Ignite Creation Date:
2024-05-06 @ 12:35 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01605526
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2012-05-04
Brief Title:
A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Multi-center Open-label Phase IB Study of Escalating Doses of RO5045337 an Oral Small Molecule MDM2 Antagonist in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2016-11
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:
This multicenter open-label Phase 1b study will evaluate the safety pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 1-3 of each 28-day cycle in combination with doxorubicin 60 mgm2 intravenously on Day 1 of each cycle for up to 6 cycles
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-006279-21 | EUDRACT_NUMBER | None | None |