A Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Open-label Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: linsitinib
* Drug: erlotinib
* Drug: paclitaxel
* Drug: Bortezomib
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: High dose linsitinib twice daily monotherapy<br>Arm A includes subjects from Protocol OSI-906-301 | Drug: linsitinib<br>* oral<br>* Other names: OSI-906;|
| Experimental: Arm B: High dose linsitinib BID plus high dose erlotinib QD<br>Arm B includes subjects from Protocol OSI-906-205 | Drug: linsitinib<br>* oral<br>* Other names: OSI-906;Drug: erlotinib<br>* oral<br>* Other names: Tarceva;|
| Experimental: Arm C: High dose erlotinib monotherapy once daily<br>Arm C includes subjects from Protocol OSI-906-205 and OSI-906-207 | Drug: erlotinib<br>* oral<br>* Other names: Tarceva;|
| Experimental: Arm D: High dose linsitinib BID plus weekly paclitaxel<br>Arm D includes subjects from Protocol OSI-906-202 | Drug: linsitinib<br>* oral<br>* Other names: OSI-906;Drug: paclitaxel<br>* Intravenous (IV) infusion<br>|
| Experimental: Arm E: Highest dose linsitinib intermittent once daily<br>Arm E includes subjects from Protocol OSI-906-202, linsitinib on Days 1-3 of each week plus weekly paclitaxel | Drug: linsitinib<br>* oral<br>* Other names: OSI-906;Drug: paclitaxel<br>* Intravenous (IV) infusion<br>|
| Experimental: Arm F: Paclitaxel alone weekly<br>Arm F includes subjects from Protocol OSI-906-202 | Drug: paclitaxel<br>* Intravenous (IV) infusion<br>|
| Experimental: Arm G: Lowest dose linsitinib twice daily + low dose erlotinib<br>Arm G includes subjects from Protocol OSI-906-103 | Drug: linsitinib<br>* oral<br>* Other names: OSI-906;Drug: erlotinib<br>* oral<br>* Other names: Tarceva;|
| Experimental: Arm H: high dose linsitinib twice daily<br>includes subjects from protocols SARC 022/CTEP 8945, linsitinib x28 days (each cycle) | Drug: linsitinib<br>* oral<br>* Other names: OSI-906;|
| Experimental: Arm I: highest dose linsitinib once daily<br>includes subjects from EuroSARC protocol, linsitinib on Days 1-3; Days 8-10 and Days 15-17 | Drug: linsitinib<br>* oral<br>* Other names: OSI-906;|
| Experimental: Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone<br>includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+) | Drug: linsitinib<br>* oral<br>* Other names: OSI-906;Drug: Bortezomib<br>* Subcutaneous or IV<br>* Other names: Velcade;Drug: Dexamethasone<br>* IV, Oral<br>* Other names: Decadron;|
| Experimental: Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone<br>includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+) | Drug: linsitinib<br>* oral<br>* Other names: OSI-906;Drug: Bortezomib<br>* Subcutaneous or IV<br>* Other names: Velcade;Drug: Dexamethasone<br>* IV, Oral<br>* Other names: Decadron;|
| Experimental: Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone<br>includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+) | Drug: linsitinib<br>* oral<br>* Other names: OSI-906;Drug: Bortezomib<br>* Subcutaneous or IV<br>* Other names: Velcade;Drug: Dexamethasone<br>* IV, Oral<br>* Other names: Decadron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSI-774, Paclitaxel, Linsitinib, Advanced Solid Tumor, Tarceva, Erlotinib, OSI-906