Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT06161558
Status:
WITHDRAWN
Last Update Posted:
2025-07-16
First Post:
2023-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Erlotinib in Combination With Select Tyrosine Kinase Inhibitors in Adult Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute (NCI)
Organization:
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:
WITHDRAWN
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of resources to complete study objectives. No participants enrolled.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 001657-C | None | None | View |