Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-31 @ 9:00 AM
Study NCT ID:
NCT05045404
Status:
WITHDRAWN
Last Update Posted:
2023-09-13
First Post:
2021-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Poziotinib and Ramucirumab for the Treatment of EGFR Exon 20 Mutant Stage IV Non-small Cell Lung Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Study of Poziotinib and Ramucirumab in EGFR Exon 20 Mutant Advanced Non-small Cell Lung Cancer (NSCLC)
Status:
WITHDRAWN
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed due to funding, 0 patient accrual.
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests whether poziotinib and ramucirumab work to shrink tumors in patients with EGFR Exon 20 gene mutant stage IV non-small cell lung cancer. Poziotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ramucirumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving poziotinib and ramucirumab may help to control the disease.
Detailed Description:
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of the combination of poziotinib and ramucirumab as measured by progression free survival.
SECONDARY OBJECTIVES:
I. To estimate the objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for the combination of poziotinib and ramucirumab.
II. To estimate the disease control rate (complete response + partial response + stable disease), overall survival, and duration of response of the study combination.
III. To assess the safety and the toxicity of the study combination.
EXPLORATORY OBJECTIVE:
I. To assess molecular markers associated with resistance and response to poziotinib and ramucirumab.
OUTLINE:
Patients receive poziotinib hydrochloride orally (PO) twice daily (BID) on day 1 and ramucirumab intravenously (IV) over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days, then every 6 months thereafter.
I. To evaluate the efficacy of the combination of poziotinib and ramucirumab as measured by progression free survival.
SECONDARY OBJECTIVES:
I. To estimate the objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for the combination of poziotinib and ramucirumab.
II. To estimate the disease control rate (complete response + partial response + stable disease), overall survival, and duration of response of the study combination.
III. To assess the safety and the toxicity of the study combination.
EXPLORATORY OBJECTIVE:
I. To assess molecular markers associated with resistance and response to poziotinib and ramucirumab.
OUTLINE:
Patients receive poziotinib hydrochloride orally (PO) twice daily (BID) on day 1 and ramucirumab intravenously (IV) over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days, then every 6 months thereafter.
Study Oversight
Has Oversight DMC:
True
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?: