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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004076-34 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: High dose linsitinib twice daily monotherapy | Experimental | Arm A includes subjects from Protocol OSI-906-301 |
|
| Arm B: High dose linsitinib BID plus high dose erlotinib QD | Experimental | Arm B includes subjects from Protocol OSI-906-205 |
|
| Arm C: High dose erlotinib monotherapy once daily | Experimental | Arm C includes subjects from Protocol OSI-906-205 and OSI-906-207 |
|
| Arm D: High dose linsitinib BID plus weekly paclitaxel | Experimental | Arm D includes subjects from Protocol OSI-906-202 |
|
| Arm E: Highest dose linsitinib intermittent once daily | Experimental | Arm E includes subjects from Protocol OSI-906-202, linsitinib on Days 1-3 of each week plus weekly paclitaxel |
|
| Arm F: Paclitaxel alone weekly |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linsitinib | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | 24 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Executive Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site US10004 | La Jolla | California | 92093-0987 | United States | ||
| Site US10006 |
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| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website | View source |
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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/.
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| Experimental |
Arm F includes subjects from Protocol OSI-906-202 |
|
| Arm G: Lowest dose linsitinib twice daily + low dose erlotinib | Experimental | Arm G includes subjects from Protocol OSI-906-103 |
|
| Arm H: high dose linsitinib twice daily | Experimental | includes subjects from protocols SARC 022/CTEP 8945, linsitinib x28 days (each cycle) |
|
| Arm I: highest dose linsitinib once daily | Experimental | includes 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 | Experimental | includes 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 | Experimental | includes 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 | Experimental | includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+) |
|
|
| erlotinib | Drug | oral |
|
|
| paclitaxel | Drug | Intravenous (IV) infusion |
|
| Bortezomib | Drug | Subcutaneous or IV |
|
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| Dexamethasone | Drug | IV, Oral |
|
|
| 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 |
| ID | Term |
|---|---|
| C551528 | 3-(8-amino-1-(2-phenylquinolin-7-yl)imidazo(1,5-a)pyrazin-3-yl)-1-methylcyclobutanol |
| D000069347 | Erlotinib Hydrochloride |
| D017239 | Paclitaxel |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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