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OpenTrials
Completed

NCT Number: NCT02057380

A 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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site BR55005, Porto Alegre, Rio Grande do Sul, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

linsitinib

Drug

oral

Other names: OSI-906

Erlotinib

Drug

oral

Other names: OSI-774, Tarceva

paclitaxel

Drug

Intravenous (IV) infusion

bortezomib

Drug

Subcutaneous or IV

Other names: Velcade

Dexamethasone

Drug

IV, Oral

Other names: Maxidex, Baycadron, Ozurdex, Decadron

Primary outcomes

  1. Number of subjects with adverse events

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Astellas Pharma Global Development, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 7, 2014
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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