Study of NMS-1116354 in Solid Tumors

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT01016327

Run by

Nerviano Medical Sciences

People needed

15

Starts

2009-04-01

Expected to finish

2012-09-01

Last updated by the study team

2012-09-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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