A Phase 2 interventional study of linsitinib and erlotinib in Advanced Solid Tumors, sponsored by Astellas Pharma Global Development, Inc.. Completed at 12 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Astellas Pharma Global Development, Inc. · Phase 2, Interventional, and Treatment
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.
Astellas Pharma Global Development, Inc. is the lead sponsor of 204 studies on the registry; 25 are open to participants now.
Of its 80 completed or terminated interventional studies of FDA-regulated products, 38 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Arm A includes subjects from Protocol OSI-906-301
Drug: linsitinib
Arm B includes subjects from Protocol OSI-906-205
Drug: linsitinib · Drug: erlotinib
Arm C includes subjects from Protocol OSI-906-205 and OSI-906-207
Drug: erlotinib
Arm D includes subjects from Protocol OSI-906-202
Drug: linsitinib · Drug: paclitaxel
Arm E includes subjects from Protocol OSI-906-202, linsitinib on Days 1-3 of each week plus weekly paclitaxel
Drug: linsitinib · Drug: paclitaxel
Arm F includes subjects from Protocol OSI-906-202
Drug: paclitaxel
Arm G includes subjects from Protocol OSI-906-103
Drug: linsitinib · Drug: erlotinib
includes subjects from protocols SARC 022/CTEP 8945, linsitinib x28 days (each cycle)
Drug: linsitinib
includes subjects from EuroSARC protocol, linsitinib on Days 1-3; Days 8-10 and Days 15-17
Drug: linsitinib
includes subjects from protocol MM-001; Days 1, 4, 8 \& 11 (cycles 1-8) and Days 1, 8, 15 \& 22 (cycles 9+)
Drug: linsitinib · Drug: Bortezomib · Drug: 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 · Drug: Bortezomib · Drug: 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 · Drug: Bortezomib · Drug: Dexamethasone
oral
Also known as: OSI-906
oral
Also known as: OSI-774, Tarceva
Intravenous (IV) infusion
Subcutaneous or IV
Also known as: Velcade
IV, Oral
Also known as: Maxidex, Baycadron, Ozurdex, Decadron
Number of subjects with adverse events
Time frame: 24 months
Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Global Development, Inc.