Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06302621
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2022-08-10
Brief Title:
Pemigatinib Afatinib in Advanced Refractory Solid Tumors
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase IaIb Study of the Combination of the FGFR Inhibitor Pemigatinib and the EGFR Inhibitor Afatinib in Advanced Refractory Solid Tumors
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:
None
Brief Summary:
This study is researching whether the combination of Afatinib and Pemigatinib is safe and effective in FGFR altered unresectable or metastatic advanced solid tumors
The study is also trying to discover the highest doses of the study drugs that can be administered without causing any intolerable side effects
This research study involves the study drugs Afatinib and Pemigatinib
The study is also trying to discover the highest doses of the study drugs that can be administered without causing any intolerable side effects
This research study involves the study drugs Afatinib and Pemigatinib
Detailed Description:
This is an open-label phase IaIb study to evaluate safety tolerability and preliminary efficacy of the combination of pemigatinib and afatinib in patients with FGFR-altered refractory advanced solid tumors
This study includes 2 parts phase 1a dose escalation and phase 1b dose expansion
In the phase 1a dose escalation study patients with FGFR-altered refractory advanced refractory solid tumors will be enrolled
In the phase Ib dose expansion study patients with FGFR-altered cholangiocarcinoma will be recruited into 2 cohorts FGFR inhibitor-naïve cholangiocarcinoma and FGFR-inhibitor-pretreated and resistant cholangiocarcinoma
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits
This research study involves the study drugs Afatinib and Pemigatinib
Participants will receive study treatment for as long there is benefit and no unacceptable side effects Participants will be followed for up to 1 year It is expected that up to 70 people will take part in this research study
This research study is a Phase I clinical trial which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies Investigational means that the drug is being studied
The US Food and Drug Administration FDA has not approved afatinib for this specific disease but it has been approved for other uses The US Food and Drug Administration FDA has approved pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion
The FDA has not approved the combination of afatinib and pemigatinib as a treatment for any disease
This study includes 2 parts phase 1a dose escalation and phase 1b dose expansion
In the phase 1a dose escalation study patients with FGFR-altered refractory advanced refractory solid tumors will be enrolled
In the phase Ib dose expansion study patients with FGFR-altered cholangiocarcinoma will be recruited into 2 cohorts FGFR inhibitor-naïve cholangiocarcinoma and FGFR-inhibitor-pretreated and resistant cholangiocarcinoma
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits
This research study involves the study drugs Afatinib and Pemigatinib
Participants will receive study treatment for as long there is benefit and no unacceptable side effects Participants will be followed for up to 1 year It is expected that up to 70 people will take part in this research study
This research study is a Phase I clinical trial which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies Investigational means that the drug is being studied
The US Food and Drug Administration FDA has not approved afatinib for this specific disease but it has been approved for other uses The US Food and Drug Administration FDA has approved pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion
The FDA has not approved the combination of afatinib and pemigatinib as a treatment for any disease
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