Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033384
Status:
COMPLETED
Last Update Posted:
2013-04-12
First Post:
2002-04-09
Brief Title:
CI-1040 in Treating Patients With Advanced Breast Colon Pancreatic or Non-Small Cell Lung Cancer
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
A Multicenter Phase 2 Study of CI-1040 In Patients With Advanced Nonsmall-Cell Lung Cancer Breast Cancer Colon Cancer Or Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2002-12
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 CI-1040 may stop the growth of tumors by blocking the enzymes necessary for cancer cell growth and by stopping blood flow to the tumor
PURPOSE Phase II trial to study the effectiveness of CI-1040 in treating patients who have metastatic or unresectable breast colon pancreatic or non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of CI-1040 in treating patients who have metastatic or unresectable breast colon pancreatic or non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the antitumor activity of CI-1040 in patients with non-small cell lung breast colon or pancreatic cancer
Determine the safety profile of this drug in these patients
Assess quality of life overall and for each tumor type of patients treated with this drug
Determine the relationship between study drug concentration and antitumor response in these patients and target suppression and safety of this drug
Correlate target suppression pERK with antitumor effects of this drug in these patients
Correlate the mRNA expression profile of the tumors with antitumor effects of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to tumor type non-small cell lung vs breast vs colon vs pancreas
Patients receive oral CI-1040 twice daily on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then every 28 days during the first 6 months of study therapy
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 52-172 patients 13-43 per stratum will be accrued for this study
Determine the antitumor activity of CI-1040 in patients with non-small cell lung breast colon or pancreatic cancer
Determine the safety profile of this drug in these patients
Assess quality of life overall and for each tumor type of patients treated with this drug
Determine the relationship between study drug concentration and antitumor response in these patients and target suppression and safety of this drug
Correlate target suppression pERK with antitumor effects of this drug in these patients
Correlate the mRNA expression profile of the tumors with antitumor effects of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to tumor type non-small cell lung vs breast vs colon vs pancreas
Patients receive oral CI-1040 twice daily on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then every 28 days during the first 6 months of study therapy
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 52-172 patients 13-43 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 |
|---|---|---|---|
| UAB-0152 | None | None | None |
| PFIZER-1040-002-004 | None | None | None |
| NCI-G02-2052 | None | None | None |
| UAB-F011203011 | None | None | None |