Ignite Creation Date:
2024-05-06 @ 2:27 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02048488
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2014-01-20
Brief Title:
A Phase IIIa Open-Label Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas
Sponsor:
Tesaro Inc
Organization:
Tesaro Inc
Study Overview
Official Title:
A Phase IIIa Open-Label Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
TSR-011 is a potent small molecule inhibitor of tyrosine kinases involved in cancer including
1 Anaplastic lymphoma kinase ALK
2 The tropomyosin-related kinases TRKA TRKB and TRKC
This is a sequential open-label non-randomized study with dose escalation in Phase 1 followed by expansion at a recommended phase 2 dose
1 Anaplastic lymphoma kinase ALK
2 The tropomyosin-related kinases TRKA TRKB and TRKC
This is a sequential open-label non-randomized study with dose escalation in Phase 1 followed by expansion at a recommended phase 2 dose
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None