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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02057380

Enrollment

Registered

2014-02-07

Start date

2014-04-16

Completion date

2016-12-21

Last updated

2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Keywords

Paclitaxel, Linsitinib, OSI-774, Advanced Solid Tumor, Tarceva, Erlotinib, OSI-906

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.

Interventions

DRUGlinsitinib

oral

DRUGerlotinib

oral

DRUGpaclitaxel

Intravenous (IV) infusion

DRUGBortezomib

Subcutaneous or IV

DRUGDexamethasone

IV, Oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Number of subjects with adverse events	24 months

Countries

Brazil, Czechia, Germany, Poland, Singapore, Thailand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026