Ignite Creation Date:
2024-05-06 @ 10:37 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03307148
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2017-08-30
Brief Title:
Stromal TARgeting for PAncreatic Cancer STAR_PAC
Sponsor:
Barts The London NHS Trust
Organization:
Barts The London NHS Trust
Study Overview
Official Title:
A Phase 1B Study Repurposing ATRA as Stromal Targeting Agent Along With Gemcitabine and Nab-Paclitaxel for Pancreatic Cancer STAR_PAC
Status:
COMPLETED
Status Verified Date:
2020-01
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:
STAR_PAC
Brief Summary:
Pancreatic cancer PDAC is the fourth highest cancer killer worldwide and is responsible for 6 of cancer deaths Around 80 of patients are diagnosed at a late stage when cancer has spread and surgical removal is no longer possible At present there are no treatments available which will shrink the tumour to enable surgical removal
A main factor in the lack of treatment options for patients is that pancreatic cancer is surrounded by a thick scar tissue called the stroma which forms a barrier to prevent chemotherapy from entering and shrinking the tumour Research carried out in laboratories has shown that a derivative of Vitamin A All Trans Retinoic Acid ATRA may have the ability to break down this stroma allowing chemotherapy to reach the cancer
STAR_PAC will test the combination of ATRA with two chemotherapy drugs Gemcitabine and Nab-Paclitaxel in patients with locally advanced or metastatic pancreatic cancer There are two parts to the study the first will test different doses of the drugs on around 24 patients to find the highest dose patients can take without too many side effects The second part will test this dose on around 10 patients to find the dose that will produce the desired effect with limited side effects Patients will take ATRA for up to 6 cycles and chemotherapy until their cancer worsens and will be followed up for 12 months The study will also explore the ability of a type of scan DW-MRI to detect changes in the cancer optional for patients Patients can also opt to donate additional tumour samples biopsies and normal cell samples cheek cells and hair samples
Eligible patients will be recruited through NHS Clinics and should have histologically confirmed locally advanced or metastatic pancreatic cancer according to RECIST criteria and must have received no prior treatment for this cancer
A main factor in the lack of treatment options for patients is that pancreatic cancer is surrounded by a thick scar tissue called the stroma which forms a barrier to prevent chemotherapy from entering and shrinking the tumour Research carried out in laboratories has shown that a derivative of Vitamin A All Trans Retinoic Acid ATRA may have the ability to break down this stroma allowing chemotherapy to reach the cancer
STAR_PAC will test the combination of ATRA with two chemotherapy drugs Gemcitabine and Nab-Paclitaxel in patients with locally advanced or metastatic pancreatic cancer There are two parts to the study the first will test different doses of the drugs on around 24 patients to find the highest dose patients can take without too many side effects The second part will test this dose on around 10 patients to find the dose that will produce the desired effect with limited side effects Patients will take ATRA for up to 6 cycles and chemotherapy until their cancer worsens and will be followed up for 12 months The study will also explore the ability of a type of scan DW-MRI to detect changes in the cancer optional for patients Patients can also opt to donate additional tumour samples biopsies and normal cell samples cheek cells and hair samples
Eligible patients will be recruited through NHS Clinics and should have histologically confirmed locally advanced or metastatic pancreatic cancer according to RECIST criteria and must have received no prior treatment for this cancer
Detailed Description:
None
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 |
|---|---|---|---|
| 2015-002662-23 | EUDRACT_NUMBER | None | None |