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

November 15, 2024 updated by: Astellas Pharma Global Development, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Site BR55005
  • Czechia
      • Ostrava-Poruba, Czechia, 70852
        • Site CZ42001
  • Germany
      • Berlin, Germany, 10117
        • Site DE49002
      • Wuerzburg, Germany, 97080
        • Site DE49001
  • Poland
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 70-891
        • Site PL48001
  • Singapore
      • Singapore, Singapore, 308433
        • Site SG65002
  • Thailand
      • Khon Kaen, Thailand, 40002
        • Site TH66003
  • United States
    • California
      • La Jolla, California, United States, 92093-0987
        • Site US10004
    • Florida
      • Tampa, Florida, United States, 33612
        • Site US10006
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Site US10002
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Site US10008
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Site US10001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • OSI-906
Experimental: Arm B: High dose linsitinib BID plus high dose erlotinib QD
Arm B includes subjects from Protocol OSI-906-205
Drug: erlotinib
oral
Other Names:
  • Tarceva
  • OSI-774
Drug: linsitinib
oral
Other Names:
  • OSI-906
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:
  • Tarceva
  • OSI-774
Experimental: Arm D: High dose linsitinib BID plus weekly paclitaxel
Arm D includes subjects from Protocol OSI-906-202
Drug: linsitinib
oral
Other Names:
  • 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 Names:
  • 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: erlotinib
oral
Other Names:
  • Tarceva
  • OSI-774
Drug: linsitinib
oral
Other Names:
  • OSI-906
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 Names:
  • 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 Names:
  • 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 Names:
  • OSI-906
Drug: Bortezomib
Subcutaneous or IV
Other Names:
  • Velcade
Drug: Dexamethasone
IV, Oral
Other Names:
  • Decadron
  • Baycadron
  • Ozurdex
  • Maxidex
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 Names:
  • OSI-906
Drug: Bortezomib
Subcutaneous or IV
Other Names:
  • Velcade
Drug: Dexamethasone
IV, Oral
Other Names:
  • Decadron
  • Baycadron
  • Ozurdex
  • Maxidex
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 Names:
  • OSI-906
Drug: Bortezomib
Subcutaneous or IV
Other Names:
  • Velcade
Drug: Dexamethasone
IV, Oral
Other Names:
  • Decadron
  • Baycadron
  • Ozurdex
  • Maxidex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with adverse events
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Global Development, Inc.

Investigators

  • Study Director: Executive Medical Director, Astellas Pharma Global Development, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2014

Primary Completion (Actual)

October 14, 2016

Study Completion (Actual)

December 21, 2016

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

February 5, 2014

First Posted (Estimated)

February 7, 2014

Study Record Updates

Last Update Posted (Actual)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7487-CL-0209
  • 2013-004076-34 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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/.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe