A Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial
A Phase II Open-label Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial
2 other identifiers
interventional
13
7 countries
12
Brief Summary
The purpose of this study is to provide access to continued treatment for subjects who participated in other Astellas sponsored trials and for whom the investigator feels the subject may benefit from continued treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2014
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2014
CompletedFirst Posted
Study publicly available on registry
February 7, 2014
CompletedStudy Start
First participant enrolled
April 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2016
CompletedNovember 20, 2024
November 1, 2024
2.5 years
February 5, 2014
November 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with adverse events
24 months
Study Arms (12)
Arm A: High dose linsitinib twice daily monotherapy
EXPERIMENTALArm A includes subjects from Protocol OSI-906-301
Arm B: High dose linsitinib BID plus high dose erlotinib QD
EXPERIMENTALArm B includes subjects from Protocol OSI-906-205
Arm C: High dose erlotinib monotherapy once daily
EXPERIMENTALArm C includes subjects from Protocol OSI-906-205 and OSI-906-207
Arm D: High dose linsitinib BID plus weekly paclitaxel
EXPERIMENTALArm D includes subjects from Protocol OSI-906-202
Arm E: Highest dose linsitinib intermittent once daily
EXPERIMENTALArm E includes subjects from Protocol OSI-906-202, linsitinib on Days 1-3 of each week plus weekly paclitaxel
Arm F: Paclitaxel alone weekly
EXPERIMENTALArm F includes subjects from Protocol OSI-906-202
Arm G: Lowest dose linsitinib twice daily + low dose erlotinib
EXPERIMENTALArm G includes subjects from Protocol OSI-906-103
Arm H: high dose linsitinib twice daily
EXPERIMENTALincludes subjects from protocols SARC 022/CTEP 8945, linsitinib x28 days (each cycle)
Arm I: highest dose linsitinib once daily
EXPERIMENTALincludes subjects from EuroSARC protocol, linsitinib on Days 1-3; Days 8-10 and Days 15-17
Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone
EXPERIMENTALincludes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone
EXPERIMENTALincludes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone
EXPERIMENTALincludes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
Interventions
oral
oral
Intravenous (IV) infusion
Subcutaneous or IV
IV, Oral
Eligibility Criteria
You may qualify if:
- Subject must currently be participating in an Astellas sponsored linsitinib trial that has ended with respect to the overall study analysis.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Site US10004
La Jolla, California, 92093-0987, United States
Site US10006
Tampa, Florida, 33612, United States
Site US10002
Baltimore, Maryland, 21287, United States
Site US10008
Ann Arbor, Michigan, 48109, United States
Site US10001
Oklahoma City, Oklahoma, 73104, United States
Site BR55005
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Site CZ42001
Ostrava-Poruba, 70852, Czechia
Site DE49002
Berlin, 10117, Germany
Site DE49001
Würzburg, 97080, Germany
Site PL48001
Szczecin, West Pomeranian Voivodeship, 70-891, Poland
Site SG65002
Singapore, 308433, Singapore
Site TH66003
Khon Kaen, 40002, Thailand
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Executive Medical Director
Astellas Pharma Global Development, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2014
First Posted
February 7, 2014
Study Start
April 16, 2014
Primary Completion
October 14, 2016
Study Completion
December 21, 2016
Last Updated
November 20, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.