Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-02 @ 5:18 AM
Study NCT ID:
NCT00610792
Status:
WITHDRAWN
Last Update Posted:
2009-07-14
First Post:
2008-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study of Twice Weekly VELCADE and CAELYX in Patients With Ovarian Cancer Failing Platinum Containing Regimens
Sponsor:
Millennium Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
An Open Label, Phase 2 Study of Biweekly VELCADE and Intermittent CAELYX in Patients With Ovarian Cancer Failing Platinum Containing Regimens
Status:
WITHDRAWN
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study never submitted to IND. Study is being sponsored by Johnson and Johnson in the EU only.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This a Phase 2, multicenter open label, uncontrolled 2-step design. Patients will be arranged in two groups based upon the response to their last platinum containing therapy. The two groups are, 1) Platinum Resistant Patients: patients with progressive disease while on platinum containing therapy or stable disease after at least 4 cycles; patients relapsing following an objective response while still receiving treatment; patients relapsing after an objective response within 6 months from the discontinuation of the last chemotherapy and 2) Platinum-Sensitive Patients: patients who relapsed following an objective response after 6 months from the discontinuation of platinum containing chemotherapy. All patients will receive pyridoxine at least 200mg by mouth daily beginning approximately one week prior to the initiation of the combination chemotherapy and it will continue up to the end of the last treatment cycle.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| S043VELC02 | None | None | View |