Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03065387
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Malignant Solid Neoplasm
  • EGFR Gene Amplification
  • EGFR Gene Mutation
  • ERBB2 Gene Amplification
  • ERBB2 Gene Mutation
  • ERBB3 Gene Mutation
  • ERBB4 Gene Mutation
  • KRAS Gene Mutation
  • Metastatic Malignant Solid Neoplasm
  • Refractory Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Everolimus — DRUG
    Given PO
  • Neratinib — DRUG
    Given PO
  • Palbociclib — DRUG
    Given PO
  • Trametinib — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and best dose of neratinib in combination with everolimus, palbociclib, or trametinib in participants with solid tumors with EGFR mutation/amplification, HER2 mutation/amplification, HER3/4 mutation, or KRAS mutation that do not respond to treatment (refractory) and have spread to other parts of the body (advanced or metastatic). Neratinib, palbociclib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as everolimus, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving neratinib with everolimus, palbociclib, or trametinib may work better than neratinib alone in treating participants with solid tumors.

Key Dates

Start date
Oct 31, 2017
Status verified
Jan 2026
Primary completion
Oct 1, 2028
Completion
Oct 1, 2028

Study Design

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

Arms

  • Experimental: Arm I (neratinib, everolimus)
    Participants receive neratinib PO daily and everolimus PO daily. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (neratinib, palbociclib)
    Participants receive Neratinib PO daily for 28 days and Palbociclib PO daily for 21 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm III (neratinib, trametinib)
    Participants receive neratinib PO daily and trametinib PO daily as directed. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose (MTD) of neratinib when given in combination with everolimus, palbociclib, or trametinib [ Time Frame: Up to 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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