Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05830084
Status:
RECRUITING
Last Update Posted:
2023-05-11
First Post:
2023-04-13
Brief Title:
Phase Ib Regorafenib With Conventional ChemotherapyNewly Diagnosed Patients Multimetastatic Ewing Sarcoma
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
Phase Ib Study of the Combination of Regorafenib With Conventional Chemotherapy for the Treatment of Newly Diagnosed Patients With Multimetastatic Ewing Sarcoma
Status:
RECRUITING
Status Verified Date:
2023-05
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:
REGO-EWING
Brief Summary:
New drug efficacy in ES has been disappointing in the last decades and no new drugs have been successfully introduced up to now in front line treatment Among the tested drugs early clinical data suggest that strategies using multi-targeted tyrosine kinase inhibitors TKI with anti-angiogenic activities are among the most efficient and may be beneficial in the treatment of patients with ES
Several TKI have been and are currently being tested as single-agent in patients with relapsedrefractory ES with encouraging results in phase II trials Regorafenib has shown promising activity in Ewing sarcoma relapse setting Nevertheless regorafenib has never been combined with the intensive chemotherapy VDCIE schedule and therefore this combination needs to be evaluated in order to avoid dose reduction of the current standard treatment and hence its efficacy
The current clinical trial has been therefore designed to test the feasibility of regorafenib with ES conventional chemotherapy It consists of a phase Ib that will only recruit patients with multi-metastatic other than lungspleura only ES that present the highest unmet medical need 2 year EFS 33 similar to patients with relapserefractory ES
Several TKI have been and are currently being tested as single-agent in patients with relapsedrefractory ES with encouraging results in phase II trials Regorafenib has shown promising activity in Ewing sarcoma relapse setting Nevertheless regorafenib has never been combined with the intensive chemotherapy VDCIE schedule and therefore this combination needs to be evaluated in order to avoid dose reduction of the current standard treatment and hence its efficacy
The current clinical trial has been therefore designed to test the feasibility of regorafenib with ES conventional chemotherapy It consists of a phase Ib that will only recruit patients with multi-metastatic other than lungspleura only ES that present the highest unmet medical need 2 year EFS 33 similar to patients with relapserefractory ES
Detailed Description:
All included patients will receive standard Ewing sarcoma ES treatment concomitant with regorafenib
Standard ES treatment consists of induction chemotherapy VDCIE and local treatment surgeryradiotherapy followed by consolidation chemotherapy VCIE Bu-Mel according to physician and patient choice
Regorafenib will be administered during induction chemotherapy VDCIE and during consolidation chemotherapy with conventional chemotherapy VCIE but not Bu-Mel therapy
Conventional chemotherapy will be administered at the recommended dose 100 and only regorafenib will be escalatedde-escalated starting at DL0
DL1 82 mgm2 once daily for 21 days28 days max 160mg 100 of the RP2D
DL0 starting dose 66 mgm2 once daily for 21 days28 days max 120mg 80 of the RP2D
DL-1 50 mgm2 once daily for 21 days28 days max 80mg 60 of the RP2D Regorafenib will be stopped 2 weeks before planned surgery of the primary tumor and reintroduced when adequate wound healing is obtained concomitant with consolidation VCIE chemotherapy
Regorafenib will only be given concomitant to radiotherapy in case the primary tumor is located in the extremities In case of primary tumors located in the pelvis abdomen thorax spine brain head or neck regorafenib will be stopped at least 1 week before start of radiotherapy
Standard ES treatment consists of induction chemotherapy VDCIE and local treatment surgeryradiotherapy followed by consolidation chemotherapy VCIE Bu-Mel according to physician and patient choice
Regorafenib will be administered during induction chemotherapy VDCIE and during consolidation chemotherapy with conventional chemotherapy VCIE but not Bu-Mel therapy
Conventional chemotherapy will be administered at the recommended dose 100 and only regorafenib will be escalatedde-escalated starting at DL0
DL1 82 mgm2 once daily for 21 days28 days max 160mg 100 of the RP2D
DL0 starting dose 66 mgm2 once daily for 21 days28 days max 120mg 80 of the RP2D
DL-1 50 mgm2 once daily for 21 days28 days max 80mg 60 of the RP2D Regorafenib will be stopped 2 weeks before planned surgery of the primary tumor and reintroduced when adequate wound healing is obtained concomitant with consolidation VCIE chemotherapy
Regorafenib will only be given concomitant to radiotherapy in case the primary tumor is located in the extremities In case of primary tumors located in the pelvis abdomen thorax spine brain head or neck regorafenib will be stopped at least 1 week before start of radiotherapy
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 |
|---|---|---|---|
| 20223545 | OTHER | CSET number | None |