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A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced/Metastatic Solid Tumors

Phase 1
18 Years
80 Years
Not Enrolling
Advanced/Metastatic Solid Tumors

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Trial Information

A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced/Metastatic Solid Tumors

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

5. ECOG performance status (PS) 0 or 1

6. Adult (age >/= 18 and
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

6. Pregnancy or breast-feeding women

7. Known active infections

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

9. Adrenal insufficiency

10. Other severe 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:

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

Outcome Time Frame:

3 weeks

Safety Issue:


Principal Investigator

Jean-Charles Soria, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Gustave-Roussy (IGR)


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

January 2010

Completion Date:

Related Keywords:

  • Advanced/Metastatic Solid Tumors
  • Phase I study
  • Advanced/Metastatic Solid Tumors
  • Cdc7 kinase inhibitor
  • Neoplasms