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

Astellas

Status and phase: Completed; Phase 2

Conditions: Advanced Solid Tumors

Treatments: Drug: paclitaxel; Drug: erlotinib; Drug: Dexamethasone; Drug: Bortezomib; Drug: linsitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02057380

7487-CL-0209

2013-004076-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 12 patient groups

Arm A: High dose linsitinib twice daily monotherapy

Experimental group

Description:

Arm A includes subjects from Protocol OSI-906-301

Treatment:

Drug: linsitinib

Arm B: High dose linsitinib BID plus high dose erlotinib QD

Experimental group

Description:

Arm B includes subjects from Protocol OSI-906-205

Treatment:

Drug: linsitinib

Drug: erlotinib

Arm C: High dose erlotinib monotherapy once daily

Experimental group

Description:

Arm C includes subjects from Protocol OSI-906-205 and OSI-906-207

Treatment:

Drug: erlotinib

Arm D: High dose linsitinib BID plus weekly paclitaxel

Experimental group

Description:

Arm D includes subjects from Protocol OSI-906-202

Treatment:

Drug: linsitinib

Drug: paclitaxel

Arm E: Highest dose linsitinib intermittent once daily

Experimental group

Description:

Arm E includes subjects from Protocol OSI-906-202, linsitinib on Days 1-3 of each week plus weekly paclitaxel

Treatment:

Drug: linsitinib

Drug: paclitaxel

Arm F: Paclitaxel alone weekly

Experimental group

Description:

Arm F includes subjects from Protocol OSI-906-202

Treatment:

Drug: paclitaxel

Arm G: Lowest dose linsitinib twice daily + low dose erlotinib

Experimental group

Description:

Arm G includes subjects from Protocol OSI-906-103

Treatment:

Drug: linsitinib

Drug: erlotinib

Arm H: high dose linsitinib twice daily

Experimental group

Description:

includes subjects from protocols SARC 022/CTEP 8945, linsitinib x28 days (each cycle)

Treatment:

Drug: linsitinib

Arm I: highest dose linsitinib once daily

Experimental group

Description:

includes subjects from EuroSARC protocol, linsitinib on Days 1-3; Days 8-10 and Days 15-17

Treatment:

Drug: linsitinib

Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone

Experimental group

Description:

includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)

Treatment:

Drug: linsitinib

Drug: Bortezomib

Drug: Dexamethasone

Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone

Experimental group

Description:

includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)

Treatment:

Drug: linsitinib

Drug: Bortezomib

Drug: Dexamethasone

Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone

Experimental group

Description:

includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)

Treatment:

Drug: linsitinib

Drug: Bortezomib

Drug: Dexamethasone