Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00046423
Status:
COMPLETED
Last Update Posted:
2016-11-25
First Post:
2002-09-30
Brief Title:
A Trial of ABI-007 in Patients With Advanced Non-Hematologic Malignancies
Sponsor:
Celgene Corporation
Organization:
Celgene Corporation
Study Overview
Official Title:
A Phase I Trial of ABI-007 Administered Weekly for Three Doses Every 4 Weeks in Patients With Advanced Non-hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial will treat patients with advanced metastatic cancer with a new chemotherapeutic agent that may be more readily tolerated than some standard therapies Patients will be given the new chemotherapeutic medicine once a week by intravenous route for three weeks followed by a rest week Treatment will be repeated in four week cycles if the patient improves on the therapy and if there are no adverse events that require withdrawal of medication
Detailed Description:
This will be a dose-escalating study ABI-007 will be administered as an outpatient infusion for three weeks followed by a week of rest The treatment course will repeat every 28 days No pretreatment will normally be considered necessary Patients will have white blood cell and platelet counts monitored as will indications of performance Karnofsky Performance Status and will be asked to describe adverse events if present Patients will be treated for a minimum of two cycles to be evaluable for the study and may continue in the study for four cycles within the study if tumor response and safety parameters warrant continuing Patients may continue on study medication beyond this at the investigators discretion
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