Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454383
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-06
Brief Title:
Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Phase 1b Study of Gemcitabine and Leflunomide in Patients With Unresectable Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This phase Ib trial tests the safety side effects and best dose of leflunomide in combination with gemcitabine in treating patients with pancreatic cancer that may have spread from where it first started to nearby tissue lymph nodes or distant parts of the body advanced and cannot be removed by surgery unresectable Improving the effectiveness of gemcitabine without increasing side effects could lead to a greater impact for pancreatic cancer patients survival and quality of life Gemcitabine is commonly used as a first-line chemotherapy treatment for pancreatic cancer Leflunomide is a drug approved for use against rheumatoid arthritis that is being looked at as a cancer treatment option It has shown promising results when combined with gemcitabine Giving gemcitabine in combination with leflunomide may be safe and effective in treating patients with advanced unresectable pancreatic cancer
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the safety and tolerability of gemcitabine in combination with leflunomide and determine the recommended Phase 2 dose RP2D of the combination
SECONDARY OBJECTIVES
I To evaluate the progression-free PFS and overall survival OS II To evaluate the overall response rate ORR including confirmed and unconfirmed complete and partial response and stable disease
III To describe quality of life utilizing the Functional Assessment of Cancer Therapy General FACT-G questionnaire
EXPLORATORY OBJECTIVES
I To describe the pharmacokinetic profile of leflunomide when given in combination with gemcitabine
II To examine the relationship between pharmacokinetics and disease progression
OUTLINE
Patients receive gemcitabine intravenously IV over 30 minutes on days 1 8 and 15 of each cycle and leflunomide orally PO once daily QD on days -3 to -1 prior to cycle 1 and days 1-28 of each cycle thereafter Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also receive cholestyramine PO three times a day TID for 11 days at the end of treatment in the absence of unacceptable toxicity Patients also undergo computed tomography CT magnetic resonance imaging MRI or other imaging scans as clinically indicated throughout the study as well as blood sample collection on study and during follow up
After completion of study treatment patients are followed up at 30 days then up to 1 year
I To evaluate the safety and tolerability of gemcitabine in combination with leflunomide and determine the recommended Phase 2 dose RP2D of the combination
SECONDARY OBJECTIVES
I To evaluate the progression-free PFS and overall survival OS II To evaluate the overall response rate ORR including confirmed and unconfirmed complete and partial response and stable disease
III To describe quality of life utilizing the Functional Assessment of Cancer Therapy General FACT-G questionnaire
EXPLORATORY OBJECTIVES
I To describe the pharmacokinetic profile of leflunomide when given in combination with gemcitabine
II To examine the relationship between pharmacokinetics and disease progression
OUTLINE
Patients receive gemcitabine intravenously IV over 30 minutes on days 1 8 and 15 of each cycle and leflunomide orally PO once daily QD on days -3 to -1 prior to cycle 1 and days 1-28 of each cycle thereafter Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also receive cholestyramine PO three times a day TID for 11 days at the end of treatment in the absence of unacceptable toxicity Patients also undergo computed tomography CT magnetic resonance imaging MRI or other imaging scans as clinically indicated throughout the study as well as blood sample collection on study and during follow up
After completion of study treatment patients are followed up at 30 days then up to 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| P30CA033572 | NIH | City of Hope Medical Center | httpsreporternihgovquickSearchP30CA033572 |
| NCI-2024-04359 | REGISTRY | None | None |
| 23540 | OTHER | None | None |