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Study of NMS-1116354 in Solid Tumors

This study has been terminated.
(Discontinuation of clinical investigation with NMS-1116354)
Sponsor:
Information provided by (Responsible Party):
Nerviano Medical Sciences
ClinicalTrials.gov Identifier:
NCT01016327
First received: November 17, 2009
Last updated: September 6, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced solid tumors.


Condition Intervention Phase
Advanced Solid Tumors
 Drug: NMS-1116354
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Nerviano Medical Sciences:

Primary Outcome Measures:
  • First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose (MTD) [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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: Cycles 1 and 2 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: April 2009
Study Completion Date: September 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: NMS-1116354
Oral daily administration for 7 consecutive days every 14 days

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016327

Locations
United States, Texas
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Nerviano Medical Sciences
Investigators
Principal Investigator: Kyriakos Papadopoulos, MD, MSc South Texas Accelerated Research Therapeutics (START)
Study Director: Bernard Laffranchi, MD Nerviano Medical Sciences
Study Director: Stefania Crippa, Biotech D, PhD Nerviano Medical Sciences
  More Information

No publications provided

Responsible Party: Nerviano Medical Sciences
ClinicalTrials.gov Identifier: NCT01016327     History of Changes
Other Study ID Numbers: CDCA-354-001
Study First Received: November 17, 2009
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nerviano Medical Sciences:
Phase I study
Advanced Solid Tumors
Cdc7 kinase inhibitor

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013