A First-In-Human Study of RO5503781 in Participants With Advanced Malignancies Except Leukemia
NCT ID: NCT01462175
Last Updated: 2016-11-02
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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COMPLETED
PHASE1
99 participants
INTERVENTIONAL
2011-11-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Schedule A: RO5503781 QW
Participants will receive multiple ascending doses of RO5503781 orally once weekly (QW) x 3 followed by 13 days of rest in a 28 days cycle.
RO5503781
Schedule B: RO5503781 QD
Participants will receive multiple ascending doses of RO5503781 orally QD x 5 followed by 13 days of rest in a 28 days cycle.
RO5503781
Interventions
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RO5503781
Eligibility Criteria
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Inclusion Criteria
* Measurable disease (according to RECIST or Cheson criteria) or evaluable disease prior to administration of study drug
* Minimum weight of 35 kg and life expectancy of greater than or equal to (\>=) 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Acute toxicities from any prior anti-tumor therapy, surgery, or radiotherapy must have resolved to NCT-CTCAE Grade less than or equal to (\<=) 1
* Adequate renal, hepatic and bone marrow function
* Participants with stable Central Nervous System (CNS) metastasis and with chronic, stable and rate controlled atrial fibrillation
* Participants in consideration for the biomarker cohorts or apoptosis imaging cohort must consent and be able to undergo paired biopsies for tumor biomarker analyses
* Able to participate and willing to give written informed consent and to comply with the study restrictions
Exclusion Criteria
* Use of hormonal therapy within 2 weeks and use of other investigational agents or having received investigational drugs \<= 4 weeks prior to study treatment start
* History of seizure disorders or unstable CNS metastases
* Severe and/or uncontrolled cardiovascular disease or disorder
* Active (acute or chronic) or uncontrolled infection
* Pregnant or breastfeeding women
* HIV-positive participants who are currently receiving anti-retroviral treatment
* Known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
* Participants receiving oral or parenteral anticoagulants/antiplatelet agents; anticoagulant flushes for maintenance of indwelling catheters are allowed
* Participants with known bone marrow disorder which may interfere with bone marrow recovery
* Participants with hypersensitivity reaction to 18Fluorothymidine (FLT or 18F) compounds
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Melbourne, Victoria, Australia
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Bordeaux, , France
Lyon, , France
Groningen, , Netherlands
Seoul, , South Korea
Countries
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References
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Italiano A, Miller WH Jr, Blay JY, Gietema JA, Bang YJ, Mileshkin LR, Hirte HW, Higgins B, Blotner S, Nichols GL, Chen LC, Petry C, Yang QJ, Schmitt C, Jamois C, Siu LL. Phase I study of daily and weekly regimens of the orally administered MDM2 antagonist idasanutlin in patients with advanced tumors. Invest New Drugs. 2021 Dec;39(6):1587-1597. doi: 10.1007/s10637-021-01141-2. Epub 2021 Jun 28.
Other Identifiers
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2011-002767-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NP27872
Identifier Type: -
Identifier Source: org_study_id