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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Global Development, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 14, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings