study Advanced or metastatic solid tumors PLK 1 inhibitor Adult patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

NMS-1286937

Intervention Type DRUG

Single Arm, dose escalation study. No. of cycles: until progression or unacceptable toxicity develops.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NMS-1286937

Single Arm, dose escalation study. No. of cycles: until progression or unacceptable toxicity develops.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Advanced/metastatic solid tumors, for which no effective standard therapy exist
* Adult patients (age \>/= 18)
* ECOG performance status (PS) 0 or 1
* Life expectancy of at least 3 months
* Adequate renal, liver function and bone marrow reserve
* Prior cancer therapy allowed, with max 4 regimens of chemotherapy. Washout: at least 4 wks (6 wks for nitrosoureas, mitomycin C and liposomal doxorubicin) and all toxicities recovered to CTC Grade \</=1
* Prior radiotherapy allowed if no more than 25% of BM reserve irradiated
* Women and men of child producing potential should agree to use effective contraception
* Capability to swallow capsules intact

Exclusion Criteria

* Known uncontrolled/symptomatic brain metastases
* Currently active second malignancy
* Major surgery in the last 4 wks
* 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
* History of drug allergic reactions
* Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption.
* Documented gastrointestinal ulcer
* Other severe concurrent acute or chronic medical or psychiatric condition that could compromise protocol objectives
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nerviano Medical Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mariangela Mariani, Biol Sci D

Role: STUDY_DIRECTOR

Nerviano Medical Sciences

Maria Adele Pacciarini, Biol Sci D

Role: STUDY_DIRECTOR

Nerviano Medical Sciences

Glen J Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Arizona TGen Clinical Reserch Services at Scottsdale Healthcare

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arizona TGen Clinical Research Services at Scottsdale Heathcare

Scottsdale, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PLKA-937-001

Identifier Type: -

Identifier Source: org_study_id