Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003989
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
1999-11-01
Brief Title:
ISIS 3521 in Treating Patients With Advanced Unresectable or Metastatic Non-small Cell Lung Cancer or Unresectable or Metastatic Melanoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Trial With ISIS 3521CGP 64128A in Patients With Malignant Melanoma and Non Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of ISIS 3521 in treating patients who have advanced unresectable or metastatic non-small cell lung cancer or unresectable or metastatic melanoma
PURPOSE Phase II trial to study the effectiveness of ISIS 3521 in treating patients who have advanced unresectable or metastatic non-small cell lung cancer or unresectable or metastatic melanoma
Detailed Description:
OBJECTIVES I Determine the complete and partial response rates and duration of response in patients with locally advanced unresectable or metastatic non-small cell lung cancer or unresectable or metastatic melanoma treated with ISIS 3521 II Determine safety of ISIS 3521 in these patients
OUTLINE This is a multicenter study Patients are stratified by disease type Patients receive ISIS 3521 IV over 21 days followed by 7 days of rest Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 28-50 patients 14-25 per stratum will be accrued for this study
OUTLINE This is a multicenter study Patients are stratified by disease type Patients receive ISIS 3521 IV over 21 days followed by 7 days of rest Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 28-50 patients 14-25 per stratum will be accrued for this 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 |
|---|---|---|---|
| ISIS-EORTC-16977 | None | None | None |
| EORTC-16977 | None | None | None |