Larotrectinib for the Treatment of NTRK Amplification Positive, Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04879121
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm

Eligibility Criteria

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

Interventions

  • Larotrectinib Sulfate — DRUG
    Given PO

Study Details

This phase II trial studies the effect of larotrectinib in treating patients with NTRK gene amplification positive solid tumors that have spread to nearby tissues or lymph nodes (locally advanced) or other places in the body (metastatic). Larotrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Apr 30, 2021
Status verified
Apr 2026
Primary completion
Nov 11, 2027
Completion
Nov 11, 2027

Study Design

Enrollment
13 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (larotrectinib sulfate)
    Patients receive larotrectinib sulfate PO BID on days 1-28. Cycles repeat every 28 days in the absence of unacceptable toxicity. Patients who experience disease progression and are deriving clinical benefit from larotrectinib may continue treatment per physician discretion.

Primary Outcome Measure

Overall response [ Time Frame: Up to 2 years post-treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
David S. Hong
713-563-1930
David S. Hong (PRINCIPAL_INVESTIGATOR)

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M D Anderson Cancer Center· Houston, TX

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