Study of NMS-1116354 in Advanced/Metastatic Solid Tumors
NCT ID: NCT01092052
Last Updated: 2012-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
24 participants
INTERVENTIONAL
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
NMS-1116354
Oral daily administration for 14 consecutive days followed by 7 days of rest
Interventions
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NMS-1116354
Oral daily administration for 14 consecutive days followed by 7 days of rest
Eligibility Criteria
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Inclusion Criteria
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 therapy
5. ECOG performance status (PS) 0 or 1
6. Adult (age \>/= 18 and \</= 80 years) patients
7. Adequate renal, liver and BM reserve
8. Capability to swallow capsules intact
Exclusion Criteria
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 thrombosis
6. Pregnancy or breast-feeding women
7. Known active infections
8. Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption
9. Adrenal insufficiency
10. Other severe acute or chronic medical or psychiatric condition that could compromise protocol objectives
18 Years
80 Years
ALL
No
Sponsors
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Nerviano Medical Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Charles Soria, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Gustave-Roussy (IGR)
Stefania Crippa, Biotech D, PhD
Role: STUDY_DIRECTOR
Nerviano Medical Sciences
Locations
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Institut Gustave-Roussy (IGR)
Villejuif, , France
Countries
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Other Identifiers
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CDCA-354-002
Identifier Type: -
Identifier Source: org_study_id