- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01092052
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
Conditions
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:
- 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
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.
Sponsor
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.
Clinical Trials on Advanced/Metastatic Solid Tumors
-
Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
-
Memorial Sloan Kettering Cancer CenterKyowa Hakko Kirin Pharma, Inc.CompletedAdvanced Solid Tumors | Metastatic Solid TumorsUnited States
-
Bristol-Myers SquibbCompletedAdvanced Solid Tumors | Metastatic Solid TumorsKorea, Republic of, Canada, Australia
-
Incyte CorporationRecruitingA Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors | Solid Tumors | Metastatic Solid TumorsUnited States, Spain, United Kingdom, France, Italy, Denmark, Switzerland
-
Genentech, Inc.RecruitingAdvanced Solid Tumors | Metastatic Solid TumorsCanada, Korea, Republic of, United States, Brazil, Australia, Argentina, Spain, New Zealand, Poland
-
NeuPharma, Inc.RecruitingLocally Advanced Solid Tumors | Metastatic Solid TumorsUnited States
-
Alphamab (Australia) Co Pty Ltd.RecruitingAdvanced Solid Tumors | Metastatic Solid TumorsAustralia
-
Jiangsu Simcere Pharmaceutical Co., Ltd.UnknownAdvanced Solid Tumors | Metastatic Solid TumorsChina
-
University of AlbertaWithdrawnLocally Advanced Solid Tumors | Metastatic Solid TumorsCanada
-
OBI Pharma, IncTerminatedLocally Advanced Solid Tumors | Metastatic Solid TumorsUnited States, Taiwan
Clinical Trials on NMS-1116354
-
Nerviano Medical SciencesTerminated
-
Nerviano Medical SciencesCompletedAdvanced or Metastatic Solid TumorsUnited States
-
Nerviano Medical SciencesActive, not recruitingUnresectable Hepatocellular Carcinoma (HCC)Italy, Spain, United States
-
Samuel Lunenfeld Research Institute, Mount Sinai...Terminated
-
Magnus MedicalRecruiting
-
Nerviano Medical SciencesRecruitingAdvanced/Metastatic Solid TumorsUnited States, China, Italy
-
Nerviano Medical SciencesRecruitingAcute Myeloid Leukemia (AML) | Chronic Myelomonocytic Leukemia (CMML)Italy, Spain, France
-
Sahlgrenska University Hospital, SwedenCompletedParkinson DiseaseSweden
-
Nerviano Medical SciencesRecruitingMultiple MyelomaUnited States, Italy