A Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02057380 |
Recruitment Status :
Completed
First Posted : February 7, 2014
Last Update Posted : September 4, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumors | Drug: linsitinib Drug: erlotinib Drug: paclitaxel Drug: Bortezomib Drug: Dexamethasone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Open-label Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial |
Actual Study Start Date : | April 16, 2014 |
Actual Primary Completion Date : | October 14, 2016 |
Actual Study Completion Date : | December 21, 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm A: High dose linsitinib twice daily monotherapy
Arm A includes subjects from Protocol OSI-906-301
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Drug: linsitinib
oral
Other Name: OSI-906 |
Experimental: Arm B: High dose linsitinib BID plus high dose erlotinib QD
Arm B includes subjects from Protocol OSI-906-205
|
Drug: linsitinib
oral
Other Name: OSI-906 Drug: erlotinib oral
Other Names:
|
Experimental: Arm C: High dose erlotinib monotherapy once daily
Arm C includes subjects from Protocol OSI-906-205 and OSI-906-207
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Drug: erlotinib
oral
Other Names:
|
Experimental: Arm D: High dose linsitinib BID plus weekly paclitaxel
Arm D includes subjects from Protocol OSI-906-202
|
Drug: linsitinib
oral
Other Name: OSI-906 Drug: paclitaxel Intravenous (IV) infusion |
Experimental: 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
|
Drug: linsitinib
oral
Other Name: OSI-906 Drug: paclitaxel Intravenous (IV) infusion |
Experimental: Arm F: Paclitaxel alone weekly
Arm F includes subjects from Protocol OSI-906-202
|
Drug: paclitaxel
Intravenous (IV) infusion |
Experimental: Arm G: Lowest dose linsitinib twice daily + low dose erlotinib
Arm G includes subjects from Protocol OSI-906-103
|
Drug: linsitinib
oral
Other Name: OSI-906 Drug: erlotinib oral
Other Names:
|
Experimental: Arm H: high dose linsitinib twice daily
includes subjects from protocols SARC 022/CTEP 8945, linsitinib x28 days (each cycle)
|
Drug: linsitinib
oral
Other Name: OSI-906 |
Experimental: Arm I: highest dose linsitinib once daily
includes subjects from EuroSARC protocol, linsitinib on Days 1-3; Days 8-10 and Days 15-17
|
Drug: linsitinib
oral
Other Name: OSI-906 |
Experimental: 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+)
|
Drug: linsitinib
oral
Other Name: OSI-906 Drug: Bortezomib Subcutaneous or IV
Other Name: Velcade Drug: Dexamethasone IV, Oral
Other Names:
|
Experimental: 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+)
|
Drug: linsitinib
oral
Other Name: OSI-906 Drug: Bortezomib Subcutaneous or IV
Other Name: Velcade Drug: Dexamethasone IV, Oral
Other Names:
|
Experimental: 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+)
|
Drug: linsitinib
oral
Other Name: OSI-906 Drug: Bortezomib Subcutaneous or IV
Other Name: Velcade Drug: Dexamethasone IV, Oral
Other Names:
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- Number of subjects with adverse events [ Time Frame: 24 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057380
United States, California | |
Site US10004 | |
La Jolla, California, United States, 92093-0987 | |
United States, Florida | |
Site US10006 | |
Tampa, Florida, United States, 33612 | |
United States, Maryland | |
Site US10002 | |
Baltimore, Maryland, United States, 21287 | |
United States, Michigan | |
Site US10008 | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Oklahoma | |
Site US10001 | |
Oklahoma City, Oklahoma, United States, 73104 | |
Brazil | |
Site BR55005 | |
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000 | |
Czechia | |
Site CZ42001 | |
Ostrava-Poruba, Czechia, 70852 | |
Germany | |
Site DE49002 | |
Berlin, Germany, 10117 | |
Site DE49001 | |
Wuerzburg, Germany, 97080 | |
Poland | |
Site PL48001 | |
Szczecin, Zachodniopomorskie, Poland, 70-891 | |
Singapore | |
Site SG65002 | |
Singapore, Singapore, 308433 | |
Thailand | |
Site TH66003 | |
Khon Kaen, Thailand, 40002 |
Study Director: | Executive Medical Director | Astellas Pharma Global Development, Inc. |
Responsible Party: | Astellas Pharma Global Development, Inc. |
ClinicalTrials.gov Identifier: | NCT02057380 |
Other Study ID Numbers: |
7487-CL-0209 2013-004076-34 ( EudraCT Number ) |
First Posted: | February 7, 2014 Key Record Dates |
Last Update Posted: | September 4, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas." |
Paclitaxel Linsitinib OSI-774 Advanced Solid Tumor |
Tarceva Erlotinib OSI-906 |
Dexamethasone Paclitaxel Erlotinib Hydrochloride Bortezomib Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Protein Kinase Inhibitors Enzyme Inhibitors |