Study of NMS-1286937 in Adult Patients With Advanced/Metastatic Solid Tumors

Advanced or Metastatic Solid Tumors Clinical Trial

Official title:

A Phase I Dose Escalation Study of NMS-1286937 Administered to Adult Patients With Advanced/Metastatic Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014429
• Other study ID #: PLKA-937-001
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2009
• Last updated: September 6, 2012
• Start date: November 2009

Study information

• Verified date: September 2012
• Source: Nerviano Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of NMS-1286937, a polo-like-kinase 1 inhibitor, in patients with advanced metastatic solid tumor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Advanced/metastatic solid tumors, for which no effective standard therapy exist

• Adult patients (age >/= 18)

• ECOG performance status (PS) 0 or 1

• Life expectancy of at least 3 months

• Adequate renal, liver function and bone marrow reserve

• Prior cancer therapy allowed, with max 4 regimens of chemotherapy. Washout: at least 4 wks (6 wks for nitrosoureas, mitomycin C and liposomal doxorubicin) and all toxicities recovered to CTC Grade </=1

• Prior radiotherapy allowed if no more than 25% of BM reserve irradiated

• Women and men of child producing potential should agree to use effective contraception

• Capability to swallow capsules intact

Exclusion Criteria:

• Known uncontrolled/symptomatic brain metastases

• Currently active second malignancy

• Major surgery in the last 4 wks

• 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

• History of drug allergic reactions

• Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption.

• Documented gastrointestinal ulcer

• Other severe concurrent acute or chronic medical or psychiatric condition that could compromise protocol objectives

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumors

Intervention

Drug:
• NMS-1286937
Single Arm, dose escalation study. No. of cycles: until progression or unacceptable toxicity develops.

Locations

Country	Name	City	State
United States	Arizona TGen Clinical Research Services at Scottsdale Heathcare	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Nerviano Medical Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs)		Cycle 1	Yes
Secondary	Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), clearance (CL), volume of distribution, half-life (t½)		Cycles 1 and 2	No
Secondary	Evaluation of pharmacodynamics: biomarkers modulation in skin and/or tumor samples of consenting patients		Cycles 1 and 2	No