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

Sponsor

Astellas Pharma Global Development, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02057380

Collaborator

(none)

Enrollment

Locations

Arms

32.2

Actual Duration (Months)

1.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: linsitinib Drug: erlotinib Drug: paclitaxel Drug: Bortezomib Drug: Dexamethasone	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Actual Study Start Date :

Apr 16, 2014

Actual Primary Completion Date :

Oct 14, 2016

Actual Study Completion Date :

Dec 21, 2016

Arms and Interventions

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: linsitinib oral Other Names: 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 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: linsitinib oral Other Names: 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 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: 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 Names: OSI-906 Drug: Bortezomib Subcutaneous or IV Other Names: 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 Names: OSI-906 Drug: Bortezomib Subcutaneous or IV Other Names: Velcade Drug: Dexamethasone IV, Oral Other Names: Maxidex Baycadron Ozurdex Decadron

Outcome Measures

Primary Outcome Measures

Number of subjects with adverse events [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site US10004	La Jolla	California	United States	92093-0987
2	Site US10006	Tampa	Florida	United States	33612
3	Site US10002	Baltimore	Maryland	United States	21287
4	Site US10008	Ann Arbor	Michigan	United States	48109
5	Site US10001	Oklahoma City	Oklahoma	United States	73104
6	Site BR55005	Porto Alegre	Rio Grande Do Sul	Brazil	90610-000
7	Site CZ42001	Ostrava-Poruba		Czechia	70852
8	Site DE49002	Berlin		Germany	10117
9	Site DE49001	Wuerzburg		Germany	97080
10	Site PL48001	Szczecin	Zachodniopomorskie	Poland	70-891
11	Site SG65002	Singapore		Singapore	308433
12	Site TH66003	Khon Kaen		Thailand	40002