Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-31 @ 11:30 PM
Study NCT ID:
NCT05952128
Status:
UNKNOWN
Last Update Posted:
2023-07-19
First Post:
2023-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase Ib/II Study of Fluzoparib in Combination With Dalpiciclib in Patients With Locally Advanced or Metastatic Sarcoma
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
A Single-center, Prospective, Single-arm Phase Ib/II Clinical Study on the Efficacy and Safety of Fluzoparib Combined With Dalpiciclib in the Treatment of Locally Advanced or Metastatic Sarcoma r
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
RECRUITING
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 is a single-center, single-arm phase Ib / II clinical trial, which was included with two phase. The main purpose of the phase Ib part was to determine the dose-limiting toxicity ( DLT ), maximum tolerated dose ( MTD ), and recommended dose ( RP2D ) of Fluzoparib combined with Dalpiciclib in patients with locally advanced or metastatic sarcoma. The phase II part is mainly to observe the efficacy and safety of Fluzoparib combined with Dalpiciclib.
Detailed Description:
The overall prognosis for patients with soft tissue sarcoma is not ideal, with a median survival rate of only about 20 months for patients diagnosed with metastasis. Soft tissue sarcomas (more than 50%) are deficient in HRR due to the presence of BRCA mutations in the tumor. When patients with BRCA1/2 gene mutation are treated with PARP inhibitors, a damage to DNA single strand breaks can be observed, and cannot be repaired promptly, resulting in tumor cell death. In addition, selective inhibition of CDK4/6 was found to inhibit the growth of sarcoma cells and induce their apoptosis. For example, inhibition of CDK4 decrease the proliferation of osteosarcoma cells and promote their apoptosis in vitro, and targeted CDK6 inhibition can inhibit the proliferation, invasion and migration of Ewing's sarcoma cells. Therefore, in this study, Dalpicicli, a CDK4/6 inhibitor, and Fluzoparib, a PARP inhibitor, were used in the treatment of advanced and metastatic soft tissue sarcoma, so as to explore the efficacy and safety of the combined regimen.
Study Oversight
Has Oversight DMC:
False
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?: