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
15 participants
INTERVENTIONAL
2009-04-30
2012-09-30
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 7 consecutive days every 14 days
Interventions
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NMS-1116354
Oral daily administration for 7 consecutive days every 14 days
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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Kyriakos Papadopoulos, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
South Texas Accelerated Research Therapeutics (START)
Bernard Laffranchi, MD
Role: STUDY_DIRECTOR
Nerviano Medical Sciences
Stefania Crippa, Biotech D, PhD
Role: STUDY_DIRECTOR
Nerviano Medical Sciences
Locations
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South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
Countries
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Other Identifiers
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CDCA-354-001
Identifier Type: -
Identifier Source: org_study_id