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New treatment option for Locally Advanced Malignant Solid Neoplasm
Official title Larotrectinib for the Treatment of NTRK Amplification Positive, Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT04879121
What this study is testing
What is Larotrectinib Sulfate?
Larotrectinib Sulfate is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for locally advanced malignant solid neoplasm.
Also referred to as ARRY 470 Sulfate, LOXO 101 Sulfate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- At least 16 years of age
- Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene amplification identified through molecular assays (such as IHC and any...
- Must have received prior standard therapy appropriate for tumor type and stage of disease, or, in the opinion of the investigator, is unlikely to...
- Must have at least one measurable lesion as defined by RECIST v1.1. people with primary CNS tumors should meet the following criteria:
- Must have received prior treatment including radiation and/or chemotherapy, with radiation completed \> 12 weeks prior to cycle 1 day 1 (C1D1) of...
You likely can't join if
- Investigational agent or anticancer therapy within 2 weeks prior to the planned start of larotrectinib or five half-lives, whichever is shorter, and...
- Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK. However, people who received less than 28...
- Symptomatic or unstable brain metastases that needs corticosteroid usage. people with asymptomatic brain metastases or primary CNS tumors are eligible
- Uncontrolled concurrent malignancy that would limit assessment of how well it works. Allowed diseases may include, but are not limited to in situ...
- Active uncontrolled systemic bacterial, viral, or fungal infection, unstable cardiovascular disease or other systemic disease that would limit...
- Persistently uncontrolled hypertension defined as systolic blood pressure (BP) \> 150 mmHg and/or diastolic BP \> 100 mmHg despite antihypertensive...
See the full eligibility criteria
- At least 16 years of age
- Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene amplification identified through molecular assays (such as IHC and any next-generation sequencing [NGS] platform, reference lab NGS, or in...
- Must have received prior standard therapy appropriate for tumor type and stage of disease, or, in the opinion of the investigator, is unlikely to tolerate or derive clinically meaningful benefit from appropriate...
- Must have at least one measurable lesion as defined by RECIST v1.1. people with primary CNS tumors should meet the following criteria:
- Must have received prior treatment including radiation and/or chemotherapy, with radiation completed \> 12 weeks prior to cycle 1 day 1 (C1D1) of therapy, as recommended or appropriate for the tumor type
- Must have \>= 1 site of bi-dimensionally measurable disease (confirmed by magnetic resonance imaging [MRI] and evaluable by RANO), with the size of at least one of the measurable lesions \>= 1 cm in each dimension
- Must have imaging study within 28 days before enrollment. If on steroid therapy, the dose must be stable for at least five days immediately before and during the imaging study
- Eastern Cooperative Oncology Group (ECOG) score =\ = 70 %
- Archived tumor tissue. If archival tissue is unavailable, an on-study tumor biopsy should be attempted if it can be safely performed
- Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) \< 2.5 x upper limit of normal (ULN) or \< 5 x ULN if liver function abnormalities are due to underlying malignancy
- Total bilirubin \< 2.5 x ULN, except in cases of biliary obstruction. people with a known history of Gilberts disease and an isolated elevation of indirect bilirubin are eligible
- Serum creatinine \ = 30 mL/minute using the Cockcroft-Gault formula
- Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation
- Willingness of men and women of reproductive potential to use two effective birth control methods, one used by the subject and another by his/her partner, for the duration of treatment and for 3 months following study...
- Investigational agent or anticancer therapy within 2 weeks prior to the planned start of larotrectinib or five half-lives, whichever is shorter, and without clinically significant toxicities from that therapy
- Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK. However, people who received less than 28 days of such treatment and discontinued because of intolerance or...
- Symptomatic or unstable brain metastases that needs corticosteroid usage. people with asymptomatic brain metastases or primary CNS tumors are eligible
- Uncontrolled concurrent malignancy that would limit assessment of how well it works. Allowed diseases may include, but are not limited to in situ cancers of cervix, breast, or skin, superficial bladder cancer...
- Active uncontrolled systemic bacterial, viral, or fungal infection, unstable cardiovascular disease or other systemic disease that would limit compliance with study procedures. Unstable cardiovascular disease is defined...
- Persistently uncontrolled hypertension defined as systolic blood pressure (BP) \> 150 mmHg and/or diastolic BP \> 100 mmHg despite antihypertensive therapy
- Myocardial infarction within 3 months of screening
- Stroke within 3 months of screening
- Inability to discontinue treatment with a strong cytochrome P450 (CYP450), 3A4 (CYP3A4) inhibitor or inducer prior to start of treatment
- Pregnancy or lactation
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.