Study of NMS-1116354 in Solid Tumors

NCT01016327 | Terminated Phase 1

• 1 other identifier: CDCA-354-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 solid tumors.

Conditions

Advanced Solid Tumors

Keywords

Phase I study; Advanced Solid Tumors; Cdc7 kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose (MTD)

  Cycle 1

Secondary Outcomes (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)

  Cycles 1 and 2

Study Arms (1)

1

EXPERIMENTAL

Drug: NMS-1116354

Interventions

NMS-1116354 DRUG

Oral daily administration for 7 consecutive days every 14 days

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nerviano Medical Sciences: lead

Study Sites (1)

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229, United States

Location

Study Officials

• Kyriakos Papadopoulos, MD, MSc

  South Texas Accelerated Research Therapeutics (START)

  PRINCIPAL INVESTIGATOR

• Bernard Laffranchi, MD

  Nerviano Medical Sciences

  STUDY DIRECTOR

• Stefania Crippa, Biotech D, PhD

  Nerviano Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 19, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2012
• Last Updated: September 7, 2012

Record last verified: 2012-09

Locations

US (1)