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

Phase 1
18 Years
Not Enrolling
Advanced or Metastatic Solid Tumors

Thank you

Trial Information

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

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

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

- 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

- Pregnancy or breast-feeding women

- Known active infections

- History of drug allergic reactions

- Gastrointestinal disease or other malabsorption syndromes that would impact on drug

- Documented gastrointestinal ulcer

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

Type of Study:


Study Design:

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

Outcome Measure:

Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs)

Outcome Time Frame:

Cycle 1

Safety Issue:


Principal Investigator

Mariangela Mariani, Biol Sci D

Investigator Role:

Study Director

Investigator Affiliation:

Nerviano Medical Sciences


United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

Related Keywords:

  • Advanced or Metastatic Solid Tumors
  • Phase I dose escalation study
  • Advanced or metastatic solid tumors
  • PLK 1 inhibitor
  • Adult patients
  • Neoplasms



Arizona TGen Clinical Research Services at Scottsdale Heathcare Scottsdale, Arizona  85258