Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896073
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2021-05-20
Brief Title:
Superenhancer Inhibitor Minnelide in Advanced Refractory Adenosquamous Carcinoma of the Pancreas ASCP
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Trial of the Superenhancer Inhibitor Minnelide in Advanced Refractory Adenosquamous Carcinoma of the Pancreas ASCP
Status:
RECRUITING
Status Verified Date:
2024-09-26
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:
Background
Pancreatic cancer is one of the most lethal types of cancer ASCP is a highly aggressive type of pancreatic cancer It is very rare Researchers want to see if a drug called Minnelide can be used to treat ASCP
Objective
To see if Minnelide is an effective treatment for ASCP
Eligibility
Adults ages 18 and older with ASCP whose cancer did not respond to previous treatments
Design
Participants will be screened with
Medical history
Physical exam
Blood and urine samples
Evaluation of ability to do daily activities
Electrocardiogram to test heart function
Body andor brain scans For these participants will lie in a machine that takes pictures of the body They may have a contrast agent injected into a vein
Tumor sample If one is not available participants will have a tumor biopsy The biopsy will be taken with a small needle put through the skin into the tumor
Treatment will be given in 28-day cycles for up to 12 cycles There is a 7-day resting period between cycles Participants will take Minnelide by mouth every day for 21 days of each cycle They will keep a medicine diary
Participants will have at least 1 study visit every cycle They will review their medicine diary They will repeat some screening tests
Participants may have optional tumor biopsies Some participants may need to take birth control during the study and for up to 6 months after treatment
Participants will have an end-of-treatment visit 4 weeks after they stop taking the study drug They will repeat some screening tests
Pancreatic cancer is one of the most lethal types of cancer ASCP is a highly aggressive type of pancreatic cancer It is very rare Researchers want to see if a drug called Minnelide can be used to treat ASCP
Objective
To see if Minnelide is an effective treatment for ASCP
Eligibility
Adults ages 18 and older with ASCP whose cancer did not respond to previous treatments
Design
Participants will be screened with
Medical history
Physical exam
Blood and urine samples
Evaluation of ability to do daily activities
Electrocardiogram to test heart function
Body andor brain scans For these participants will lie in a machine that takes pictures of the body They may have a contrast agent injected into a vein
Tumor sample If one is not available participants will have a tumor biopsy The biopsy will be taken with a small needle put through the skin into the tumor
Treatment will be given in 28-day cycles for up to 12 cycles There is a 7-day resting period between cycles Participants will take Minnelide by mouth every day for 21 days of each cycle They will keep a medicine diary
Participants will have at least 1 study visit every cycle They will review their medicine diary They will repeat some screening tests
Participants may have optional tumor biopsies Some participants may need to take birth control during the study and for up to 6 months after treatment
Participants will have an end-of-treatment visit 4 weeks after they stop taking the study drug They will repeat some screening tests
Detailed Description:
Background
Adenosquamous carcinoma of the pancreas ASCP is a highly aggressive variant of pancreatic ductal adenocarcinoma PDA the most common type of pancreas cancer
ASCP is estimated to account for 05-4 of the 55000 people who are diagnosed with pancreatic cancer in the US each year making it a very rare tumor type
No prospective clinical trials specific to ASCP have ever been performed
Preclinical data in ASCP models indicate that an activated superenhancer network drives epigenetic changes which cause the prognostically unfavorable squamous differentiation
Genomic analysis of ASCP tumors identifies frequent amplification of MYC
Minnelide is a small molecule anti-superenhancer drug that inhibits MYC
The recommended dose of Minnelide has previously been established through clinical testing for other indications
Primary Objective
-To determine the single agent antitumor activity disease control rate of the anti-superenhancer agent Minnelide in participants with advanced previously treated ASCP
Eligibility
Age 18 years
Histologically confirmed ASCP or high suspicion for ASCP based on histologic analysis
for squamous markers
Participants with metastatic or locally advanced unresectable disease and progression on at least 1 prior treatment regimen
Design
This is a phase II single cohort clinical trial with one arm
The number of evaluable participants needed for the primary endpoint is 25 maximum accrual set at 55 participants accounting for screen failures and inevaluable participants
iNITIALparticipants will receive Minnelide at 2 mgday PO on Days 1-21 of a 28 day cycle
Later participants will receive a higher dose of 25 mgday PO on the same schedule
Treatment will be continued for up to 12 cycles 1 year in the absence of disease progression or unacceptable toxicity
Treatment response will be assessed by imaging every 2 cycles 8 weeks
Optional tumor biopsies will be requested mid-cycle 1 and at time of progression
A disease control rate of 40 in this highly refractory population would constitute a positive study Up to 12 participants will treated be initially If 3 of the 12 participants have a response then up to 13 additional participants will be entered to determine the true response rate
Adenosquamous carcinoma of the pancreas ASCP is a highly aggressive variant of pancreatic ductal adenocarcinoma PDA the most common type of pancreas cancer
ASCP is estimated to account for 05-4 of the 55000 people who are diagnosed with pancreatic cancer in the US each year making it a very rare tumor type
No prospective clinical trials specific to ASCP have ever been performed
Preclinical data in ASCP models indicate that an activated superenhancer network drives epigenetic changes which cause the prognostically unfavorable squamous differentiation
Genomic analysis of ASCP tumors identifies frequent amplification of MYC
Minnelide is a small molecule anti-superenhancer drug that inhibits MYC
The recommended dose of Minnelide has previously been established through clinical testing for other indications
Primary Objective
-To determine the single agent antitumor activity disease control rate of the anti-superenhancer agent Minnelide in participants with advanced previously treated ASCP
Eligibility
Age 18 years
Histologically confirmed ASCP or high suspicion for ASCP based on histologic analysis
for squamous markers
Participants with metastatic or locally advanced unresectable disease and progression on at least 1 prior treatment regimen
Design
This is a phase II single cohort clinical trial with one arm
The number of evaluable participants needed for the primary endpoint is 25 maximum accrual set at 55 participants accounting for screen failures and inevaluable participants
iNITIALparticipants will receive Minnelide at 2 mgday PO on Days 1-21 of a 28 day cycle
Later participants will receive a higher dose of 25 mgday PO on the same schedule
Treatment will be continued for up to 12 cycles 1 year in the absence of disease progression or unacceptable toxicity
Treatment response will be assessed by imaging every 2 cycles 8 weeks
Optional tumor biopsies will be requested mid-cycle 1 and at time of progression
A disease control rate of 40 in this highly refractory population would constitute a positive study Up to 12 participants will treated be initially If 3 of the 12 participants have a response then up to 13 additional participants will be entered to determine the true response rate
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 |
|---|---|---|---|
| 000254-C | None | None | None |