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Trial record 2 of 2 for:    OSI-906-207

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT02057380
First received: February 5, 2014
Last updated: October 13, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Advanced Solid Tumors
Drug: linsitinib
Drug: erlotinib
Drug: paclitaxel
Drug: Bortezomib
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Number of subjects with adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: April 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057380

Locations
United States, California
Site US10004
La Jolla, California, United States, 92093
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
Czech Republic
Site CZ42001
Ostrava-Poruba, Czech Republic, 70852
Germany
Site DE49002
Berlin, Germany, 10117
Site DE49001
Würzburg, Germany, 97080
Poland
Site PL48001
Sokolowsko, Poland, 70-891
Singapore
Site SG65002
Jalan Tan Tock Seng, Singapore, 308433
Thailand
Site TH66003
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
Study Director: Executive Medical Director Astellas Pharma Global Development, Inc.
  More Information

Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT02057380     History of Changes
Other Study ID Numbers: 7487-CL-0209  2013-004076-34 
Study First Received: February 5, 2014
Last Updated: October 13, 2016
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Germany: Federal Institute for Drugs and Medical Devices
Singapore: Health Sciences Authority
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Brazil: National Health Surveillance Agency
United States: Food and Drug Administration
Thailand: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
Paclitaxel
Linsitinib
OSI-774
Advanced Solid Tumor
Tarceva
Erlotinib
OSI-906

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Paclitaxel
Albumin-Bound Paclitaxel
Erlotinib Hydrochloride
Bortezomib
BB 1101
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
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on December 08, 2016