A Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial
NCT ID: NCT02057380
Last Updated: 2024-11-20
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
PHASE2
13 participants
INTERVENTIONAL
2014-04-16
2016-12-21
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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Arm A: High dose linsitinib twice daily monotherapy
Arm A includes subjects from Protocol OSI-906-301
linsitinib
oral
Arm B: High dose linsitinib BID plus high dose erlotinib QD
Arm B includes subjects from Protocol OSI-906-205
linsitinib
oral
erlotinib
oral
Arm C: High dose erlotinib monotherapy once daily
Arm C includes subjects from Protocol OSI-906-205 and OSI-906-207
erlotinib
oral
Arm D: High dose linsitinib BID plus weekly paclitaxel
Arm D includes subjects from Protocol OSI-906-202
linsitinib
oral
paclitaxel
Intravenous (IV) infusion
Arm E: Highest dose linsitinib intermittent once daily
Arm E includes subjects from Protocol OSI-906-202, linsitinib on Days 1-3 of each week plus weekly paclitaxel
linsitinib
oral
paclitaxel
Intravenous (IV) infusion
Arm F: Paclitaxel alone weekly
Arm F includes subjects from Protocol OSI-906-202
paclitaxel
Intravenous (IV) infusion
Arm G: Lowest dose linsitinib twice daily + low dose erlotinib
Arm G includes subjects from Protocol OSI-906-103
linsitinib
oral
erlotinib
oral
Arm H: high dose linsitinib twice daily
includes subjects from protocols SARC 022/CTEP 8945, linsitinib x28 days (each cycle)
linsitinib
oral
Arm I: highest dose linsitinib once daily
includes subjects from EuroSARC protocol, linsitinib on Days 1-3; Days 8-10 and Days 15-17
linsitinib
oral
Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone
includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
linsitinib
oral
Bortezomib
Subcutaneous or IV
Dexamethasone
IV, Oral
Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone
includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
linsitinib
oral
Bortezomib
Subcutaneous or IV
Dexamethasone
IV, Oral
Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone
includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
linsitinib
oral
Bortezomib
Subcutaneous or IV
Dexamethasone
IV, Oral
Interventions
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linsitinib
oral
erlotinib
oral
paclitaxel
Intravenous (IV) infusion
Bortezomib
Subcutaneous or IV
Dexamethasone
IV, Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject must not have met criteria for discontinuation or have progressed on the current linsitinib study in which they are participating.
* Subject must be deriving benefit from continued treatment.
18 Years
ALL
No
Sponsors
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Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Executive Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development, Inc.
Locations
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Site US10004
La Jolla, California, United States
Site US10006
Tampa, Florida, United States
Site US10002
Baltimore, Maryland, United States
Site US10008
Ann Arbor, Michigan, United States
Site US10001
Oklahoma City, Oklahoma, United States
Site BR55005
Porto Alegre, Rio Grande do Sul, Brazil
Site CZ42001
Ostrava-Poruba, , Czechia
Site DE49002
Berlin, , Germany
Site DE49001
Würzburg, , Germany
Site PL48001
Szczecin, West Pomeranian Voivodeship, Poland
Site SG65002
Singapore, , Singapore
Site TH66003
Khon Kaen, , Thailand
Countries
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Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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2013-004076-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7487-CL-0209
Identifier Type: -
Identifier Source: org_study_id
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