Ignite Creation Date:
2024-05-06 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05064618
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2021-08-18
Brief Title:
Investigator-initiated Clinical Trial of MIKE-1
Sponsor:
Nagoya University
Organization:
Nagoya University
Study Overview
Official Title:
Phase III Investigator-initiated Clinical Trial of MIKE-1 With Gemcitabine and Nab-paclitaxel Combination Therapy for Unresectable Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
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:
MIKE-1
Brief Summary:
To evaluate the safety and tolerability of Am80Generic name Tamibarotene Development code MIKE-1 in combination with gemcitabine GEM and nab-paclitaxel nab-PTX in patients with unresectable pancreatic cancer and to determine the recommended dose Efficacy will also be exploratively investigated
Detailed Description:
Cancer-associated fibroblasts CAFs are an important component of the tumor microenvironment The most common notion in the CAF research field has been that CAFs promote cancer progression through various mechanisms Interestingly however recent studies have revealed that CAFs are heterogeneous and that CAF subsets that suppress cancer progression cancer-restraining CAFs rCAFs must exist in addition to well-characterized cancer-promoting CAFs pCAFs However the identity and specific markers of rCAFs have not been reported
The investigators recently identified Meflin as a specific marker protein of rCAFs in pancreatic and colon cancers The investigators studies revealed that rCAFs are similar to a small subset of resident fibroblasts which is consistent with the famous hypothesis proposed by Micheal Stoker University of Glasgow more than 50 years ago stating that static normal fibroblasts suppress tumor growth Interestingly The investigators lineage tracing experiments showed that Meflin-positive rCAFs differentiate into Meflin-negative pCAFs during cancer progression These studies revealed that the tumor stroma is comprised of pCAFs and rCAFs which is analogous to the heterogeneity of tumor-infiltrating immune cells eg protumor regulatory T cells versus antitumor cytotoxic T cells
The identification of the rCAF marker Meflin enabled the investigators to develop new strategies to convert or reprogram pCAFs to rCAFs Using a pharmacological approach The investigators performed a chemical library screen and identified Am80 a synthetic unnatural retinoid as a reagent that effectively converts Meflin-negative pCAFs to Meflin-positive rCAFs Am80 administration improved the sensitivity of pancreatic cancer to chemotherapeutics These data suggested that the conversion of pCAF to rCAFs may represent a new strategy for pancreatic cancer treatment
The object of this study is to perform an investigator-initiated clinical study to investigate the effect of AM80 on pancreatic cancer with a combination of conventional tumoricidal agents including gemcitabine and nab-paclitaxel
The investigators recently identified Meflin as a specific marker protein of rCAFs in pancreatic and colon cancers The investigators studies revealed that rCAFs are similar to a small subset of resident fibroblasts which is consistent with the famous hypothesis proposed by Micheal Stoker University of Glasgow more than 50 years ago stating that static normal fibroblasts suppress tumor growth Interestingly The investigators lineage tracing experiments showed that Meflin-positive rCAFs differentiate into Meflin-negative pCAFs during cancer progression These studies revealed that the tumor stroma is comprised of pCAFs and rCAFs which is analogous to the heterogeneity of tumor-infiltrating immune cells eg protumor regulatory T cells versus antitumor cytotoxic T cells
The identification of the rCAF marker Meflin enabled the investigators to develop new strategies to convert or reprogram pCAFs to rCAFs Using a pharmacological approach The investigators performed a chemical library screen and identified Am80 a synthetic unnatural retinoid as a reagent that effectively converts Meflin-negative pCAFs to Meflin-positive rCAFs Am80 administration improved the sensitivity of pancreatic cancer to chemotherapeutics These data suggested that the conversion of pCAF to rCAFs may represent a new strategy for pancreatic cancer treatment
The object of this study is to perform an investigator-initiated clinical study to investigate the effect of AM80 on pancreatic cancer with a combination of conventional tumoricidal agents including gemcitabine and nab-paclitaxel
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| jRCT2041210056 | REGISTRY | jRCT | None |