Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102609
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2005-01-31
Brief Title:
A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Phase I Study to Determine the Dose of the Combination of Yondelis and Doxorubicin for Which Neutropenia is Manageable With the Support of Granulocyte-Colony Stimulation Factor in Subjects With Recurrent or Persistent Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2013-01
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:
The purpose of the study is to determine the dose of the combination of trabectedin Yondelis and Doxorubicin for which neutropenia low white blood cell counts could be managed with filgrastim a Granulocyte-Colony Stimulation Factor that is used to help control neutropenia in patients with a type of cancer called soft tissue sarcoma
Detailed Description:
This is a multicenter open-label identity of the assigned study treatments will be known to patients and study staff study to determine the dose of the combination of trabectedin Yondelis and Doxorubicin for which the neutropenia low white blood cell counts is manageable with the use of filgrastim an agent used to manage neutropenia and associated with clinically acceptable number of side effects severe enough to continuation of treatment in patients with recurrent or persistent soft tissue sarcoma STS a malignant tumor that attacks the bodys infrastructure of fat muscles nerves joints blood vessels or deep skin tissues Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained Patients will be required to attend regular clinic visits to receive study medication and have their status monitored A detailed explanation can be provided by the study physician Investigator conducting this study Doxorubicin 50 to 75 mgm2 will be given as a 10-15 minute intravenous iv infusion on Day 1 via a central venous catheter which is a tube placed into a large vein Trabectedin 09 to 13 mgm2 will be given as a 3 hour iv infusion immediately following the administration of doxorubicin Dexamethasone 20 mg will be given within 1 hour before the start of each doxorubicin iv infusion and filgrastim will be administered according to manufacturers instructions
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 |
|---|---|---|---|
| ET743SAR1001 | OTHER | Johnson Johnson Pharmaceutical Research and Development LLC | None |