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

Phase 2

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: linsitinib; Drug: paclitaxel; Drug: erlotinib; Drug: Bortezomib; Drug: Dexamethasone

• Registration Number: NCT02057380
• Lead Sponsor: Astellas Pharma Global Development, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-05
• Study First Posted: 2014-02-07
• Study Start: 2014-04-16
• Primary Completion: 2016-10-14
• Study Completion: 2016-12-21
• Disposition First Submitted: 2017-10-02
• Disposition First Submitted QC: 2017-10-02
• Disposition First Posted: 2017-10-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm D: High dose linsitinib BID plus weekly paclitaxel	paclitaxel	Arm D includes subjects from Protocol OSI-906-202
Arm A: High dose linsitinib twice daily monotherapy	linsitinib	Arm A includes subjects from Protocol OSI-906-301
Arm B: High dose linsitinib BID plus high dose erlotinib QD	linsitinib	Arm B includes subjects from Protocol OSI-906-205
Arm B: High dose linsitinib BID plus high dose erlotinib QD	erlotinib	Arm B includes subjects from Protocol OSI-906-205
Arm C: High dose erlotinib monotherapy once daily	erlotinib	Arm C includes subjects from Protocol OSI-906-205 and OSI-906-207
Arm D: High dose linsitinib BID plus weekly paclitaxel	linsitinib	Arm D includes subjects from Protocol OSI-906-202
Arm E: Highest dose linsitinib intermittent once daily	paclitaxel	Arm E includes subjects from Protocol OSI-906-202, linsitinib on Days 1-3 of each week plus weekly paclitaxel
Arm F: Paclitaxel alone weekly	paclitaxel	Arm F includes subjects from Protocol OSI-906-202
Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone	Bortezomib	includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
Arm G: Lowest dose linsitinib twice daily + low dose erlotinib	erlotinib	Arm G includes subjects from Protocol OSI-906-103
Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone	linsitinib	includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
Arm I: highest dose linsitinib once daily	linsitinib	includes subjects from EuroSARC protocol, linsitinib on Days 1-3; Days 8-10 and Days 15-17
Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone	Dexamethasone	includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone	linsitinib	includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone	Bortezomib	includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone	linsitinib	includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone	Bortezomib	includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone	Dexamethasone	includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone	Dexamethasone	includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
Arm G: Lowest dose linsitinib twice daily + low dose erlotinib	linsitinib	Arm G includes subjects from Protocol OSI-906-103
Arm E: Highest dose linsitinib intermittent once daily	linsitinib	Arm E includes subjects from Protocol OSI-906-202, linsitinib on Days 1-3 of each week plus weekly paclitaxel
Arm H: high dose linsitinib twice daily	linsitinib	includes subjects from protocols SARC 022/CTEP 8945, linsitinib x28 days (each cycle)

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	24 months

Trial Locations

Locations (12)

Site US10004; 🇺🇸 La Jolla, California, United States

Site US10006; 🇺🇸 Tampa, Florida, United States

Site US10002; 🇺🇸 Baltimore, Maryland, United States

Site US10008; 🇺🇸 Ann Arbor, Michigan, United States

Site BR55005; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Site US10001; 🇺🇸 Oklahoma City, Oklahoma, United States

Site CZ42001; 🇨🇿 Ostrava-Poruba, Czechia

Site DE49001; 🇩🇪 Wuerzburg, Germany

Site DE49002; 🇩🇪 Berlin, Germany

Site PL48001; 🇵🇱 Szczecin, Zachodniopomorskie, Poland

Site SG65002; 🇸🇬 Singapore, Singapore

Site TH66003; 🇹🇭 Khon Kaen, Thailand