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

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
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: linsitinib Drug: erlotinib Drug: paclitaxel Drug: Bortezomib Drug: Dexamethasone Phase 2

Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: High dose linsitinib twice daily monotherapy
Arm A includes subjects from Protocol OSI-906-301
 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:
  • OSI-774
  • Tarceva
Experimental: Arm C: High dose erlotinib monotherapy once daily
Arm C includes subjects from Protocol OSI-906-205 and OSI-906-207
 Drug: erlotinib
oral
Other Names:
  • OSI-774
  • Tarceva
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:
  • OSI-774
  • Tarceva
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:
  • Maxidex
  • Baycadron
  • Ozurdex
  • Decadron
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:
  • Maxidex
  • Baycadron
  • Ozurdex
  • Decadron
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:
  • Maxidex
  • Baycadron
  • Ozurdex
  • Decadron


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: 24 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
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Study Director: Executive Medical Director Astellas Pharma Global Development, Inc.
More Information
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Additional Information:

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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."
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
Paclitaxel
Linsitinib
OSI-774
Advanced Solid Tumor
 Tarceva
Erlotinib
OSI-906
Additional relevant MeSH terms:
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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