Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161558
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-12-07
Brief Title:
Erlotinib in Combination With Select Tyrosine Kinase Inhibitors in Adult Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase 1 Umbrella Trial of Erlotinib In Combination With Select Tyrosine Kinase Inhibitors In Adult Patients With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09-17
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:
Cancers that return or spread after their first line of treatment are often difficult to treat with limited next step options Based on preclinical studies the EGFR-targeting tyrosine kinase inhibitor TKI Erlotinib may be better in stopping or slowing the growth of tumors when given in combination with the multitargeting TKI Lenvatinib or Axitinib Participants will be screened with a physical exam and tests including urine and blood tests imaging scans and a test of their heart function Erlotinib axitinib and lenvatinib are all capsules taken by mouth All participants will take their drugs at home every day Some participants will take erlotinib plus lenvatinib once a day Some participants will take erlotinib once a day and axitinib twice a day Assignment to one of the treatment arms will be determined by the study Participants will record their doses in a diary Treatment is given in 28-day cycles All participants will have 4 clinic visits during their first treatment cycle After that they will have a clinic visit at the start of each new cycle Imaging scans blood and urine tests and other tests will be repeated during various clinic visits Participants will remain in the study for as long as the treatment is helping them They will have follow-up phone calls after they stop treatment
Detailed Description:
Primary Objective
-To establish the safety tolerability and maximum tolerated dose MTD of the erlotinib-lenvatinib and erlotinib-axitinib combinations in adult patients with advanced solid tumors
Secondary Objective
-To evaluate the plasma pharmacokinetic profiles of erlotinib and either lenvatinib or axitinib when used in combination
Exploratory Objectives
To assess the preliminary antitumor activity of the erlotinib-lenvatinib and erlotinib-axitinib combinations in patients with advanced solid tumors
To examine changes in numbers of circulating tumor cells CTCs of epithelial cytokeratin or mesenchymal vimentin phenotype in response to the erlotinib-lenvatinib or erlotinib-axitinib combinations
To examine genomic alterations in circulating tumor DNA ctDNA that may be associated with response or resistance to the erlotinib-lenvatinib or erlotinib-axitinib combination
Study Design
This is an open-label 2-arm phase 1 trial
All agents will be administered orally in 28-day cycles Dose escalation on both arms will follow a 3 plus 3 design with intrapatient dose escalation permitted
Assignment to one of the treatment arms will be determined by the study
The study will allow accrual of patients to backfill cohorts in which patients will be enrolled on the most recently cleared dose level when accrual to the current dose level has been completed per 3 plus 3 design but the DLT monitoring period has yet to be completed at that dose level Dose-limiting toxicities will be defined during the first cycle of treatment
The accrual ceiling will be set at 70 patients
-To establish the safety tolerability and maximum tolerated dose MTD of the erlotinib-lenvatinib and erlotinib-axitinib combinations in adult patients with advanced solid tumors
Secondary Objective
-To evaluate the plasma pharmacokinetic profiles of erlotinib and either lenvatinib or axitinib when used in combination
Exploratory Objectives
To assess the preliminary antitumor activity of the erlotinib-lenvatinib and erlotinib-axitinib combinations in patients with advanced solid tumors
To examine changes in numbers of circulating tumor cells CTCs of epithelial cytokeratin or mesenchymal vimentin phenotype in response to the erlotinib-lenvatinib or erlotinib-axitinib combinations
To examine genomic alterations in circulating tumor DNA ctDNA that may be associated with response or resistance to the erlotinib-lenvatinib or erlotinib-axitinib combination
Study Design
This is an open-label 2-arm phase 1 trial
All agents will be administered orally in 28-day cycles Dose escalation on both arms will follow a 3 plus 3 design with intrapatient dose escalation permitted
Assignment to one of the treatment arms will be determined by the study
The study will allow accrual of patients to backfill cohorts in which patients will be enrolled on the most recently cleared dose level when accrual to the current dose level has been completed per 3 plus 3 design but the DLT monitoring period has yet to be completed at that dose level Dose-limiting toxicities will be defined during the first cycle of treatment
The accrual ceiling will be set at 70 patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001657-C | None | None | None |