Clinical trial · Interventional
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
NCT02057380CI-TRIAL-00082778completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| erlotinib | Drug | Erlotinib | ALIAS |
| linsitinib | Drug | Linsitinib | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (12)
- type
- EXPERIMENTAL
- label
- Arm A: High dose linsitinib twice daily monotherapy
- description
- Arm A includes subjects from Protocol OSI-906-301
- interventionNames
- Drug: linsitinib
- type
- EXPERIMENTAL
- label
- Arm B: High dose linsitinib BID plus high dose erlotinib QD
- description
- Arm B includes subjects from Protocol OSI-906-205
- interventionNames
- Drug: linsitinib
- Drug: erlotinib
- type
- EXPERIMENTAL
- label
- Arm C: High dose erlotinib monotherapy once daily
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.