Working… Menu

Study of NMS-1116354 in Advanced/Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01092052
Recruitment Status : Terminated (Discontinuation of clinical investigation with NMS-1116354)
First Posted : March 24, 2010
Last Update Posted : September 7, 2012
Information provided by (Responsible Party):
Nerviano Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Advanced/Metastatic Solid Tumors Drug: NMS-1116354 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced/Metastatic Solid Tumors
Study Start Date : January 2010
Actual Primary Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: NMS-1116354
Oral daily administration for 14 consecutive days followed by 7 days of rest

Primary Outcome Measures :
  1. First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose(MTD) [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  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) [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01092052

Layout table for location information
Institut Gustave-Roussy (IGR)
Villejuif, Cedex, France
Sponsors and Collaborators
Nerviano Medical Sciences
Layout table for investigator information
Principal Investigator: Jean-Charles Soria, MD Institut Gustave-Roussy (IGR)
Study Director: Stefania Crippa, Biotech D, PhD Nerviano Medical Sciences

Layout table for additonal information
Responsible Party: Nerviano Medical Sciences Identifier: NCT01092052     History of Changes
Other Study ID Numbers: CDCA-354-002
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: September 2012
Keywords provided by Nerviano Medical Sciences:
Phase I study
Advanced/Metastatic Solid Tumors
Cdc7 kinase inhibitor
Additional relevant MeSH terms:
Layout table for MeSH terms