Erlotinib in Combination With Select Tyrosine Kinase Inhibitors in Adult Patients With Advanced Solid Tumors

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06161558
Phase
PHASE1
Status
Withdrawn

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Small-molecule tyrosine kinase inhibitor targeting EGFR
  • Lenvatinib — DRUG
    Small-molecule tyrosine kinase inhibitor targeting VEGFR1, VEGFR2, and VEGFR3
  • Axitinib — DRUG
    Small-molecule tyrosine kinase inhibitor targeting VEGFR1, VEGFR2, and VEGFR3

Study Details

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....

Key Dates

First listed
Dec 8, 2023
Start date
Jul 15, 2025
Status verified
Jul 2025
Primary completion
Jul 15, 2025
Completion
Jul 15, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
    Erlotinib with lenvatinib combination
  • Experimental: B
    Erlotinib with axitinib combination

Primary Outcome Measure

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 [ Time Frame: 30 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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