Study of NMS-1116354 in Advanced/Metastatic Solid Tumors

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

NCT01092052•Nerviano Medical Sciences

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Institut Gustave-Roussy (IGR)

Villejuif, France

Key Dates

Start Date

January 1, 2010

Primary Completion Date

July 1, 2012

Last Updated

September 7, 2012

Enrollment

ACTUAL participants

Conditions

Advanced/Metastatic Solid Tumors

Interventions

NMS-1116354

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 7, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of NMS-1116354 in Advanced/Metastatic Solid Tumors

Inclusion Criteria

Exclusion Criteria

A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (a KAT6A/B Inhibitor) in Patients With Advanced/Metastatic Solid Tumor

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and PK of HLX48 in Advanced/Metastatic Solid Tumors

HY-0102 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumours