Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385827
Status:
TERMINATED
Last Update Posted:
2014-08-20
First Post:
2006-10-06
Brief Title:
A Safety and Efficacy Study of Siltuximab CNTO 328 in Male Subjects With Metastatic Hormone-Refractory Prostate Cancer HRPC
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Phase 2 Multicenter Open-Label Study of CNTO 328 Anti-IL-6 Monoclonal Antibody in Combination With Mitoxantrone Versus Mitoxantrone in Subjects With Metastatic Hormone-Refractory Prostate Cancer HRPC
Status:
TERMINATED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Prematurely stopped after Independent Data Monitoring Committee IDMC evaluation for lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and efficacy of siltuximab administered in combination with mitoxantrone and prednisone in participants with metastatic spread of cancer cells from one part of the body to another hormone-refractory not responding to treatment prostate cancer abnormal tissue that grows and spreads in the body HRPC
Detailed Description:
This is a 2-part open-label all people know the identity of the intervention multicenter when more than 1 hospital or medical school team work on a medical research study Phase 2 study to evaluate the safety and efficacy of the combination of siltuximab plus mitoxantrone versus mitoxantrone in participants with metastatic HRPC who have received 1 prior Docetaxel-based chemotherapy treatment of disease usually cancer by chemical agents regimen pattern of giving treatment Part 1 of the study is single arm where participants will receive mitoxantrone prednisone and siltuximab Part 2 of the study is randomized portion the study drug is assigned by chance consisting of 2-arms The experimental arm will consist of treatment with mitoxantrone prednisone and siltuximab The control arm will consist of treatment with mitoxantrone and prednisone Mitoxantrone will be administered at a dose of 12 milligram per square meter mgm2 intravenously into a vein as a 30-minute infusion a fluid or a medicine delivered into a vein by way of a needle on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity any harmful effect of a drug or up to 10 cycles a maximum total dose of approximately 120 mgm2 Siltuximab will be administered at a dose of 6 mgkilogram intravenously as a 2-hour infusion starting Day 1 of Cycle 1 to continue every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year All participants will receive prednisone 5 mg twice daily starting with the first administration of Mitoxantrone The duration of treatment will be a maximum of 12 months for cumulative dose Radiologic assessments will be performed on Week 12 after the first study agent dosing then every 9 weeks until the end of treatment and then once every 3 months until documented disease progression Tumor a mass in a specific area response will be assessed using Response Evaluation Criteria in Solid Tumors RECIST criteria There will be short-term follow-up visits conducted monthly for 2 months followed by long-term follow-up visits conducted once every 3 months Participants safety will also be monitored throughout the study
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 |
|---|---|---|---|
| C0328T07 | None | None | None |
| 2006-001671-38 | EUDRACT_NUMBER | None | None |